Page last updated: 2024-11-11

rivaroxaban

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Description

Rivaroxaban: A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

rivaroxaban : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 5-chlorothiophene-2-carboxylic acid with the amino group of 4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one. An anticoagulant used for prophylaxis of venous thromboembolism in patients with knee or hip replacement surgery. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID9875401
CHEMBL ID198362
CHEBI ID68579
SCHEMBL ID3914
MeSH IDM0501463

Synonyms (87)

Synonym
HY-50903
xarelto (tn)
rivaroxaban (jan/usan/inn)
366789-02-8
D07086
RIV ,
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide
rivaroxaban
bay-59-7939
xarelto
c19h18cln3o5s
bay 59-7939
2W26
AKOS005145918
chebi:68579 ,
jnj-39039039
CHEMBL198362
jnj39039039
5-chloro-n-(((5s)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxazolidin-5-yl)methyl)thiophene-2-carboxamide
hsdb 8149
2-thiophenecarboxamide, 5-chloro-n-(((5s)-2-oxo-3-(4-(3-oxo-4-morpholinyl)phenyl)-5-oxazolidinyl)methyl)-
9ndf7jz4m3 ,
unii-9ndf7jz4m3
bay59-7939
rivaroxaban [usan:inn:ban:jan]
(s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide
rivaroxaban,xarelto,bay 59-7939
rivaroxaban [usp-rs]
rivaroxaban [ep monograph]
rivaroxaban [usan]
rivaroxaban [mart.]
rivaroxaban [vandf]
rivaroxaban [orange book]
rivaroxaban [who-dd]
rivaroxaban [inn]
rivaroxaban [jan]
rivaroxaban [ema epar]
rivaroxaban [mi]
5-chloro-n-{[(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl}thiophene-2-carboxamide
CS-0555
gtpl6388
5-chloro-n-[[(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]thiophene-2-carboxamide
BRD-K37130656-001-01-2
DB06228
CCG-212899
MLS006010027
smr002529611
5-chloro-n-[[(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide
SCHEMBL3914
dtxsid3057723 ,
KGFYHTZWPPHNLQ-AWEZNQCLSA-N
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide
5-chloro-n-{[(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]oxazolidin-5-yl]methyl}thiophene-2-carboxamide
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl) phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}-methyl)-2-thiophenecarboxamide
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophene-carboxamide
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophencarboxamide
5-chlor-n-({(5s)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)-2-thiophenecarboxamide
5-chloro-n-({(5s)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl} methyl)thiophene-2-carboxamide
us8822458, 44
us8822458, 97
bdbm7840
Q-102503
AB01563270_01
mfcd11974010
EX-A206
SR-01000944189-1
sr-01000944189
NCGC00379033-04
Q420262
r-rivaroxaban; ent-rivaroxaban; [({(5r)-2-oxo-3-[p-(3-oxo-4-morpholinyl)phenyl]-1,3-oxazolidin-5-yl}methyl)amino](5-chloro-2-thienyl)formaldehyde; 5-chloro-n-[[(5r)-2-oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-2-thiophenecarboxamide
rivaroxaban enantiomer (r-isomer)
1429742-50-6
AMY1799
rivaroxaban; (s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)oxazolidin-5-yl)methyl)thiophene-2-carboxamide
5-chloro-n-[[(s)-3-(4-(3-oxomorpholin-4-yl)phenyl)-2-oxo-1,3-oxazolidin-5-yl]methyl]-thiophene-2-carboxamide
(s)-5-chloro-n-((2-oxo-3-(4-(3-oxomorpholino)phenyl)-oxazolidin-5-yl)methyl)thiophene-2-carboxamide
NCGC00262945-10
BR164355
rivaroxaban- bio-x
EN300-6733490
b01af01
rivaroxaban (ep monograph)
rivaroxaban (usp-rs)
rivaroxabanum
rivaroxaban (mart.)
Z1741977097

Research Excerpts

Overview

Rivaroxaban is a direct inhibitor of activated Factor X (FXa), an anti-inflammatory protein exerting a protective effect on the cardiac valve and vascular endothelium. It is a first-line option for the management of venous thromboembolism (VTE)

ExcerptReferenceRelevance
"Rivaroxaban is a direct inhibitor of factor Xa, a coagulation factor at a critical juncture in the blood coagulation pathway leading to thrombin generation and clot formation. "( Rivaroxaban: a new oral factor Xa inhibitor.
Kubitza, D; Laux, V; Mueck, W; Perzborn, E; Roehrig, S; Straub, A, 2010
)
3.25
"Rivaroxaban is a direct factor Xa inhibitor used for the management of thromboembolic disorders. "( Bioequivalence and Food Effect Assessment of 2 Rivaroxaban Formulations in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, and 4-Period Crossover Study.
Cao, Y; Gao, X; Jiang, X; Li, T; Lin, P; Liu, S; Liu, Y; Ma, Y; Shi, P; Tao, Y, 2022
)
2.42
"Rivaroxaban is a direct inhibitor of activated Factor X (FXa), an anti-inflammatory protein exerting a protective effect on the cardiac valve and vascular endothelium. "( New evidence of direct oral anticoagulation therapy on cardiac valve calcifications, renal preservation and inflammatory modulation.
Bellasi, A; Chimenti, C; Della Rocca, DG; Di Iorio, BR; Di Lullo, L; Forleo, GB; Lavalle, C; Magnocavallo, M; Mancone, M; Mariani, MV; Miraldi, F; Natale, A; Ronco, C; Russo, D; Severino, P; Summaria, F, 2021
)
2.06
"Rivaroxaban is a viable anticoagulant for the management of cancer-associated venous thromboembolism (CA-VTE). "( Application of a physiologically based pharmacokinetic model of rivaroxaban to prospective simulations of drug-drug-disease interactions with protein kinase inhibitors in cancer-associated venous thromboembolism.
Chan, ECY; Cheong, EJY; Chin, SY; Ng, DZW; Wang, Z, 2022
)
2.4
"Rivaroxaban is an oral anticoagulant that inhibits thrombin and blocks coagulation cascade through directly inactivating factors Xa. "( Non-synonymous alterations in AKR7A3 and ABCA6 correlate with bleeding in aged patients treated with rivaroxaban.
Gu, M; Jia, X; Li, R; Tian, C; Wang, X; Yang, L; Zhang, Q; Zhao, M, 2022
)
2.38
"Rivaroxaban is a potential alternative, but data to support its use are limited."( Rivaroxaban for the treatment of noncirrhotic splanchnic vein thrombosis: an interventional prospective cohort study.
Ageno, W; Becattini, C; Bertoletti, L; Beyer Westendorf, J; Bucherini, E; Carrier, M; Contino, L; De Stefano, V; Delluc, A; Di Nisio, M; Donadini, MP; Grandone, E; Lazo-Langner, A; Martinelli, I; Nardo, B; Pomero, F; Riva, N; Santoro, R; Sartori, MT; Schenone, A; Senzolo, M; Tosetto, A, 2022
)
2.89
"Rivaroxaban is a first-line option for the management of venous thromboembolism (VTE). "( Management of Venous Thromboembolism in Morbid Obesity With Rivaroxaban or Warfarin.
Breeden, T; Edwin, SB; Giuliano, C; Haan, B; Ng, TH; Weaver, P, 2022
)
2.41
"Rivaroxaban is a novel anticoagulant that has been widely used in clinic, it has a good pharmacological effects both in vivo and in vitro."( Delivery of rivaroxaban and chitosan rapamycin microparticle with dual antithrombosis and antiproliferation functions inhibits venous neointimal hyperplasia.
Bai, H; He, H; Li, J; Liu, Y; Lou, C; Sun, P; Wu, H; Zhang, C; Zhang, L, 2022
)
1.82
"Rivaroxaban is a potential option for tumor preventive anticoagulation and HIT treatment. "( Advanced lung cancer patient with isolated heparin-induced thrombocytopenia: A case report.
Han, LH; Jiang, H; Shang, Y; Tong, ZY; Wang, WM; Yu, K; Zhao, JY, 2022
)
2.16
"Rivaroxaban is a direct, oral factor Xa inhibitor that is used for the prevention and treatment of various thromboembolic disorders. "( The effect of rivaroxaban on biomarkers in blood and plasma: a review of preclinical and clinical evidence.
Heitmeier, S; Schiffer, S; Schwers, S, 2023
)
2.71
"Rivaroxaban is an oral daily formulation approved for VTE prophylaxis after orthopedic surgery."( Prolonged thromboprophylaxis with rivaroxaban after bariatric interventions: single centre experience.
Kebkalo, A; Poylin, V; Tryliskyy, Y; Tyselskyi, V, 2023
)
1.91
"Rivaroxaban is a direct factor Xa inhibitor, recently implemented as a favorable alternative to warfarin in anticoagulation therapy. "( Profibrinolytic effects of rivaroxaban are mediated by thrombin-activatable fibrinolysis inhibitor and are attenuated by a naturally occurring stabilizing mutation in enzyme.
Boffa, MB; Garabon, JJW, 2023
)
2.65
"Rivaroxaban is a direct oral anticoagulant with the highest risk of anticoagulant-induced major gastrointestinal bleeding (MGIB). "( A nomogram for predicting major gastrointestinal bleeding in patients treated with rivaroxaban.
Cao, H; Chu, X; Dong, Y; Xu, H; Zhang, Z; Zhu, M,
)
1.8
"Rivaroxaban is a DOAC that causes thrombus regression, possibly through a profibrinolytic effect."( Clot regression effects of rivaroxaban in the treatment of venous thromboembolism in patients with cancer (CRERIT-VTE cancer): study protocol.
Fujita, H; Imai, K; Kawasaki, T; Matoba, S; Nakanishi, N; Okada, T; Sawada, T; Takai, S; Yamada, A; Yokota, I, 2019
)
1.53
"Rivaroxaban is a direct oral anti-factor Xa anticoagulant. "( Effects of Rivaroxaban on Platelet Aggregation.
Espejo-Godinez, HG; Hernandez-Juarez, J; Hernandez-Lopez, JR; Isordia-Salas, I; Majluf-Cruz, A; Majluf-Cruz, K; Mancilla-Padilla, R; Moreno, JAA; Moreno-Hernández, M, 2020
)
2.39
"Rivaroxaban is a direct-acting oral anticoagulant approved to prevent strokes in patients with atrial fibrillation. "( Rivaroxaban Precision Dosing Strategy for Real-World Atrial Fibrillation Patients.
Cao, YC; Gehi, AK; Gonzalez, D; Herbert Patterson, J; Kashuba, A; Konicki, R; Powell, JR; Watkins, P; Weiner, D, 2020
)
3.44
"Rivaroxaban is an effective anticoagulant for treating thrombosis of a KD."( A Rare Case of Submassive Pulmonary Embolism with a Right Aberrant Subclavian Artery and Thrombosed Kommerell Diverticulum.
Arimura, T; Komaki, T; Miura, SI; Morii, J; Nakamura, M; Ogawa, M; Onishi, N, 2020
)
1.28
"Rivaroxaban is a particularly valuable treatment option in developing countries, where there are issues of cost and availability of approved alternative agents."( Rivaroxaban as an Alternative Agent for Heparin-Induced Thrombocytopenia.
Ansarinejad, N; Farasatinasab, M; Moghtadaei, M; Nasiripour, S; Zarei, B; Zarei, M, 2020
)
2.72
"Rivaroxaban is a direct oral anticoagulant (DOAC) approved for the treatment of non-valvular atrial fibrillation (NVAF). "( Factors associated with bleeding events in patients on rivaroxaban for non-valvular atrial fibrillation: A real-world experience.
Akhtar, T; Fratti, JDC; Fugar, S; Golzar, Y; Mann, H; Mattumpuram, J; Nwaichi, C; Torres, A; Uprety, A, 2020
)
2.25
"Rivaroxaban is a highly selective factor Xa inhibitor approved for use in Europe for multiple indications."( Rationale and design of a European epidemiological post-authorization safety study (PASS) program: rivaroxaban use in routine clinical practice.
Balabanova, Y; Bezemer, I; Brobert, G; Davies, M; Evans, A; Friberg, L; García-Rodríguez, LA; Herings, R; Ruigomez, A; Schink, T; Shakir, S; Soriano-Gabarró, M; Suzart-Woischnik, K; Vora, P; Wallander, MA, 2020
)
2.22
"Rivaroxaban is a novel, oral direct acting anticoagulant (DOAC) that is used for both treatment and prevention of thromboembolic diseases. "( Thrombocytopenia due to rivaroxaban: A rare adverse effect.
Afacan Öztürk, HB; Akyol, P; Albayrak, M; Aras, MR; Sağlam, B; Tığlıoğlu, M; Yıldız, A, 2020
)
2.31
"Rivaroxaban is a novel oral anticoagulant with potent anti-Xa activity, which might be an attractive alternative drug to enoxaparin."( Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE.
Fang, Z; Hu, X; Liu, Q; Tang, L; Xiao, Y; Zhou, S, 2022
)
1.67
"Rivaroxaban is a new anticoagulant option for dogs, yet its reported oral bioavailability is as low as 60%. "( The influence of feeding and gastroprotectant medications on the Factor Xa inhibitory activity of orally administered rivaroxaban in normal dogs.
Brooks, MB; Griffith, E; Hanel, RM; Lynch, AM; Ruterbories, LK; Stablein, AP, 2021
)
2.27
"Rivaroxaban (RIV) is an oral anticoagulant that is the first available orally active direct inhibitor of factor Xa. "( Review on Characteristics and Analytical Methods of Rivaroxaban.
Çelebier, M; Haznedaroğlu, İC; Reçber, T, 2022
)
2.41
"Rivaroxaban is a specific factor Xa (FXa) inhibitor for venous thromboembolism treatment. "( Factor Xa inhibitor rivaroxaban suppresses experimental abdominal aortic aneurysm progression via attenuating aortic inflammation.
Cai, L; Ding, Y; Fu, W; Li, X; Shi, Z; Tang, H; Xie, T; Zhou, M, 2021
)
2.39
"Rivaroxaban is a factor Xa inhibitor oral anticoagulant first approved for use in the United States in 2011. "( The Pharmacology, Efficacy, and Safety of Rivaroxaban in Renally Impaired Patient Populations.
Ashton, V; Kerolus-Georgi, S; Moore, KT, 2021
)
2.33
"Rivaroxaban is a direct inhibitor of activated factor Xa and has the advantage of predictable pharmacodynamics and pharmacokinetics, no coagulation monitoring, and few drug interactions."( Current use of rivaroxaban in elderly patients with venous thromboembolism (VTE).
Cai, Q; Chen, H; Hu, C; Liao, K; Wang, X; Zhang, X, 2021
)
1.7
"Rivaroxaban is a selective inhibitor of coagulation factor Xa and its combination with aspirin showed better outcomes in the prevention of recurrent cardiovascular disease than aspirin alone."( Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy.
Cortesi, PA; Di Laura, D; Ferrara, P; Maggioni, AP; Mantovani, LG, 2021
)
2.35
"Rivaroxaban is an anticoagulant (orally active direct Xa inhibitor) considered to reduce the risk of stroke and systemic embolism and treat deep vein thrombosis, pulmonary embolism, and other cardiovascular complications. "( Sensitive LC-MS/MS method for quantification of rivaroxaban in plasma: Application to pharmacokinetic studies.
Antônio, MA; Carvalho, PO; Cirino, JPG; Coelho, EC; Davanço, MG; de Campos, DR; de Oliveira, AC; Porcari, AM; Sanches, PHG, 2021
)
2.32
"Rivaroxaban is a commonly used anticoagulant agent for treatment and prevention of thromboembolism. "( Acute liver failure after changing oral anticoagulant from apixaban to rivaroxaban.
Munasinghe, A; Rao, V, 2021
)
2.3
"Rivaroxaban is an oral anticoagulant widely used for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). "( How to handle the delayed or missed dose of rivaroxaban in patients with non-valvular atrial fibrillation: model-informed remedial dosing.
Jiao, Z; Li, ZR; Liu, XQ; Wang, CY; Yin, YW; Zhu, X, 2021
)
2.33
"Rivaroxaban is a direct inhibitor of activated coagulation factor X and competitively targets factor Xa via reversible binding. "( Rivaroxaban for treatment of livedoid vasculopathy: A systematic review.
Gao, Y; Jin, H, 2021
)
3.51
"Rivaroxaban is a suitable alternative to LMWH for patients who prefer not to have injections."( Effect of different initial anticoagulant strategies on short-term outcome of patients with symptomatic DVT in China.
Dart, AM; Fan, F; Song, Q; Wang, Y; Zhang, P; Zhang, Y; Zou, Y, 2021
)
1.34
"Rivaroxaban is a direct oral anticoagulant (DOAC) used for prophylaxis and treatment of many prothrombotic states. "( Indirect antiplatelet effects of rivaroxaban in a patient with intracranial hemorrhage: An underappreciated coagulopathy of factor Xa inhibitors?
Gilbert, BW; Tabaka, CA, 2022
)
2.45
"Rivaroxaban is an oral direct factor Xa inhibitor approved for the treatment of stroke and systemic thromboembolism in patients with non-valvular atrial fibrillation. "( Angiotensin II promotes the anticoagulant effects of rivaroxaban via angiotensin type 2 receptor signaling in mice.
Chen, H; Hu, R; Liu, C; Shao, J; Xie, P; Yang, D, 2017
)
2.15
"Rivaroxaban is a direct and selective inhibitor of factor Xa. "( [Use of rivaroxaban in real-life treatment of venous thromboembolism: results of the TEV Survey, an Italian epidemiological study].
Iori, I; Pesavento, R, 2017
)
2.33
"Rivaroxaban is an oral anticoagulant that provides rapid onset of anticoagulation."( Rivaroxaban Used in the Treatment Patients With Gynecologic Cancer and Venous Thromboembolism: The Experience of Instituto Nacional de Câncer-Rio de Janeiro, Brazil.
Araujo, MLC; Bergmann, A; de Morais E Coura, CP; Renni, MJP; Trugilho, I, 2017
)
2.62
"Rivaroxaban is a novel oral anticoagulant associated with a significantly lower risk of major bleeds (hazard ratio = 0.54, 95% confidence interval = 0.37-0.79) compared to LMWH/VKA therapy, and does not require regular anticoagulation monitoring."( Cost-effectiveness analysis of rivaroxaban for treatment and secondary prevention of venous thromboembolism in the Netherlands.
Giesen, EBW; Heemstra, HE; Heisen, M; Postma, MJ; Treur, MJ, 2017
)
1.46
"Rivaroxaban is a direct oral anticoagulant that is prescribed for the prevention and treatment of thromboembolisms. "( A case of rivaroxaban-associated acute tubulointerstitial nephritis.
Gabreëls, BATF; Monahan, RC; Suttorp, MM, 2017
)
2.3
"Rivaroxaban is an oral, direct factor Xa inhibitor used in human thrombotic disorders. "( Anticoagulant activity of oral rivaroxaban in healthy dogs.
Blais, MC; Conversy, B; Del Castillo, JRE; Dunn, M; Gara-Boivin, C, 2017
)
2.18
"Rivaroxaban is a novel oral anticoagulant indicated for prophylaxis against deep vein thrombosis and pulmonary embolism in patients undergoing total hip replacement (THR) or total knee replacement (TKR) surgery."( A post-marketing assessment of major bleeding in total hip and total knee replacement surgery patients receiving rivaroxaban.
Hopf, KP; Kwong, LM; Patel, MR; Peacock, WF; Sicignano, N; Tamayo, S; Turpie, AGG; Yuan, Z, 2017
)
2.11
"Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. "( Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.
Czosnowski, L; Dalsing, M; Fajardo, A; Gupta, A; Mokraoui, N; Motaganahalli, R; Talukdar, A; Wang, SK, 2017
)
2.21
"Rivaroxaban is a direct oral anticoagulant (DOAC) approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a common arrhythmia. "( Comparative effectiveness of rivaroxaban in the treatment of nonvalvular atrial fibrillation.
Alonso, A; Norby, FL, 2017
)
2.19
"Rivaroxaban is a novel oral anticoagulant with several indications, one of which is for stroke prevention in nonvalvular atrial fibrillation. "( Probable Rivaroxaban-Induced Full Body Rash: A Case Report.
Cohen, H; James, M; Russell, M; Sasson, E; Todorov, D, 2018
)
2.34
"Rivaroxaban is an oral selective anti Xa inhibitor with well predictive pharmacokinetics and pharmacodynamics."( [Rivaroxaban in high-risk patients].
Špinar, J; Špinarová, L,
)
1.76
"Rivaroxaban is an oral anticoagulant approved in the US for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). "( Comparative effectiveness of rivaroxaban versus warfarin or dabigatran for the treatment of patients with non-valvular atrial fibrillation.
Alonso, A; Bengtson, LGS; Chamberlain, AM; Chen, LY; Lutsey, PL; MacLehose, RF; Norby, FL; Rapson, I, 2017
)
2.19
"Rivaroxaban is a potent, oral, direct, factor Xa inhibitor approved for the prevention and treatment of thromboembolic events, including VTE."( Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial.
Belani, C; Beyers, K; Damaraju, CV; Dietrich, F; Eikelboom, J; Kakkar, AK; Khorana, AA; Kuderer, NM; Liebman, H; Lyman, GH; McBane, R; O'Reilly, EM; Peixoto, RD; Riess, H; Soff, G; Vadhan-Raj, S; Wun, T, 2017
)
2.62
"Rivaroxaban is a new oral anticoagulant for stroke prevention in patients with non-valvular atrial fibrillation (NVAF), which has less drug-food interaction than warfarin. "( Metabolic benefits of rivaroxaban in non-valvular atrial fibrillation patients after radiofrequency catheter ablation.
Chen, SQ; Cheng, H; Gao, RJ; Jiang, CY; Jiang, RH; Lin, JW; Liu, Q; Sheng, X; Sun, YX; Ye, Y; Yu, L; Zhang, P; Zhang, ZW; Zhu, J,
)
1.89
"Rivaroxaban (RXB) is an orally active direct inhibitor of the activated serine protease Factor Xa, given as monotherapy in the treatment of venous thromboembolism (VTE). "( Enhanced Biopharmaceutical Performance of Rivaroxaban through Polymeric Amorphous Solid Dispersion.
Chand, M; Metre, S; Mukesh, S; Samal, SK; Sangamwar, AT, 2018
)
2.19
"Rivaroxaban is a direct oral anticoagulant with a large inter-individual variability. "( Application of physiologically based pharmacokinetic modeling to the prediction of drug-drug and drug-disease interactions for rivaroxaban.
Ge, W; Jiang, Q; Xu, R, 2018
)
2.13
"Rivaroxaban is a non-vitamin K antagonist oral anticoagulant that acts as a direct factor Xa inhibitor, and is widely used for the prevention and treatment of thromboembolic disorders. "( The Rivaroxaban Program and the Management of Unmet Needs in Thromboembolic Disease.
Camm, AJ, 2018
)
2.48
"Rivaroxaban (RXA) is a direct oral factor Xa (Xa) antagonist with a short half-life and a fast onset and offset of effect. "( Risk Factors for Higher-than-Expected Residual Rivaroxaban Plasma Concentrations in Real-Life Patients.
Jetter, A; Kaserer, A; Schedler, A; Seifert, B; Spahn, DR; Stein, P; Studt, JD, 2018
)
2.18
"Rivaroxaban is an effective and safe alternative to warfarin in patients with atrial fibrillation and venous thromboembolism. "( Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome.
Andreoli, L; Banzato, A; Barcellona, D; Cafolla, A; Cenci, C; De Micheli, V; Denas, G; Falanga, A; Fierro, T; Gerosa, M; Ghirarduzzi, A; Gresele, P; Hoxha, A; Jose, SP; Martinelli, I; Pengo, V; Prisco, D; Ruffatti, A; Testa, S; Tincani, A; Tosetto, A; Zoppellaro, G, 2018
)
3.37
"Rivaroxaban is a potential option for patients with cancer and VTE."( Rivaroxaban versus enoxaparin for the prevention of recurrent venous thromboembolism in patients with cancer: A meta-analysis.
Chen, D; Xing, J; Yin, X, 2018
)
2.64
"Rivaroxaban is a non-vitamin K antagonist oral anticoagulant. "( Routine coagulation test abnormalities caused by rivaroxaban: A case report.
Cao, H; Qin, L; Song, Z; Tang, M; Wu, H; Yang, S, 2018
)
2.18
"Rivaroxaban (RIV) is an oral anticoagulant used in the prevention of venous thromboembolism in adult patients after total hip replacement or total knee replacement surgery. "( β-Cyclodextrin-based inclusion complexes and nanocomposites of rivaroxaban for solubility enhancement.
Jadhav, M; Sherje, AP, 2018
)
2.16
"Rivaroxaban is a substrate for ABCB1 transporter and is commonly used in patients undergoing hip or knee replacement surgery for thromboprophylaxis. "( Downregulation of ABCB1 gene in patients with total hip or knee arthroplasty influences pharmacokinetics of rivaroxaban: a population pharmacokinetic-pharmacodynamic study.
Grabnar, I; Mrhar, A; Petre, M; Pišlar, M; Potočnik, U; Repnik, K; Vogrin, M; Zdovc, J, 2019
)
2.17
"Rivaroxaban is a novel oral medication that directly inhibits factor Xa for the prevention and treatment of thromboembolic conditions."( Effectiveness and safety of rivaroxaban for the prevention of thrombosis following total hip or knee replacement: A systematic review and meta-analysis.
Liu, J; Su, J; Yan, Y; Zhao, J, 2019
)
1.53
"Rivaroxaban (RIV) is a direct oral anticoagulant (DOAC) targeting activated coagulation factor X (FXa). "( An unexpected dynamic binding mode between coagulation factor X and Rivaroxaban reveals importance of flexibility in drug binding.
Ding, Q; Huang, R; Li, CD; Li, F; Qu, SY; Wei, DQ; Wu, W; Xu, Q, 2019
)
2.19
"Rivaroxaban is a non-vitamin K oral anticoagulant and has been approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). "( Initial rivaroxaban dosing in patients with atrial fibrillation.
Ablefoni, K; Bollmann, A; Buchholz, A; Dagres, N; Hilbert, S; Hindricks, G; Husser, D; Ueberham, L, 2019
)
2.39
"Rivaroxaban is a direct oral anticoagulant administered to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). "( Real-world outcomes of rivaroxaban treatment in patients with nonvalvular atrial fibrillation and worsening renal function.
Ikeda, T; Kidani, Y; Kitazono, T; Minematsu, K; Miyamoto, S; Murakawa, Y; Nakagawara, J; Ogawa, S; Okayama, Y; Sato, S; Sunaya, T; Takeichi, M; Yamanaka, S, 2019
)
2.27
"Rivaroxaban (Xarelto®) is an oral Factor Xa inhibitor approved in many countries for long-term treatment of patients with atrial fibrillation or venous thromboembolism."( Clinical management of rivaroxaban-treated patients.
Ageno, W; Ferrari, A; Filippi, A; Imberti, D; Palareti, G; Pengo, V; Rubboli, A; Toni, D, 2013
)
1.42
"Rivaroxaban is a direct factor Xa inhibitor, which is rapidly absorbed in the upper gastrointestinal (GI) tract. "( Pharmacokinetics of rivaroxaban after bariatric surgery: a case report.
Beyer-Westendorf, J; Gehrisch, S; Mahlmann, A, 2013
)
2.16
"Rivaroxaban is a direct inhibitor of activated factor X, and dabigatran is a direct inhibitor of thrombin. "( [New oral anticoagulants in the treatment of venous thromboembolic disease].
Calvo Romero, JM; Lima Rodríguez, EM, 2013
)
1.83
"Rivaroxaban is an attractive new treatment option for ACS."( Rivaroxaban for the treatment of acute coronary syndromes.
White, HD; Wong, CK, 2013
)
2.55
"Rivaroxaban is an oral, direct factor Xa inhibitor for the management of thromboembolic disorders. "( Reversal of rivaroxaban anticoagulation by haemostatic agents in rats and primates.
Buchmueller, A; Buetehorn, U; Gruber, A; Heitmeier, S; Laux, V; Marzec, UM; Perzborn, E; Tinel, H, 2013
)
2.21
"Rivaroxaban is a factor Xa inhibitor that was recently reviewed by the Food and Drug Administration as a potential therapy to reduce the risk of recurrent atherothrombotic events in patients with acute coronary syndromes. "( The ATLAS ACS 2-TIMI 51 trial and the burden of missing data: (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects With Acute Coronary Syndrome ACS 2-Thrombolysis In Myocardial Infarction 51).
Kaul, S; Krantz, MJ, 2013
)
1.83
"Rivaroxaban is an oral, direct Factor Xa inhibitor that targets free and clot-bound Factor Xa and Factor Xa in the prothrombinase complex. "( Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2014
)
2.09
"Rivaroxaban is an oral direct factor X inhibitor used in human thrombotic disorders and its oral administration makes it an attractive potential anticoagulant for dogs. "( Rivaroxaban demonstrates in vitro anticoagulant effects in canine plasma.
Blais, MC; Carioto, L; Conversy, B; del Castillo, JR; Dunn, M; Gara-Boivin, C, 2013
)
3.28
"Rivaroxaban is an oral direct factor Xa inhibitor that is noninferior to warfarin in the prevention of recurrent venous thromboembolism (VTE). "( Cost-effectiveness of rivaroxaban versus warfarin anticoagulation for the prevention of recurrent venous thromboembolism: a U.S. perspective.
Ragni, MV; Seaman, CD; Smith, KJ, 2013
)
2.15
"Rivaroxaban is an oral highly selective direct factor Xa inhibitor. "( [Practical issues with the use of rivaroxaban].
Roldán, V; Suárez-Fernández, C; Vivancos, J, 2013
)
2.11
"Rivaroxaban is a cost-effective option for anticoagulation treatment of acute VTE patients."( Cost-effectiveness of rivaroxaban compared with enoxaparin plus a vitamin K antagonist for the treatment of venous thromboembolism.
Bookhart, BK; Coleman, CI; Huynh, L; Lefebvre, P; Mody, SH; Nutescu, EA; Tran, KN; Wang, ST; Zhuo, DY, 2014
)
2.16
"Rivaroxaban is an oral factor Xa inhibitor with a predictable pharmacokinetic profile, allowing for a fixed-dose regimen without the need for coagulation monitoring. "( Inaccuracy of point-of-care international normalized ratio in rivaroxaban-treated patients.
Baruch, L; Sherman, O, 2013
)
2.07
"Rivaroxaban is a direct competitive factor Xa inhibitor that is taken orally."( Effectiveness of rivaroxaban for thromboprophylaxis of prosthetic heart valves in a porcine heterotopic valve model.
Greiten, LE; McKellar, SH; Rysavy, J; Schaff, HV, 2014
)
1.46
"Rivaroxaban (Xarelto(®)) is an orally administered highly selective direct inhibitor of factor Xa that has been approved in many countries to reduce the risk of stroke in patients with atrial fibrillation and for the treatment and prevention of venous thromboembolism. "( Rivaroxaban: a review of its use in acute coronary syndromes.
Plosker, GL, 2014
)
3.29
"Rivaroxaban is an ideal potential candidate for treatment of heparin-induced thrombocytopenia (HIT) because it is administered orally by fixed dosing, requires no laboratory monitoring and is effective in the treatment of venous and arterial thromboembolism in other settings. "( Design of the rivaroxaban for heparin-induced thrombocytopenia study.
Crowther, MA; Linkins, LA; Manji, RA; Pai, M; Shivakumar, S; Warkentin, TE; Wells, PS, 2014
)
2.21
"Rivaroxaban is a direct factor Xa inhibitor that is widely available to reduce the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation and one or more risk factors for stroke. "( Practical guidance for using rivaroxaban in patients with atrial fibrillation: balancing benefit and risk.
Bode, C; Haas, S; Norrving, B; Turpie, AG, 2014
)
2.14
"Rivaroxaban is an oral direct factor Xa inhibitor that has been marketed worldwide since 2008 for the primary and secondary prevention and treatment of thromboembolic disorders. "( Rivaroxaban postmarketing risk of liver injury.
Budmiger, M; Hürlimann, S; Kullak-Ublick, GA; Niedrig, DF; Russmann, S; Schmidt, C; Stieger, B, 2014
)
3.29
"Rivaroxaban is a new once-daily oral anticoagulant that overcomes some of these limitations (i.e., no monitoring of anticoagulant effect required and fixed doses can be prescribed)."( Rivaroxaban and stroke prevention in patients with atrial fibrillation: new evidence.
Dan, GA; Kaski, JC; Martínez-Rubio, A, 2014
)
2.57
"Rivaroxaban is a once daily oral anticoagulant, currently indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for the prevention and treatment of venous thromboembolism."( Resolution of left ventricular thrombus by rivaroxaban.
Fernández Guerrero, JC; Garcelán Trigo, JA; Lozano Cabezas, C; Padilla Pérez, M; Salas Bravo, D; Torres Llergo, J; Vazquez Ruiz de Castroviejo, E, 2014
)
1.39
"Rivaroxaban is an oral anticoagulant agent that directly inhibits Factor Xa and interrupts both the intrinsic and extrinsic pathway of the coagulation cascade and is currently indicated for use in patients for atrial fibrillation and prophylaxis of deep venous thrombosis. "( Spontaneous rectus sheath hematoma during rivaroxaban therapy.
Aydın, E; Can, Y; Gunduz, H; Kılıc, H; Kocayigit, I; Sahinkus, S; Vatan, MB,
)
1.84
"Rivaroxaban is a newer anticoagulant initially approved by the Food and Drug Administration to treat nonvalvular atrial fibrillation. "( A case of rivaroxaban associated intracranial hemorrhage.
Gerona, RR; Lo, JC, 2014
)
2.25
"Rivaroxaban is a direct factor Xa inhibitor approved for prevention of stroke, prevention and treatment of venous thromboembolism and secondary prevention of acute coronary syndrome in many countries. "( Monitoring the anticoagulant effect after a massive rivaroxaban overdose.
Linkins, LA; Moffat, K, 2014
)
2.1
"Rivaroxaban is a novel anticoagulant approved for use in patients with atrial fibrillation for stroke prevention. "( Isolated hemopericardium associated with rivaroxaban: first case report.
Brar, N; Shivamurthy, P; Therrien, ML, 2014
)
2.11
"Rivaroxaban is a novel, selective and potent oral direct factor Xa inhibitor, therapeutically indicated in the treatment of thromboembolic diseases. "( A validated high-throughput UHPLC-MS/MS assay for accurate determination of rivaroxaban in plasma sample.
Imam, F; Iqbal, M; Khalid Anwer, M; Khalil, NY, 2015
)
2.09
"Oral rivaroxaban appears to be an effective and safe alternative to VKAs and may allow prompt cardioversion."( Rivaroxaban vs. vitamin K antagonists for cardioversion in atrial fibrillation.
Camm, AJ; Cappato, R; Ezekowitz, MD; Hemmrich, M; Hohnloser, SH; Kirchhof, P; Klein, AL; Lanius, V; Le Heuzey, JY; Ma, CS; Meng, IL; Scanavacca, M; Talajic, M; van Eickels, M; Vardas, PE; Wildgoose, P, 2014
)
2.36
"Rivaroxaban is an oral anticoagulant that effectively prevents thromboembolic complications using fixed doses without requiring laboratory monitoring. "( Impact of rivaroxaban compared with warfarin on the coagulation status in Japanese patients with non-valvular atrial fibrillation: a preliminary analysis of the prothrombin fragment 1+2 levels.
Aonuma, K; Harunari, T; Sato, A; Shimojo, N; Tajiri, K; Yamaguchi, I, 2015
)
2.26
"Rivaroxaban is a factor Xa inhibitor recently approved for use in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE). "( Rivaroxaban for treatment of venous thromboembolism in older adults.
Conway, SE; Mitchell, AP, 2014
)
3.29
"Rivaroxaban is a new oral anticoagulant that functions as a direct anti-Xa inhibitor. "( Comparison of anti-Xa and dilute Russell viper venom time assays in quantifying drug levels in patients on therapeutic doses of rivaroxaban.
Adcock Funk, DM; Francart, SJ; Friedman, KD; Gosselin, RC; Hawes, EM; Moll, S; Taylor, JM, 2014
)
2.05
"Rivaroxaban is an oral, direct Factor Xa inhibitor, approved for the treatment of pulmonary embolism (PE) and deep vein thrombosis (DVT) and the secondary prevention of recurrent PE and DVT as a fixed-dose, monotherapy regimen that does not require initial heparinisation, routine coagulation monitoring or dose adjustment. "( Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial.
Bamber, L; Bauersachs, R; Cano, SJ; Erkens, P; Lensing, AW; Prins, MH; Wang, MY, 2015
)
2.11
"Rivaroxaban is a new oral direct factor Xa inhibitor with a wide therapeutic window, predictable anticoagulant effect, no food interactions, and few drug interactions."( Rivaroxaban in the treatment of venous thromboembolism and the prevention of recurrences: a practical approach.
Arcelus, JI; Domènech, P; Fernández-Capitan, Mdel C; Guijarro, R; Jiménez, D; Jiménez, S; Lozano, FS; Monreal, M; Nieto, JA; Páramo, JA, 2015
)
2.58
"Rivaroxaban is an oral direct factor Xa inhibitor increasingly used in stroke prevention in nonvascular atrial fibrillation, primary prevention and treatment of venous thromboembolism, and secondary prevention in acute coronary syndromes."( Intravenous thrombolysis for acute ischemic stroke in a patient receiving rivaroxaban.
Ginoux, C; Landais, A, 2015
)
2.09
"Rivaroxaban is an oral, selective direct factor Xa inhibitor approved for several indications in patients at risk of thrombotic events. "( Correlation of coagulation markers and 4F-PCC-mediated reversal of rivaroxaban in a rabbit model of acute bleeding.
Dickneite, G; Doerr, B; Herzog, E; Kaspereit, F; Krege, W; Mueller-Cohrs, J; Niebl, P, 2015
)
2.1
"Rivaroxaban is an oral factor Xa inhibitor approved for stroke prevention in atrial fibrillation (AF) and for treatment and prevention of venous thromboembolism (VTE) in major orthopedic surgery."( Periprocedural management of rivaroxaban-treated patients.
Ambrosoli, A; Cimminiello, C; Compagnone, C; Fanelli, A; Imberti, D; Ottani, F; Tripodi, A, 2015
)
1.43
"Rivaroxaban is a safe and effective drug that simplifies management of anticoagulation also in patients undergoing invasive procedures. "( Periprocedural management of rivaroxaban-treated patients.
Ambrosoli, A; Cimminiello, C; Compagnone, C; Fanelli, A; Imberti, D; Ottani, F; Tripodi, A, 2015
)
2.15
"Rivaroxaban is a once-daily oral anticoagulant currently marketed for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation. "( Efficacy and safety of rivaroxaban in real-life patients with atrial fibrillation.
Atienza, F; Barón-Esquivias, G; Fernández-Avilés, F; Pastor Pueyo, P; Sanmartín Fernández, M; Toro, R, 2015
)
2.17
"Rivaroxaban is a newer oral anticoagulant with a favorable regimen due to lack of frequent blood monitoring and fewer drug interactions."( Spontaneous, Life-Threatening Hemorrhagic Cardiac Tamponade Secondary to Rivaroxaban.
Kham, NM; Song, M,
)
1.08
"Rivaroxaban is an oral anticoagulant that works by inhibiting factor Xa leading to a blockage of thrombin production, which inhibits platelet aggregation and thrombus formation."( Left atrial thrombus formation after brief interruption of rivaroxaban.
Solarz, D; Turner, M, 2016
)
1.4
"Rivaroxaban is a once-daily oral anticoagulant currently indicated for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. "( Reversal of rivaroxaban anticoagulation by nonactivated prothrombin complex concentrate in urgent surgery.
Chic Acevedo, C; Herrera, C; Velasco, F, 2015
)
2.24
"Rivaroxaban is an anticoagulant prescribed for the management of atrial fibrillation. "( Association of rivaroxaban anticoagulation and spontaneous vitreous hemorrhage.
Hwang, JC; Jun, JH, 2015
)
2.21
"Rivaroxaban is a new oral anticoagulant frequently used in an increasing number of indications."( Assessing the influence of diurnal variations and selective Xa inhibition on whole blood aggregometry.
Brunner, M; Brunner-Ziegler, S; Jilma, B; Schoergenhofer, C; Schwameis, M; Winkler, F; Zeitlinger, M, 2015
)
1.14
"Rivaroxaban is a new Xa inhibitor indicated for thromboprophylaxis in patients undergoing joint arthroplasty. "( Combination of Superficial and Deep Blocks with Rivaroxaban.
Chelly, JE; Luke, C; Metais, B; Schilling, D; Taormina, D, 2015
)
2.12
"Rivaroxaban is a new oral anticoagulant (NOAC) that can be prescribed in a fixed dose, making regular monitoring and dose adjustments unnecessary. "( Clinical impact and course of major bleeding with rivaroxaban and vitamin K antagonists.
Büller, HR; Eerenberg, ES; Lensing, AW; Levi, M; Middeldorp, S, 2015
)
2.11
"Rivaroxaban is a convenient oral anticoagulant for patients with venous thromboembolism (VTE). "( Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists.
De Crem, N; Debaveye, B; Middeldorp, S; Peerlinck, K; Peetermans, M; Vanassche, T; Vanheule, K; Verhamme, P, 2015
)
2.11
"Rivaroxaban is an oral anticoagulant approved for prevention of stroke, as well as for the treatment and prevention of venous thromboembolic disease. "( Cardiac Tamponade Associated with Rivaroxaban.
Boone, S, 2015
)
2.14
"Rivaroxaban is a factor-Xa-inhibitor which has been shown to be non-inferior to the vitamin-K-antagonist (VKA) warfarin in atrial fibrillation patients. "( Fatal intracerebral bleeding under rivaroxaban.
Bastovansky, A; Finsterer, J; Stöllberger, C, 2015
)
2.14
"Rivaroxaban is an oral direct factor Xa (FXa) inhibitor clinically used to prevent and treat thromboembolic disorders. "( Chiral Inhibition of Rivaroxaban Derivatives Towards UDP-Glucuronosyltransferase (UGT) Isoforms.
Deng, J; Fang, ZZ; Hu, CM; Hu, L; Liu, YZ; Lu, D; Ma, AL; Wang, H; Wang, SF; Yang, K; Yao, Z; Zhang, YY, 2015
)
2.18
"Rivaroxaban is a new anticoagulant drug that has recently been introduced for clinical applications. "( Rapid determination of rivaroxaban in human urine and serum using colloidal palladium surface-assisted laser desorption/ionization mass spectrometry.
Chang, SY; Chen, WC; Cheng, YH, 2015
)
2.17
"Rivaroxaban is a direct factor Xa inhibitor that has been extensively studied and is now approved for the prevention and therapy of a number of thromboembolic conditions."( Efficacy and safety of rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome: Rationale and design of the Trial on Rivaroxaban in AntiPhospholipid Syndrome (TRAPS) trial.
Banzato, A; Bison, E; Denas, G; Padayattil Jose, S; Pengo, V; Zoppellaro, G, 2016
)
1.47
"Rivaroxaban is a factor Xa inhibitor that prevents VTE after THA or TKA."( Rivaroxaban in preventing venous thromboembolism after arthroplastic surgery in Taiwan.
Chen, CH; Chen, ST; Gan, KH; Hsieh, KP; Mao, YC, 2015
)
2.58
"Rivaroxaban is a target-specific oral anticoagulant approved for the treatment of venous thromboembolism (VTE). "( Enoxaparin Treatment Followed by Rivaroxaban for the Treatment of Acute Lower Limb Venous Thromboembolism: Initial Experience in a Single Center.
Fukuda, JM; Guerra, JC; Krutman, M; Kuzniec, S; Ramacciotti, E; Teivelis, M; Varella, AY; Wolosker, N, 2016
)
2.16
"Rivaroxaban therapy is a useful therapeutic option in patients with APE. "( Acute pulmonary embolism treatment with rivaroxaban results in a shorter duration of hospitalisation compared to standard therapy: an academic centre experience.
Burzyński, Ł; Ciurzyński, M; Dzikowska-Diduch, O; Goliszek, S; Kostrubiec, M; Kurnicka, K; Lichodziejewska, B; Paczyńska, M; Pruszczyk, P; Sobieraj, P,
)
1.84
"Rivaroxaban is a direct factor Xa inhibitor that prevents thrombus formation."( Anticoagulation with rivaroxaban for livedoid vasculopathy (RILIVA): a multicentre, single-arm, open-label, phase 2a, proof-of-concept trial.
Drabik, A; Eveslage, M; Gerss, J; Goerge, T; Kahle, B; Kreuter, A; Schneider, SW; Strölin, A; Weishaupt, C, 2016
)
1.47
"Rivaroxaban is a potent new oral anticoagulant that has been approved for use by National Institute for Health and Care Excellence (NICE) but still has no approved reversal agent."( Rivaroxaban and retropharyngeal haemorrhage.
Bell, PR; McCadden, L; McCarter, JA; Scally, C, 2016
)
2.6
"Rivaroxaban is an oral anticoagulant, which directly inhibits Factor Xa."( Comparison of rivaroxaban mono-therapy and standard-therapy adjusted by CYP2C9 and VKORC1 genotypes in symptomatic pulmonary embolism.
Chen, R; Duan, L; Guo, Y; Hong, C; Liu, C; Su, X; Yan, H; Yang, X; Zhang, N; Zhong, N; Zhou, Y, 2016
)
1.52
"Rivaroxaban is an oral anticoagulant that acts as a direct, competitive factor Xa inhibitor. "( Failure of old and new anticoagulants to prevent ischemic stroke in high-risk atrial fibrillation: a case report.
Adamo, A; Bilora, F; Pomerri, F; Prandoni, P, 2016
)
1.88
"Rivaroxaban is a valuable treatment option for patients with biological prostheses, repaired mitral valves, or a tubular aortic graft in order to prevent thromboembolic complications."( Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis.
Acanfora, C; Acanfora, D; Casucci, G; Ciccone, MM; Dentamaro, I; Furgi, G; Incalzi, RA; Lanzillo, B; Longobardi, M; Scicchitano, P; Zito, A, 2016
)
2.14
"Rivaroxaban is a member of the novel target-specific oral anticoagulants (TSOACs) family of drugs recently approved for the prevention and treatment of venous thromboembolism events. "( Rivaroxaban-Induced Gastrointestinal Bleeding Presenting as Acute Colon Obstruction.
Becker, A; Cohen, M; Hershko, D; Nevo, H, 2017
)
3.34
"Rivaroxaban is an oral direct Factor Xa inhibitor approved in the European Union and the United Sates for the single-drug treatment of several thromboembolic diseases in adults. "( Rivaroxaban-induced chest wall spontaneous expanding hematoma.
Salemis, NS, 2017
)
3.34
"Rivaroxaban is an oral direct factor Xa inhibitor, therapeutically indicated in the treatment of thromboembolic diseases. "( Determination of rivaroxaban in patient's plasma samples by anti-Xa chromogenic test associated to High Performance Liquid Chromatography tandem Mass Spectrometry (HPLC-MS/MS).
Colombini, MP; de Aranda, VF; Derogis, PB; Faulhaber, AC; Ferreira, CE; França, CN; Guerra, JC; Katz, M; Mangueira, CL; Mendes, CE; Sanches, LR, 2017
)
2.24
"Rivaroxaban is an oral direct Xa inhibitor that can lead to prolongation of prothrombin time and activated partial thromboplastin time. "( Prolongation of prothrombin time in the presence of rivaroxaban: is this the only cause?
McRae, S; Sagheer, S, 2017
)
2.15
"Rivaroxaban is an oral, direct activated Factor Xa (FXa) inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. "( Rivaroxaban--an oral, direct Factor Xa inhibitor--has potential for the management of patients with heparin-induced thrombocytopenia.
Bakhos, M; Hoppensteadt, D; Iqbal, O; Jeske, WP; Maddineni, J; Messmore, HL; Prechel, M; Walenga, JM, 2008
)
3.23
"Rivaroxaban is a promising alternative to traditional anticoagulants for the prevention and treatment of venous thromboembolism and for stroke prevention in atrial fibrillation; it offers once-daily oral administration without the need for routine monitoring."( Rivaroxaban: an oral direct inhibitor of factor Xa.
Gulseth, MP; Michaud, J; Nutescu, EA, 2008
)
3.23
"Rivaroxaban (Xarelto) is an oral, direct factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. "( Population pharmacokinetics and pharmacodynamics of once- and twice-daily rivaroxaban for the prevention of venous thromboembolism in patients undergoing total hip replacement.
Borris, LC; Dahl, OE; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F; Mueck, W; Muelhofer, E, 2008
)
2.02
"Rivaroxaban (Xarelto) is a member of a new class of oral, direct (antithrombin-independent) factor Xa inhibitors, which restrict thrombin generation both in vitro and in vivo. "( New compounds in the management of venous thromboembolism after orthopedic surgery: focus on rivaroxaban.
Borris, LC, 2008
)
2.01
"Rivaroxaban is a novel, oral factor Xa inhibitor in clinical development for the treatment and prevention of thromboembolic diseases."( Rivaroxaban: a novel, oral, direct factor Xa inhibitor.
Abrams, PJ; Emerson, CR, 2009
)
2.52
"Rivaroxaban (Xarelto) is a new oral, direct and selective inhibitor of the factor Xa of the coagulation cascade. "( [Rivaroxaban: clinical pharmacology].
Laporte, S; Mismetti, P, 2008
)
2.7
"Rivaroxaban is a novel, oral, direct factor Xa inhibitor for the prevention and treatment of thromboembolic disorders. "( Metabolism and excretion of rivaroxaban, an oral, direct factor Xa inhibitor, in rats, dogs, and humans.
Kubitza, D; Lang, D; Mueck, W; Schwarz, T; Weinz, C, 2009
)
2.09
"Rivaroxaban is a novel oral direct factor Xa inhibitor. "( Rivaroxaban: an oral direct factor Xa inhibitor for the prevention of thromboembolism.
Chen, T; Lam, S,
)
3.02
"Rivaroxaban is an oral direct factor Xa inhibitor that has been effective in prevention of venous thromboembolism in patients undergoing elective orthopaedic surgery. "( Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial.
Barnathan, ES; Bordes, P; Braunwald, E; Burton, P; Gibson, CM; Hricak, V; Markov, V; Mega, JL; Misselwitz, F; Mohanavelu, S; Oppenheimer, L; Poulter, R; Witkowski, A, 2009
)
3.24
"Rivaroxaban (Xarelto) is a direct factor Xa inhibitor and dabigatran etexilate (Pradaxa) is a prodrug of the active compound dabigatran, which inhibits thrombin."( A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the irish healthcare setting.
Barry, M; McCullagh, L; Tilson, L; Walsh, C, 2009
)
1.35
"Rivaroxaban is a novel, oral, direct factor Xa (FXa) inhibitor for the prevention and treatment of thromboembolic disorders. "( Safety, pharmacokinetics and pharmacodynamics of single doses of rivaroxaban - an oral, direct factor Xa inhibitor - in elderly Chinese subjects.
Bauer, RJ; Hu, P; Hu, Y; Jiang, J; Kubitza, D; Meng, L; Mueck, W; Yang, J; Zhang, J, 2010
)
2.04
"Rivaroxaban is an oral Xa inhibitor which shows a significantly better efficacy compared to enoxaparin and no difference in side effects."( [Oral prevention of thromboembolism with rivaroxaban and dabigatran: are the newly approved drugs innovations in orthopaedic and trauma surgery? ].
Gogarten, W; Pauschert, R; Quante, M, 2010
)
1.35
"Rivaroxaban is an oral direct factor Xa inhibitor in advanced development as an alternative to warfarin for the prevention and treatment of thromboembolic disorders."( Rivaroxaban-once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation: rationale and design of the ROCKET AF study.
, 2010
)
2.52
"Rivaroxaban is a small-molecule, direct factor Xa inhibitor that is under investigation for the prevention and treatment of venous and arterial thrombosis. "( Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban.
Mousa, SA, 2010
)
2.05
"Rivaroxaban is a cost-effective alternative to enoxaparin for VTE prophylaxis in patients undergoing THR and TKR."( Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous thromboembolism in Canada.
Ananthapavan, J; Diamantopoulos, A; Forster, F; Lees, M; McDonald, H; Wells, PS, 2010
)
1.4
"Rivaroxaban is a newly developed oral medicine that direct inhibits factor Xa for the prevention and treatment of thromboembolic disorders. "( Rivaroxaban versus enoxaparin for thromboprophylaxis after total hip or knee arthroplasty: a meta-analysis of randomized controlled trials.
Cao, YB; Jiang, YY; Shen, H; Zhang, JD, 2010
)
3.25
"Rivaroxaban is an oral direct factor Xa inhibitor developed for prophylaxis and treatment of thromboembolic disorders. "( Effects of the oral, direct factor Xa inhibitor rivaroxaban on commonly used coagulation assays.
Baghaei, F; Fagerberg Blixter, I; Gustafsson, KM; Hillarp, A; Lindahl, TL; Sten-Linder, M; Stigendal, L; Strandberg, K, 2011
)
2.07
"Rivaroxaban is a novel Xa inhibitor with an encouraging anti-thrombosis effect. "( A systematic review of rivaroxaban versus enoxaparin in the prevention of venous thromboembolism after hip or knee replacement.
Banghua, L; Jin, C; Turun, S; Ying, N; Yuan, Y; Zhenhui, L, 2011
)
2.12
"Rivaroxaban is a safe and effective choice of thromboprophylactic agent following lower limb arthroplasty surgery. "( Safety and efficacy of rivaroxaban for thromboprophylaxis following lower limb surgery: an update.
Giannoudis, PV; Goff, T; Kontakis, G, 2011
)
2.12
"Rivaroxaban was shown to be a substrate for, but not an inhibitor of, P-gp."( In vitro and in vivo P-glycoprotein transport characteristics of rivaroxaban.
Buetehorn, U; Gnoth, MJ; Muenster, U; Sandmann, S; Schwarz, T, 2011
)
1.33
"Rivaroxaban is an oral, direct Factor Xa inhibitor approved in the European Union and several other countries for the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery and is in advanced clinical development for the treatment of thromboembolic disorders. "( Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.
Burghaus, R; Coboeken, K; Gaub, T; Kuepfer, L; Lippert, J; Mueck, W; Sensse, A; Siegmund, HU; Weiss, W, 2011
)
2.08
"Rivaroxaban is a substrate of CYP3A4 and P-glycoprotein and therefore not recommended for concomitant use with strong inhibitors of both pathways, e.g."( Pharmacodynamic and pharmacokinetic basics of rivaroxaban.
Kreutz, R, 2012
)
1.36
"Rivaroxaban is an oral, direct Factor Xa inhibitor, which is at an advanced stage of clinical development for prevention and treatment of thromboembolic disorders. "( Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention.
Agnelli, G; Decousus, H; Lensing, AW; Misselwitz, F; Mueck, W; Prandoni, P, 2011
)
3.25
"Rivaroxaban is an oral, direct factor Xa inhibitor. "( Evaluation of the anti-factor Xa chromogenic assay for the measurement of rivaroxaban plasma concentrations using calibrators and controls.
Contant, G; Gourmelin, Y; Guinet, C; Le Flem, L; Martinoli, JL; Perzborn, E; Rohde, G; Samama, MM; Spiro, TE, 2012
)
2.05
"Rivaroxaban is a safe and effective method of providing this thromboprophylaxis."( Oral thromboprophylaxis in pelvic trauma: a standardized protocol.
Cid, A; Godoy Monzon, D; Iserson, KV; Vazquez, JA, 2012
)
1.1
"Rivaroxaban is an oral Factor Xa inhibitor. "( Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.
Berglund, EG; Booth, BP; Bullock, J; Grillo, JA; Huang, SM; Lesko, LJ; Lu, M; Pang, KS; Rahman, A; Robie-Suh, K; Zhang, L; Zhao, P, 2012
)
2.02
"Rivaroxaban is a potent and specific direct inhibitor of coagulation factor Xa. "( Effect of the factor Xa inhibitor rivaroxaban on arterial thrombosis in wild-type and apolipoprotein E-deficient mice.
Dressel, T; Konstantinides, S; Schäfer, K; Wagner, NM, 2012
)
2.1
"Rivaroxaban is an oral, direct factor Xa inhibitor that has advantages over traditional VTE therapies, including minimal drug and food interactions and no requirement for routine coagulation monitoring."( The use of rivaroxaban for short- and long-term treatment of venous thromboembolism.
Cohen, AT; Dobromirski, M, 2012
)
1.49
"Rivaroxaban is a direct factor Xa inhibitor, which can be monitored by anti-factor Xa chromogenic assays. "( Accurate determination of rivaroxaban levels requires different calibrator sets but not addition of antithrombin.
Herth, N; Hesse, C; Lindhoff-Last, E; Mani, H; Perzborn, E; Rohde, G; Schwers, S; Stratmann, G, 2012
)
2.12
"Rivaroxaban is an oral direct factor Xa inhibitor, which was shown to be effective for the prevention of venous thromboembolism after elective hip and knee arthroplasty in the RECORD study program."( Rationale and design of XAMOS: noninterventional study of rivaroxaban for prophylaxis of venous thromboembolism after major hip and knee surgery.
Haas, S; Jamal, W; Kreutz, R; Lassen, MR; Mantovani, L; Schmidt, AC; Turpie, AG, 2012
)
1.34
"Rivaroxaban (Xarelto(®)) is a new anticoagulant for the prevention and treatment of thromboembolic disorders. "( [Rivaroxaban in the prevention and treatment of thromboembolic disorders].
Bode, C; Helbing, T; Moser, M, 2012
)
2.73
"Rivaroxaban (XARELTO(®)) is a novel anticoagulant with specific ability to inhibit factor Xa, a serine endopeptidase, which plays a key role in coagulation."( The effects of direct factor Xa inhibitor (Rivaroxaban) on the human osteoblastic cell line SaOS2.
Chechik, O; Dolkart, O; Gigi, R; Katzburg, S; Salai, M; Somjen, D; Stern, N, 2012
)
1.36
"Rivaroxaban is a novel factor 10a inhibitor, where hepatic metabolism and renal clearance account for its overall disposition. "( Absence of both MDR1 (ABCB1) and breast cancer resistance protein (ABCG2) transporters significantly alters rivaroxaban disposition and central nervous system entry.
Gong, IY; Kim, RB; Mansell, SE, 2013
)
2.05
"Rivaroxaban is an attractive alternative, but the true picture of this novel compound in atrial fibrillation will only become available with more widespread use."( Rivaroxaban in atrial fibrillation.
Giorgi, MA; Miguel, LS, 2012
)
2.54
"Rivaroxaban is an oral anticoagulant that directly targets both free factor Xa and factor Xa in complex with its protein cofactor, factor Va, in the prothrombinase complex. "( Rivaroxaban delivery and reversal at a venous flow rate.
Haynes, LM; Mann, KG; Orfeo, T, 2012
)
3.26
"Rivaroxaban is a direct oral anticoagulant targeting factor Xa. "( [Questions--answers on the use of rivaroxaban for the treatment of venous thromboembolic disease].
Elias, A; Gaillard, C; Gouin, I; Nguyen, P; Ouvry, P; Pernod, G; Sié, P, 2012
)
2.1
"Rivaroxaban is an oral anticoagulant, currently licensed for use as a venous thromboembolism (VTE) prophylaxis, and recommended by the National Institute for Clinical Excellence (NICE) for all patients undergoing elective hip and knee replacement surgery in the UK. "( A case report describing a suspected rivaroxaban hypersensitivity reaction in a surgical patient.
Choudhry, M; Keys, G; Yates, J, 2013
)
2.11
"Rivaroxaban A (R) is an anticoagulant recently introduced in the clinical setting, which is a specific factor Xa inhibitor."( Rivaroxaban, a direct inhibitor of the coagulation factor Xa interferes with hormonal-induced physiological modulations in human female osteoblastic cell line SaSO2.
Dolkart, O; Gigi, R; Katzburg, S; Salai, M; Sharon, O; Somjen, D; Stern, N, 2013
)
2.55
"Rivaroxaban (BAY 59-7939) is an oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. "( Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban--an oral, direct factor Xa inhibitor--are not affected by aspirin.
Becka, M; Kubitza, D; Mueck, W; Zuehlsdorf, M, 2006
)
2.02
"Rivaroxaban (BAY 59-7939) is a novel, oral, direct factor Xa inhibitor in clinical development."( Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects.
Becka, M; Kubitza, D; Mueck, W; Zuehlsdorf, M, 2007
)
1.28
"Rivaroxaban (BAY 59-7939) is a novel, oral, direct Factor Xa inhibitor in clinical development for the prevention of thromboembolic disorders. "( Dose-escalation study of rivaroxaban (BAY 59-7939)--an oral, direct Factor Xa inhibitor--for the prevention of venous thromboembolism in patients undergoing total hip replacement.
Borris, LC; Dahl, OE; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F; Muehlhofer, E, 2007
)
2.09
"Oral rivaroxaban (BAY 597939) is a new, highly selective and potent direct factor-Xa (FXa) inhibitor with a predictable pharmacodynamic and pharmacokinetic profile and could therefore be an attractive antithrombotic drug."( Prevention and treatment of experimental thrombosis in rabbits with rivaroxaban (BAY 597939)--an oral, direct factor Xa inhibitor.
Biemond, BJ; Buetehorn, U; Büller, HR; Friederich, PW; Levi, M; Perzborn, E, 2007
)
1.03
"Rivaroxaban (BAY 59-7939) is an oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of venous thromboembolism (VTE). "( Rivaroxaban for thromboprophylaxis after orthopaedic surgery: pooled analysis of two studies.
Bauer, KA; Borris, L; Dahl, OE; Eriksson, BI; Fisher, WD; Gent, M; Haas, S; Homering, M; Huisman, MV; Kakkar, AK; Kälebo, P; Kwong, LM; Misselwitz, F; Turpie, AG, 2007
)
3.23
"Rivaroxaban (BAY 59-7939) is an oral direct factor Xa inhibitor currently under clinical development."( Treatment of proximal deep-vein thrombosis with the oral direct factor Xa inhibitor rivaroxaban (BAY 59-7939): the ODIXa-DVT (Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients With Acute Symptomatic Deep-Vein Thrombosis) study.
Agnelli, G; Gallus, A; Goldhaber, SZ; Haas, S; Huisman, MV; Hull, RD; Kakkar, AK; Misselwitz, F; Schellong, S, 2007
)
1.29
"Rivaroxaban (BAY 59-7939) is an oral, direct Factor Xa (FXa) inhibitor being developed for the prevention and treatment of thromboembolic disorders. "( Population model of the pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor xa inhibitor--in healthy subjects.
Becka, M; Kubitza, D; Mueck, W; Voith, B; Zuehlsdorf, M, 2007
)
2.02
"Rivaroxaban (BAY 59-7939) is an oral, direct factor Xa inhibitor in advanced development. "( Effects of the oral, direct factor xa inhibitor rivaroxaban on platelet-induced thrombin generation and prothrombinase activity.
Becka, M; Breddin, HK; Graff, J; Harder, S; Kubitza, D; Misselwitz, F; von Hentig, N, 2007
)
2.04
"Rivaroxaban (Xarelto) is a novel, oral, direct Factor Xa (FXa) inhibitor in late-stage development for the prevention and treatment of thromboembolic disorders. "( Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders.
Kubitza, D; Misselwitz, F; Perzborn, E, 2007
)
3.23
"Rivaroxaban (BAY 59-7939) is a novel, oral, direct Factor Xa inhibitor in advanced clinical development for the prevention and treatment of thromboembolic disorders. "( Randomized, double-blind, crossover study to investigate the effect of rivaroxaban on QT-interval prolongation.
Becka, M; Kubitza, D; Mueck, W, 2008
)
2.02
"Rivaroxaban is an oral direct Factor Xa (FXa) inhibitor in clinical development for the prevention and treatment of thromboembolic disorders."( Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery.
Bauer, KA; Borris, L; Dahl, OE; Eriksson, BI; Fisher, WD; Gent, M; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Kwong, LM; Misselwitz, F; Mueck, W; Turpie, AG, 2008
)
1.32
"Rivaroxaban is a small molecule, direct Factor Xa inhibitor and may be a potentially attractive alternative to vitamin K antagonists. "( Rivaroxaban, an oral direct factor Xa inhibitor.
Califf, RM; Fox, KA; Mahaffey, KW; Patel, MR; Piccini, JP, 2008
)
3.23

Effects

Rivaroxaban has a 50% probability of being cost-saving compared with VKAs and would increase a patient's quality of life when non-health care costs are taken into account. The drug has a positive anticoagulation effect but leads to increases in both postoperative blood loss and wound complications in patients.

Rivaro has been shown to be efficacious for treatment of venous thromboembolism in adults. Rivaroxaban has been documented as a low-cost, easily controlled option compared with standard therapy.

ExcerptReferenceRelevance
"Rivaroxaban has a stronger effect on TG than apixaban."( Influence of direct oral anticoagulants on thrombin generation on Ceveron TGA.
Behrendt, LC; Bönigk, H; Franke, D; Metze, M; Petros, S; Pfrepper, C; Siegemund, A; Siegemund, T, 2022
)
1.44
"Rivaroxaban, has a short half-life."( Patient adherence to rivaroxaban in deep vein thrombosis, a cohort study in Switzerland: quantitative results.
Alatri, A; Bugnon, O; Dotta-Celio, J; Locatelli, I; Mazzolai, L; Salvi, M; Schneider, MP, 2019
)
1.55
"Rivaroxaban has a 50% probability of being cost-saving compared with VKAs and would increase a patient's quality of life when non-health care costs such as productivity loss and informal care costs are taken into account."( Health economic evaluation of rivaroxaban in elective cardioversion of atrial fibrillation.
de Jong, LA; Jacobs, MS; Postma, MJ; Tieleman, RG; van Hulst, M, 2018
)
1.49
"Rivaroxaban has an improved safety profile in patients with moderate renal dysfunction due to a significantly lower incidence of major bleeding."( Effectiveness and Safety of Rivaroxaban Compared to Acenocumarol after Infrainguinal Surgical Revascularization.
Almeida, R; Antunes, I; Ferreira, V; Freixo, C; Gonçalves, J; Martins, J; Mendes, D; Teixeira, G; Veiga, C, 2019
)
1.53
"Rivaroxaban has a short half-life, undergoes a dual mode of elimination (hepatic and renal), and is a substrate for P-glycoprotein."( Rivaroxaban: practical considerations for ensuring safety and efficacy.
Dager, WE; Fanikos, J; Gulseth, MP; Nutescu, EA; Smythe, MA; Spinler, SA; Wittkowsky, AK, 2013
)
2.55
"Rivaroxaban, which has a rapid onset of action, targets free and clot-bound Factor Xa and Factor Xa in the prothrombinase complex."( Pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor.
Kreutz, R, 2014
)
1.39
"Rivaroxaban has a positive anticoagulation effect but leads to increases in both postoperative blood loss and wound complications in patients."( Administering aspirin, rivaroxaban and low-molecular-weight heparin to prevent deep venous thrombosis after total knee arthroplasty.
Sun, K; Tian, S; Wang, Y; Zou, Y, 2014
)
1.43
"Rivaroxaban also has a lower potential for drug-drug and food-drug interactions compared with warfarin; however, co-administration with strong inhibitors of both cytochrome P450 3A4 and P-glycoprotein is not recommended."( Rivaroxaban for the treatment and prevention of thromboembolic disease.
Antoniou, S, 2015
)
2.58
"Rivaroxaban has a higher incidence of bleeding complication and further clinical trials are required to be conducted to assess the safety of rivaroxaban in clinical."( [Case-control study on three antithrombotic agents for the prevention of venous thromboembolism after unilateral total knee arthroplasty].
Lu, JH; Lu, N; Miao, SG; Yang, Y; Zhang, XG, 2015
)
1.14
"Rivaroxaban has a high rate of bleeding complications when used alone in TKA patients."( The Efficacy of Combined Use of Rivaroxaban and Tranexamic Acid on Blood Conservation in Minimally Invasive Total Knee Arthroplasty a Double-Blind Randomized, Controlled Trial.
Chen, B; Huang, CC; Kuo, FC; Lin, PC; Wang, JW; Yen, SH, 2017
)
1.46
"Rivaroxaban has a flat dose-dependent anticoagulant response with a wide therapeutic window and low potential for drug-drug and drug-food interactions."( Factor Xa inhibitors--new anticoagulants for secondary haemostasis.
Perzborn, E, 2009
)
1.07
"Rivaroxaban has a dual mode of excretion with the renal route accounting for one-third of the overall elimination of unchanged active drug."( Pharmacodynamic and pharmacokinetic basics of rivaroxaban.
Kreutz, R, 2012
)
1.36
"Rivaroxaban has been stopped prematurely in 21.6% of patients."( Rivaroxaban in Patients With Atrial Fibrillation Who Underwent Percutaneous Coronary Intervention in Clinical Practice.
Bekeredjian, R; Claas, C; Cuneo, A; Hailer, B; Hennersdorf, M; Hertting, K; Hobbach, HP; Lanzer, P; Liebetrau, C; Mudra, H; Riemer, T; Ritter, O; Scholtz, W; Schwefer, M; Schwimmbeck, PL; Thiele, H; Toelg, R; Wienbergen, H; Zahn, R; Zeymer, U, 2023
)
3.07
"Rivaroxaban has been studied in patients with varying degrees of renal impairment, and this review summarizes current knowledge supporting its use in patients with severe renal impairment (creatinine clearance [CrCl] of 15 to < 30 mL/min) for the prevention, treatment, or prophylaxis of VTE."( Updated Renal Dosage Recommendations for Rivaroxaban in Patients Experiencing or at Risk of Thromboembolic Disease.
Barnathan, ES; Haskell, L; Moore, KT; Volkl, AA, 2023
)
1.9
"Rivaroxaban has been shown to be efficacious for treatment of venous thromboembolism in adults, and has a reduced risk of bleeding compared with standard anticoagulants. "( Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies.
Becka, M; Beyer-Westendorf, J; Connor, P; Grangl, G; Halton, J; Holzhauer, S; Kapsa, S; Kenet, G; Kubitza, D; Kumar, R; Lensing, AWA; Male, C; Martinelli, I; Molinari, AC; Monagle, P; Nowak-Göttl, U; Pap, AF; Prins, MH; Robertson, J; Samochatova, E; Santamaría, A; Saracco, P; Simioni, P; Thelen, K; Twomey, T; Willmann, S; Young, G, 2019
)
2.28
"Rivaroxaban has been investigated in the EINSTEIN-Jr program for the treatment of acute venous thromboembolism (VTE) in children aged 0 to 18 years and in the UNIVERSE program for thromboprophylaxis in children aged 2 to 8 years with congenital heart disease after Fontan-procedure. "( Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically-based pharmacokinetic predictions.
Coboeken, K; Drenth, HJ; Ince, I; Kubitza, D; Lensing, AWA; Lippert, J; Mayer, H; Mesic, E; Mück, W; Thelen, K; Willmann, S; Yang, H; Zhang, Y; Zhu, P, 2021
)
2.33
"Rivaroxaban has been documented as a low-cost, easily controlled option compared with standard therapy. "( Rivaroxaban Used in the Treatment Patients With Gynecologic Cancer and Venous Thromboembolism: The Experience of Instituto Nacional de Câncer-Rio de Janeiro, Brazil.
Araujo, MLC; Bergmann, A; de Morais E Coura, CP; Renni, MJP; Trugilho, I, 2017
)
3.34
"Rivaroxaban has been used only after the initial treatment with heparin in the available studies."( Is it safe to treat cerebral venous thrombosis with oral rivaroxaban without heparin? A preliminary study from 20 patients.
Akhtar, S; Kumar, P; Muthukalathi, K; Muthukumar, K; Shankar Iyer, R; Tcr, R, 2018
)
1.45
"Rivaroxaban has been approved as an antithrombotic agent for prevention of venous thromboembolism with specific indications. "( In vitro assessment, using thrombin generation, of the applicability of prothrombin complex concentrate as an antidote for Rivaroxaban.
Brinkman, HJ; de Laat, B; Dinkelaar, J; Leyte, A; Molenaar, PJ; Ninivaggi, M, 2013
)
2.04
"Rivaroxaban has been approved for clinical use in several thromboembolic disorders."( Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2014
)
1.37
"Rivaroxaban recently has been approved for the treatment of venous thromboembolism (VTE)."( Safe-dose thrombolysis plus rivaroxaban for moderate and severe pulmonary embolism: drip, drug, and discharge.
Bay, C; Schwartz, F; Sharifi, M; Skrocki, L, 2014
)
1.42
"Rivaroxaban has shown similar efficacy and a similar or better safety profile compared with standard treatment for several venous and arterial indications, including venous thromboembolism, nonvalvular atrial fibrillation, and acute coronary syndrome."( Management of rivaroxaban in relation to bodyweight and body mass index.
Uprichard, J, 2016
)
1.52
"Rivaroxaban has been shown to reduce overall death from cardiovascular causes in patients with recent acute coronary syndrome. "( Rivaroxaban, a factor Xa inhibitor, induces the secondary prevention of cardiovascular events after myocardial ischemia reperfusion injury in mice.
Goto, M; Idemoto, Y; Imaizumi, S; Miura, S; Saku, K; Suematsu, Y; Takata, K; Uehara, Y, 2016
)
3.32
"Rivaroxaban has been shown to have similar efficacy but less major bleeding than warfarin in randomized trials of patients experiencing venous thromboembolism (VTE). "( Healthcare costs associated with rivaroxaban or warfarin use for the treatment of venous thromboembolism.
Baugh, C; Coleman, CI; Crivera, C; Lu, L; Milentijevic, D; Nelson, WW; Wang, SW, 2017
)
2.18
"Rivaroxaban has been shown to have tolerable adverse effects and a low potential for drug-drug or drug-food interactions."( Rivaroxaban: an oral direct factor Xa inhibitor for the prevention of thromboembolism.
Chen, T; Lam, S,
)
2.3
"Rivaroxaban has been recommended for routine use as a thromboprophylactic agent in patients undergoing lower-limb arthroplasty. "( Return to theatre following total hip and knee replacement, before and after the introduction of rivaroxaban: a retrospective cohort study.
Jensen, CD; Muller, SD; Partington, PF; Reed, MR; Steval, A, 2011
)
2.03
"Rivaroxaban has been extensively studied worldwide in 12,729 patients in the Regulation of Coagulation in Major Orthopedic Surgery Reducing the Risk of DVT and PE (RECORD) program."( Therapeutic potential of rivaroxaban in the prevention of venous thromboembolism following hip and knee replacement surgery: a review of clinical trial data.
Kwong, LM, 2011
)
1.39
"Rivaroxaban however has been granted authorisation by the FDA for the thromboprophylaxis after surgery for total hip or knee surgery."( [Pharmacologic heterogeneity of new anticoagulants].
Combe, S; Conard, J; Flaujac, C; Horellou, MH; Samamaa, MM, 2011
)
1.09
"Rivaroxaban has been found to be noninferior to warfarin for preventing stroke or systemic embolism in patients with high-risk atrial fibrillation (AF) and is associated with a lower rate of intracranial hemorrhage. "( Cost-effectiveness of rivaroxaban compared to warfarin for stroke prevention in atrial fibrillation.
Anglade, MW; Coleman, CI; Kluger, J; Lee, S; Pham, D; Pisacane, R, 2012
)
2.14
"Rivaroxaban has been tested in trials to prevent and treat venous thromboembolism, and the results were indicative of a safe, effective and therapeutic pharmacological profile."( Rivaroxaban.
Kakar, P; Lip, GY; Watson, T, 2007
)
2.5

Actions

Rivaroxaban users had lower per patient per month (PPPM) clinical event costs compared with aspirin users. Patients had lower risk for stroke overall (hazard ratio [HR] 0.82; 95% confidence interval [CI], 0.76-0.88) and for minor (NIHSS 1 to <5; HR, 0.83;  95% CI,. 0.74-1.93) and severe stroke. Rivaroxabans did not increase either intracranial hemorrhage or fatal bleeding.

ExcerptReferenceRelevance
"Rivaroxaban patients had lower risk for stroke overall (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.76-0.88) and for minor (NIHSS 1 to <5; HR, 0.83; 95% CI, 0.74-0.93), moderate (NIHSS 5 to <16; HR, 0.88; 95% CI, 0.78-0.99), and severe stroke (NIHSS 16 to 42; HR, 0.44; 95% CI, 0.22-0.91)."( Risk of Stroke Outcomes in Atrial Fibrillation Patients Treated with Rivaroxaban and Warfarin.
Alberts, MJ; Chen, YW; Connolly, N; Kogan, E; Lin, JH; Milentijevic, D; Shrivastava, S; Sjoeland, E, 2021
)
1.58
"Rivaroxaban may lower the rate of stroke or systemic embolism vs. "( Effectiveness and safety of rivaroxaban vs. warfarin in non-valvular atrial fibrillation patients with a non-sex-related CHA2DS2-VASc score of 1.
Baker, WL; Bunz, TJ; Coleman, CI; Eriksson, D; Sood, NA; Turpie, AGG, 2019
)
2.25
"Rivaroxaban users had lower per patient per month (PPPM) clinical event costs compared with aspirin users ($123, $243, and $381 for rivaroxaban 10 mg, rivaroxaban 20 mg, and aspirin, respectively). "( Health-care Cost Impact of Continued Anticoagulation With Rivaroxaban vs Aspirin for Prevention of Recurrent Symptomatic VTE in the EINSTEIN-CHOICE Trial Population.
Ashton, V; Beyer-Westendorf, J; Crivera, C; Haskell, L; Laliberté, F; Lefebvre, P; Lejeune, D; Lensing, AWA; Levitan, B; Prandoni, P; Prins, MH; Schein, J; Wells, PS; Xiao, Y; Yuan, Z; Zhao, Q, 2018
)
2.17
"Rivaroxaban also did not increase either intracranial hemorrhage or fatal bleeding."( Usefulness of Rivaroxaban for Secondary Prevention of Acute Coronary Syndrome in Patients With History of Congestive Heart Failure (from the ATLAS-ACS-2 TIMI-51 Trial).
Bhatt, DL; Bode, C; Braunwald, E; Burton, P; Cohen, M; Daaboul, Y; Gibson, CM; Korjian, S; Mi, M; Plotnikov, AN; Verheugt, FWA, 2018
)
1.56
"Rivaroxaban alone did not produce any additional benefit compared with aspirin."( Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS.
Anand, SS; Bhagirath, VC; Eikelboom, JW, 2018
)
1.62
"Rivaroxaban had a lower stroke/SE rate (hazard ratio = 0.65, 0.52-0.81) and higher MB rate (hazard ratio = 1.18, 1.08-1.30) versus warfarin."( Effectiveness and safety of oral anticoagulants in older adults with non-valvular atrial fibrillation and heart failure.
Amin, A; Dhamane, A; Di Fusco, M; Friend, K; Garcia Reeves, AB; Keshishian, A; Li, X; Luo, X; Mardekian, J; Nadkarni, A; Pan, X; Rosenblatt, L; Yuce, H, 2019
)
1.24
"Rivaroxaban has a lower potential for drug interactions compared with warfarin."( Rivaroxaban: practical considerations for ensuring safety and efficacy.
Dager, WE; Fanikos, J; Gulseth, MP; Nutescu, EA; Smythe, MA; Spinler, SA; Wittkowsky, AK, 2013
)
2.55
"Rivaroxaban does not inhibit cytochrome P450 enzymes or known drug transporter systems and, because rivaroxaban has multiple elimination pathways, it has no clinically relevant interactions with most commonly prescribed medications."( Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2014
)
1.37
"Rivaroxaban does not increase the risk of hidden blood loss for TKA when compared with enoxaparin, but enoxaparin can increase the risk of dominant blood."( [Comparison of rivaroxaban and enoxaparin on blood loss after total knee arthroplasty].
Jing, J; Li, J; Yao, Y; Zhan, J; Zhou, Y, 2014
)
2.2
"Rivaroxaban group showed lower modified Rankin Scale at discharge relative to warfarin, and the difference between modified Rankin Scale before admission and at discharge was smaller in rivaroxaban than in warfarin (median: 1 versus 3; P=0.047)."( Characteristics of intracerebral hemorrhage during rivaroxaban treatment: comparison with those during warfarin.
Baba, Y; Hagii, J; Hitomi, H; Iwata, M; Kamada, T; Matsumoto, S; Metoki, N; Okumura, K; Osanai, T; Saito, S; Sasaki, S; Seino, S; Shiroto, H; Takahashi, K; Tomita, H; Uchizawa, T; Yasujima, M, 2014
)
1.38
"Rivaroxaban also has a lower potential for drug-drug and food-drug interactions compared with warfarin; however, co-administration with strong inhibitors of both cytochrome P450 3A4 and P-glycoprotein is not recommended."( Rivaroxaban for the treatment and prevention of thromboembolic disease.
Antoniou, S, 2015
)
2.58
"Rivaroxaban displays stronger inhibition on thrombin generation and PAg than dabigatran."( An in-vitro evaluation of direct thrombin inhibitor and factor Xa inhibitor on tissue factor-induced thrombin generation and platelet aggregation: a comparison of dabigatran and rivaroxaban.
Huang, B; Shao, X; Wan, H; Wang, J; Wu, S; Yang, Y; Zhang, H; Zhou, Z; Zhu, J, 2016
)
1.35
"Rivaroxaban did not increase the hematoma volume relative to that observed for vehicle, and improved survival rate 7 days after ICH induction compared with warfarin."( In Models of Intracerebral Hemorrhage, Rivaroxaban is Superior to Warfarin to Limit Blood Brain Barrier Disruption and Hematoma Expansion.
Egashira, Y; Hara, H; Iwama, T; Ono, Y; Sawada, S; Shimazawa, M; Takagi, T; Tsuruma, K, 2017
)
1.45
"Rivaroxaban did not cause platelet activation or aggregation in the presence of HIT antibodies, unlike UFH and enoxaparin, suggesting that rivaroxaban does not cross-react with HIT antibodies."( Rivaroxaban--an oral, direct Factor Xa inhibitor--has potential for the management of patients with heparin-induced thrombocytopenia.
Bakhos, M; Hoppensteadt, D; Iqbal, O; Jeske, WP; Maddineni, J; Messmore, HL; Prechel, M; Walenga, JM, 2008
)
2.51
"Rivaroxaban did not increase intra- or post-operative bleeding in surgical wounds."( Oral thromboprophylaxis in pelvic trauma: a standardized protocol.
Cid, A; Godoy Monzon, D; Iserson, KV; Vazquez, JA, 2012
)
1.1

Treatment

Treatment with rivaroxaban 20 mg once daily was associated with statistically significant increases in ICH and major extracranial bleeding, including major gastrointestinal bleeding. Treatment attenuated neuroinflammation, blood-brain barrier dysfunction, memory deficits, and amyloid-β deposition through PAR-1/PAR-2 inhibition in the AD + CAA mice model.

ExcerptReferenceRelevance
"Rivaroxaban treatment for 20 weeks (n = 89) resulted in a significant improvement of post-ischaemic forearm blood flow (3.6 ± 4.7 vs 1.0 ± 5.2 ml/100 ml, p = 0.004), a numerically increased skin blood flow and reduced soluble P-Selectin plasma level vs aspirin. "( Rivaroxaban compared with low-dose aspirin in individuals with type 2 diabetes and high cardiovascular risk: a randomised trial to assess effects on endothelial function, platelet activation and vascular biomarkers.
Birkenfeld, AL; Bornstein, SR; Hanefeld, M; Henkel, E; Matschke, JB; Pistrosch, F; Schipp, B; Schipp, D; Sradnick, J; Weigmann, I, 2021
)
3.51
"Rivaroxaban treatment attenuated neuroinflammation, blood-brain barrier dysfunction, memory deficits, and amyloid-β deposition through PAR-1/PAR-2 inhibition in the AD + CAA mice model compared with warfarin and no-treatment groups."( Protective Effect of Rivaroxaban Against Amyloid Pathology and Neuroinflammation Through Inhibiting PAR-1 and PAR-2 in Alzheimer's Disease Mice.
Abe, K; Bian, Y; Bian, Z; Feng, T; Fukui, Y; Hu, X; Liu, X; Morihara, R; Nakano, Y; Sun, H; Tadokoro, K; Takemoto, M; Yamashita, T; Yu, H; Yunoki, T, 2022
)
2.48
"The rivaroxaban treatment may provide the most favorable prognosis due to the prevention of recurrent stroke in AF, reducing the rate of kidney disease progression, and slowing vascular atherosclerosis."( [Modern issues of improving the prognosis in patients with atrial fibrillation after ischemic stroke].
Arablinsky, AV; Butorova, VN; Kochetkova, AI; Ostroumova, OD; Ostroumova, TM, 2022
)
1.2
"Rivaroxaban was used for treatment of acute VTE in 64 patients. "( Real world experience of efficacy and safety of rivaroxaban in paediatric venous thromboembolism.
Hassan, E; Motwani, J, 2023
)
2.61
"Rivaroxaban-treated Chinese NVAF patients will be recruited according to predetermined inclusion criteria."( Rationale and design of a prospective study evaluating population pharmacokinetics and pharmacodynamics of rivaroxaban in Chinese patients with non-valvular atrial fibrillation.
Ding, HY; Liu, XQ; Ma, CL; Yan, MM; Zhang, YF; Zhong, MK, 2022
)
1.66
"Rivaroxaban treatment of mice for 7 days markedly diminished mature leukocytes in the BM."( Rivaroxaban attenuates neutrophil maturation in the bone marrow niche.
Döring, M; Fender, AC; Flögel, U; Gerfer, S; Gorressen, S; Grandoch, M; Heitmeier, S; Helten, C; Jung, C; Kelm, M; Polzin, A; Schneckmann, R, 2023
)
3.07
"Rivaroxaban treatment yielded significantly less HRU and total medical costs, with similar total healthcare costs between groups."( Rivaroxaban versus warfarin treatment among morbidly obese patients with venous thromboembolism: Comparative effectiveness, safety, and costs.
Ashton, V; Chen, YW; Peterson, ED; Spyropoulos, AC; Wu, B, 2019
)
2.68
"Rivaroxaban treatment was associated with a lower risk of PTS when compared to enoxaparin/warfarin; RVT however, was not a mediator in the association between PTS and type of treatment."( Low prevalence of Post-thrombotic syndrome in patients treated with rivaroxaban.
Annichino-Bizzacchi, JM; Bittar, LF; Colella, MP; de Moraes Martinelli, B; de Oliveira, LFG; de Paula, EV; Ferreira, T; Huber, SC; Junior, AL; Mello, TT; Menezes, FH; Montalvão, S; Orsi, FA; Rielli, G; Sodre, LR; Yamaguti-Hayakawa, GG, 2020
)
1.51
"Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. "( Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.
Amedro, P; Bajolle, F; Berkowitz, SD; Beyer-Westendorf, J; Chan, AKC; Connor, P; Hege, K; Holzhauer, S; Hooimeijer, HL; Kenet, G; Kubitza, D; Kumar, R; Lensing, AWA; Male, C; Martinelli, I; Massicotte, MP; Monagle, P; Nurmeev, I; Palumbo, JS; Price, V; Prins, MH; Santamaría, A; Schmidt, S; Smith, WT; Thelen, K; Torres, M; Willmann, S; Young, G, 2020
)
3.44
"Rivaroxaban treatment discontinuation occurred in a total of 574 patients during follow-up (11.0/100 patient-years in Kaplan-Meier analysis) and 426 patient died (all-cause mortality 6.3/100 pt."( 5-year outcomes from rivaroxaban therapy in atrial fibrillation: Results from the Dresden NOAC Registry.
Beyer-Westendorf, J; Marten, S; Naue, C; Tittl, L, 2021
)
1.66
"In rivaroxaban-treated patients"( Pharmacokinetics of Direct Oral Anticoagulants in Emergency Situations: Results of the Prospective Observational RADOA-Registry.
Beyer-Westendorf, J; Birschmann, I; Greinacher, A; Grottke, O; Herrmann, E; Konstantinides, S; Kuhn, J; Lindau, S; Lindhoff-Last, E; Lucks, J; Meybohm, P; Nowak-Göttl, U; Schellong, S; Sümnig, A; von Heymann, C; Zydek, B, 2022
)
1.24
"Rivaroxaban 20mg treatment significantly alters ROTEM® and CoaguChek® XS parameters. "( Impact of rivaroxaban on point-of-care assays.
Alberio, L; Angelillo-Scherrer, A; Asmis, LM; Fontana, P; Korte, W; Mendez, A; Nagler, M; Schmid, P; Stricker, H; Studt, JD; Tsakiris, DA; Wuillemin, WA, 2017
)
2.3
"Rivaroxaban treatment of patients with venous thromboembolism results in health gains and cost savings compared to LMWH/VKA therapy. "( Cost-effectiveness analysis of rivaroxaban for treatment and secondary prevention of venous thromboembolism in the Netherlands.
Giesen, EBW; Heemstra, HE; Heisen, M; Postma, MJ; Treur, MJ, 2017
)
2.18
"rivaroxaban for the treatment of US Medicare NVAF patients."( Cost-effectiveness analysis of dabigatran versus rivaroxaban for stroke prevention in patients with non-valvular atrial fibrillation using real-world evidence in elderly US Medicare beneficiaries.
Deger, KA; Gandhi, P; Kansal, AR; Peng, S; Qiao, N; Ustyugova, A; Wang, C, 2018
)
1.46
"Rivaroxaban-treated rats were less susceptible to EAE compared to the untreated control group."( Rivaroxaban ameliorates disease course in an animal model of multiple sclerosis.
Eichler, S; Göbel, K; Herrmann, AM; Kleinschnitz, C; Merker, M; Meuth, SG; Wiendl, H, 2017
)
2.62
"Rivaroxaban-treated NVAF patients with diagnosed renal dysfunction had a significantly lower stroke rate compared to warfarin-treated patients. "( Evaluation of clinical outcomes among nonvalvular atrial fibrillation patients treated with rivaroxaban or warfarin, stratified by renal function
.
Ashton, V; Berger, JS; Brown, K; Crivera, C; Haskell, L; Laliberté, F; Lefebvre, P; Schein, J; Weir, MR, 2018
)
2.14
"Rivaroxaban-treated patients had a lower rate of PTS (45%: 95% confidence interval [CI] 37 to 52) compared to those treated with warfarin (59%: 95% CI 51 to 66, absolute risk difference 14%: 95% CI 3 to 25, odds ratio (OR) 0.6, P = .01)."( Rivaroxaban versus warfarin for the prevention of post-thrombotic syndrome.
Dahm, A; Ghanima, W; Jelsness-Jørgensen, LP; Sandset, PM; Utne, KK; Wik, HS, 2018
)
2.64
"Rivaroxaban treatment post-THA/TKA discharge reduced the risk of 30 day readmission compared to non-anticoagulants. "( CMS hospital readmission reduction program and anticoagulants received following a total hip and knee arthroplasty discharge.
Bookhart, B; Coleman, CI; Kaatz, S; Laliberté, F; Lefebvre, P; Martin, S; Schein, J; Wynant, W; Xiao, Y, 2018
)
1.92
"The rivaroxaban VTE treatment pathway is a prospective cohort study of consecutive patients with objectively confirmed VTE between July 2015 and May 2017."( Utility of a Nurse-Led Pathway for Patients with Acute Venous Thromboembolism Discharged on Rivaroxaban: A Prospective Cohort Study.
Bennett, A; Brown, S; Chan, NC; Chunilal, S; Cummins, A; Epi, MC; Indran, T; Lim, MS; McQuilten, Z; Tran, H; Wood, E, 2019
)
1.21
"Rivaroxaban treatment decreased cardiac PAR2 levels and pro-inflammatory genes."( Rivaroxaban Suppresses the Progression of Ischemic Cardiomyopathy in a Murine Model of Diet-Induced Myocardial Infarction.
Chang, J; Inui, H; Kanno, K; Koseki, M; Liu, J; Masuda, D; Matsuda, H; Nakaoka, H; Nishida, M; Ohama, T; Okada, T; Sairyo, M; Sakata, Y; Yamashita, S; Zhu, Y, 2019
)
2.68
"Rivaroxaban treatment just after MI in Hypo E mice prevented the progression of ICM by attenuating cardiac remodeling, partially through the suppression of the PAR2-mediated inflammatory pathway."( Rivaroxaban Suppresses the Progression of Ischemic Cardiomyopathy in a Murine Model of Diet-Induced Myocardial Infarction.
Chang, J; Inui, H; Kanno, K; Koseki, M; Liu, J; Masuda, D; Matsuda, H; Nakaoka, H; Nishida, M; Ohama, T; Okada, T; Sairyo, M; Sakata, Y; Yamashita, S; Zhu, Y, 2019
)
3.4
"Rivaroxaban treatment vs aspirin."( Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation: Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial.
Arauz, A; Berkowitz, SD; Connolly, SJ; Coutts, SB; Czlonkowska, A; Eckstein, J; Endres, M; Epstein, AE; Gladstone, DJ; Haeusler, KG; Hankey, GJ; Hart, RG; Healey, JS; Karlinski, M; Kasner, SE; Lutsep, H; Mikulik, R; Molina, CA; Mundl, H; Ntaios, G; Pagola, J; Perera, K; Santo, G; Shuaib, A; Swaminathan, B; Toni, D; Uchiyama, S; Yang, X, 2019
)
2.27
"Rivaroxaban treatment was associated with fewer ischemic strokes and systemic embolisms (0.308 vs. "( Cost-effectiveness of rivaroxaban versus warfarin for stroke prevention in atrial fibrillation in the Belgian healthcare setting.
Asukai, Y; De Ruyck, M; Evers, T; Faes, P; Goethals, M; Kleintjens, J; Li, X; Rietzschel, ER; Saka, Ö; Simoens, S; Thijs, V; Vansieleghem, S, 2013
)
2.15
"Rivaroxaban treatment was associated with cost-savings for the treatment of deep vein thrombosis and was both cost-saving and more effective for the treatment of pulmonary embolism, compared with enoxaparin/warfarin."( Economic analysis of rivaroxaban for the treatment and long-term prevention of venous thromboembolism in Portugal.
Chatzitheofilou, I; Guillermin, AL; McLeod, E; Pereira, S; Santos, IF,
)
1.89
"Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients, particularly in reducing patient-reported anticoagulation burden."( Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial.
Bamber, L; Bauersachs, R; Cano, SJ; Erkens, P; Lensing, AW; Prins, MH; Wang, MY, 2015
)
2.11
"All rivaroxaban-treated patients (n = 134) in the database were well matched with four historical LMWH/warfarin-treated patients (n = 536). "( Rates of hospitalization among patients with deep vein thrombosis before and after the introduction of rivaroxaban.
Hollander, JE; Laliberté, F; Lefebvre, P; Merli, GJ; Olson, WH; Pollack, CV; Raut, MK, 2015
)
1.19
"Rivaroxaban treatment increased the duration of menstrual bleeding from median 5 (IQR 3.5-6.0) days before start of treatment to 6 (IQR 4.1-8.9) days (P<0.001)."( Abnormal uterine bleeding in VTE patients treated with rivaroxaban compared to vitamin K antagonists.
De Crem, N; Debaveye, B; Middeldorp, S; Peerlinck, K; Peetermans, M; Vanassche, T; Vanheule, K; Verhamme, P, 2015
)
1.39
"Rivaroxaban treatment discontinuation occurred in a total of 277 patients during follow-up (12.0/100 patient-years in Kaplan-Meier analysis)."( Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry.
Beyer-Westendorf, J; Hecker, J; Helmert, S; Keller, L; Marten, S; Michalski, F; Sahin, K; Tittl, L; Werth, S, 2016
)
1.45
"Rivaroxaban treatment would have resulted in 68 (95% CI, 2-134) more major bleeding events than would placebo (number needed to harm = 147)."( Long-term Anticoagulation With Rivaroxaban for Preventing Recurrent VTE: A Benefit-Risk Analysis of EINSTEIN-Extension.
Beyer-Westendorf, J; Bounameaux, H; Brighton, TA; Cohen, AT; Davidson, BL; Gebel, M; Katz, EG; Lensing, AWA; Levitan, B; Prandoni, P; Prins, MH; Raskob, GE; Wells, PS; Yuan, Z, 2016
)
1.44
"Rivaroxaban is a valuable treatment option for patients with biological prostheses, repaired mitral valves, or a tubular aortic graft in order to prevent thromboembolic complications."( Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis.
Acanfora, C; Acanfora, D; Casucci, G; Ciccone, MM; Dentamaro, I; Furgi, G; Incalzi, RA; Lanzillo, B; Longobardi, M; Scicchitano, P; Zito, A, 2016
)
2.14
"Rivaroxaban treatment predisposed to HMB (odds ratio [OR] 3.2, 95% [confidence interval] CI 1.4-8.2, p=0.007) and the interruption of anticoagulant treatment for 2-3days (OR 3.2, 95% CI 1.1-11.6, p=0.033)."( Heavy menstrual bleeding in women treated with rivaroxaban and vitamin K antagonists and the risk of recurrent venous thromboembolism.
Bryk, AH; Piróg, M; Plens, K; Undas, A, 2016
)
1.41
"Treatment with rivaroxaban was associated with a significantly lower incidence of RPD detected by VQ scan at 3-6 months compared to warfarin."( Incidence of residual perfusion defects by lung scintigraphy in patients treated with rivaroxaban compared with warfarin for acute pulmonary embolism.
Chunilal, S; Cummins, A; Jong, I; Lim, MS; Nandurkar, D; Tran, H, 2020
)
1.12
"Treatment with rivaroxaban is economically dominant over dalteparin in patients with cancer at risk for recurrent VTE in the Netherlands. "( Cost-effectiveness analysis and budget impact of rivaroxaban compared with dalteparin in patients with cancer at risk of recurrent venous thromboembolism.
de Jong, LA; Hulst, MV; Postma, MJ; van der Velden, AWG, 2020
)
1.17
"Treatment with rivaroxaban resulted in a decrease from baseline of thrombin-antithrombin complex versus placebo (-34.4 ug/L [95% CI: -69.4, 0.53] vs."( A pilot study of the effect of rivaroxaban in sickle cell anemia.
Ataga, KI; Cai, J; Elsherif, L; Key, NS; Matsui, N; Pawlinski, R; Wichlan, D; Wogu, AF, 2021
)
1.25
"Treatment with rivaroxaban could potentially become a novel therapeutic strategy for cardiac remodeling in patients with OSA and AF."( Factor Xa inhibition by rivaroxaban attenuates cardiac remodeling due to intermittent hypoxia.
Hayashi, T; Ijiri, Y; Imano, H; Izumi, Y; Kato, R; Nomura, A; Tanikawa, S; Yamaguchi, T; Yoshimura, F; Yoshiyama, M, 2018
)
1.13
"DVT treatment with rivaroxaban in routine clinical practice may reduce the cost per patient vs."( Healthcare resource use in XALIA: A subgroup analysis of a non-interventional study of rivaroxaban versus standard anticoagulation for deep vein thrombosis.
Ageno, W; Folkerts, K; Gebel, M; Haas, S; Kreutz, R; Mantovani, LG; Monje, D; Sahin, K; Schneider, J; Turpie, AGG; van Eickels, M; Zell, E, 2019
)
1.06
"Treatment with rivaroxaban cost $2,448 per-patient less and was associated with 0.0058 more QALYs compared with enoxaparin + VKA, making it a dominant economic strategy. "( Cost-effectiveness of rivaroxaban compared with enoxaparin plus a vitamin K antagonist for the treatment of venous thromboembolism.
Bookhart, BK; Coleman, CI; Huynh, L; Lefebvre, P; Mody, SH; Nutescu, EA; Tran, KN; Wang, ST; Zhuo, DY, 2014
)
1.07
"Treatment with rivaroxaban can be associated with severe, symptomatic liver injury. "( Symptomatic hepatocellular liver injury with hyperbilirubinemia in two patients treated with rivaroxaban.
Heim, M; Krähenbühl, S; Liakoni, E; Rätz Bravo, AE; Terracciano, L, 2014
)
0.97
"Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy, and the benefits of treatment were significantly greater."( Patient-reported treatment satisfaction with oral rivaroxaban versus standard therapy in the treatment of pulmonary embolism; results from the EINSTEIN PE trial.
Bamber, L; Bauersachs, R; Cano, SJ; Erkens, P; Lensing, AW; Prins, MH; Wang, MY, 2015
)
1.01
"The Treatment of Rivaroxaban versus Aspirin in Non-disabling Cerebrovascular Events (TRACE) study is a randomized, double-blind clinical trial with a target enrollment of 4400 patients. "( Treatment of Rivaroxaban versus Aspirin for Non-disabling Cerebrovascular Events (TRACE): study protocol for a randomized controlled trial.
Bai, Y; Han, J; Jiang, W; Liu, X; Yang, F; Zhang, G; Zhao, G, 2015
)
1.13
"Treatment with rivaroxaban may prevent more cerebrovascular events with an acceptable risk profile after TIA or minor stroke, compared with aspirin, thus helping to improve the outcome of the disease."( Treatment of Rivaroxaban versus Aspirin for Non-disabling Cerebrovascular Events (TRACE): study protocol for a randomized controlled trial.
Bai, Y; Han, J; Jiang, W; Liu, X; Yang, F; Zhang, G; Zhao, G, 2015
)
1.13
"Treatment with rivaroxaban was preferable over standard ACT with enoxaparin/warfarin with regards to the lysis of thrombus when duration of thrombosis did not exceed 10 days. "( [Ultrasound dynamics lysis apex thrombus as an objective criterion of effectiveness of anticoagulation therapy in venous thrombosis].
Agapov, AB; Kalinin, RE; Pshennikov, AS; Suchkov, IA, 2016
)
0.79
"Treatment with rivaroxaban 20 mg once daily was associated with statistically significant increases in ICH and major extracranial bleeding, including major gastrointestinal bleeding, compared with dabigatran 150 mg twice daily."( Stroke, Bleeding, and Mortality Risks in Elderly Medicare Beneficiaries Treated With Dabigatran or Rivaroxaban for Nonvalvular Atrial Fibrillation.
Chillarige, Y; Goulding, MR; Graham, DJ; Hsueh, YH; Izem, R; Kelman, JA; Liao, J; MaCurdy, TE; Mott, K; Reichman, ME; Southworth, MR; Wei, Y; Wernecke, M; Worrall, C, 2016
)
1

Toxicity

Short-term, low-dose rivaroxaban seems safe and effective for IDDVT treatment. The incidence of treatment-emergent adverse events in the safety population was similar between the two groups.

ExcerptReferenceRelevance
"Oral BAY 59--7939 in single doses up to 80 mg was safe and well tolerated and was not associated with an increased risk of bleeding compared with placebo."( Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor.
Becka, M; Kubitza, D; Voith, B; Wensing, G; Zuehlsdorf, M, 2005
)
0.33
"There is a clinical need for safe new oral anticoagulants."( Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects.
Becka, M; Kubitza, D; Voith, B; Wensing, G; Zuehlsdorf, M, 2005
)
0.33
" There was no dose-related increase in the frequency or severity of adverse events with BAY 59-7939."( Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects.
Becka, M; Kubitza, D; Voith, B; Wensing, G; Zuehlsdorf, M, 2005
)
0.33
"BAY 59-7939 was safe and well tolerated across the wide dose range studied, with predictable, dose-proportional pharmacokinetics and pharmacodynamics and no relevant accumulation beyond steady state."( Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects.
Becka, M; Kubitza, D; Voith, B; Wensing, G; Zuehlsdorf, M, 2005
)
0.33
" All treatments were well tolerated; drug-related adverse events were mild and transient."( Safety, tolerability, pharmacodynamics, and pharmacokinetics of rivaroxaban--an oral, direct factor Xa inhibitor--are not affected by aspirin.
Becka, M; Kubitza, D; Mueck, W; Zuehlsdorf, M, 2006
)
0.57
" Furthermore, there is no difference according to liver enzymes elevation and cardio-vascular adverse events."( [Rivaroxaban (Xarelto): efficacy and safety].
Arnaout, L; Bellamy, L; Chabbouh, T; Rosencher, N, 2008
)
1.26
" Rivaroxaban was well tolerated: there was a low incidence of treatment-emergent adverse events and all events were of mild intensity."( Safety, pharmacokinetics and pharmacodynamics of single doses of rivaroxaban - an oral, direct factor Xa inhibitor - in elderly Chinese subjects.
Bauer, RJ; Hu, P; Hu, Y; Jiang, J; Kubitza, D; Meng, L; Mueck, W; Yang, J; Zhang, J, 2010
)
1.51
"Rivaroxaban is a safe and effective choice of thromboprophylactic agent following lower limb arthroplasty surgery."( Safety and efficacy of rivaroxaban for thromboprophylaxis following lower limb surgery: an update.
Giannoudis, PV; Goff, T; Kontakis, G, 2011
)
2.12
"Dabigatran, an oral thrombin inhibitor, and rivaroxaban and apixaban, oral factor Xa inhibitors, have been found to be safe and effective in reducing stroke risk in patients with atrial fibrillation."( Comparative efficacy and safety of new oral anticoagulants in patients with atrial fibrillation.
Avorn, J; Choudhry, NK; Gagne, JJ; Patrick, AR; Schneeweiss, S, 2012
)
0.64
" There were no cases of venous thromboembolism or bleeding and no unexpected adverse events."( Initiation of rivaroxaban following low molecular weight heparin for thromboprophylaxis after total joint replacement: the Safe, Simple Transitions (SST) study.
Berkowitz, RD; Damaraju, CV; Jennings, LK; Mills, RM; Wildgoose, P, 2012
)
0.74
" The total incidence of adverse effect was 6% (3/50) in the observation group."( [Evaluation of efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in adult patients with primary bone tumor undergoing knee operation].
Guo, W; Tang, BQ; Tang, S; Tang, XD; Yan, TQ; Yang, RL, 2012
)
0.65
"With an excellent safety profile and a low incidence of adverse effects, Rivaroxaban is effective and safe in the prevention of VTE in adult patients with primary bone tumor undergoing knee operation."( [Evaluation of efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in adult patients with primary bone tumor undergoing knee operation].
Guo, W; Tang, BQ; Tang, S; Tang, XD; Yan, TQ; Yang, RL, 2012
)
0.88
" A comprehensive approach to education is needed for clinicians, patients, and technical support personnel involved in patient interactions to ensure safe use."( Rivaroxaban: practical considerations for ensuring safety and efficacy.
Dager, WE; Fanikos, J; Gulseth, MP; Nutescu, EA; Smythe, MA; Spinler, SA; Wittkowsky, AK, 2013
)
1.83
""Safe dose" thrombolysis (SDT) plus new oral anticoagulants are expected to become an appealing, safe and effective approach in the treatment of moderate and severe PE in the near future, thereby drastically reducing hospitalization time."( Safe-dose thrombolysis plus rivaroxaban for moderate and severe pulmonary embolism: drip, drug, and discharge.
Bay, C; Schwartz, F; Sharifi, M; Skrocki, L, 2014
)
0.7
""Safe dose" thrombolysis plus rivaroxaban is highly safe and effective in the treatment of moderate and severe PE, leading to favorable early and intermediate-term outcomes and early discharge."( Safe-dose thrombolysis plus rivaroxaban for moderate and severe pulmonary embolism: drip, drug, and discharge.
Bay, C; Schwartz, F; Sharifi, M; Skrocki, L, 2014
)
0.98
"Thromboprophylaxis with rivaroxaban has proved effective and safe in patients undergoing hip and knee replacement surgery."( Efficacy and safety of rivaroxaban versus low-molecular-weight heparin therapy in patients with lower limb fractures.
Jiang, B; Li, H; Long, A; Mao, Z; Tang, P; Xie, Z; Zhang, L; Zhang, S; Zhang, Y, 2014
)
1.02
"Uninterrupted rivaroxaban therapy appears to be as safe and efficacious in preventing bleeding and thromboembolic events in patients undergoing AF ablation as uninterrupted warfarin therapy."( Feasibility and safety of uninterrupted rivaroxaban for periprocedural anticoagulation in patients undergoing radiofrequency ablation for atrial fibrillation: results from a multicenter prospective registry.
Atkins, D; Baheiry, S; Barrett, CD; Bommana, S; Burkhardt, JD; Chalhoub, F; Di Biase, L; Gangireddy, S; Lakkireddy, D; Mansour, MC; Natale, A; Reddy, V; Reddy, YM; Ruskin, J; Sanchez, JE; Santangeli, P; Swarup, V; Vallakati, A; Verma, A, 2014
)
1.03
" Our case report indicates that thrombolysis under nOAC may be safe under certain conditions and emphasizes the importance of establishing and performing specific anticoagulation tests for nOAC."( Safe intravenous thrombolysis in acute stroke despite treatment with rivaroxaban.
Bornkamm, K; Harloff, A, 2014
)
0.64
" No serious adverse events occurred and no persistent adverse events were reported at the end of study."( An open-label study to estimate the effect of steady-state erythromycin on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban in subjects with renal impairment and normal renal function.
Ariyawansa, J; Haskell, L; Moore, KT; Natarajan, J; Turner, KC; Vaidyanathan, S, 2014
)
0.6
"In patients undergoing left atrial RFA, continuous periprocedural rivaroxaban use seems to be as safe as uninterrupted periprocedural phenprocoumon administration."( Safety of continuous periprocedural rivaroxaban for patients undergoing left atrial catheter ablation procedures.
Ammar, S; Buiatti, A; Deisenhofer, I; Dillier, R; Hessling, G; Hofmann, M; Kaess, B; Kathan, S; Kolb, C; Lennerz, C; Pavaci, H; Reents, T; Semmler, V, 2014
)
0.91
"Thrombolysis and/or endovascular thrombectomy might be safe for patients treated with the new anticoagulant rivaroxaban."( Revascularization for acute ischemic stroke is safe for rivaroxaban users.
Fukae, J; Higashi, T; Inoue, T; Iwaasa, M; Kimura, S; Ogata, T; Okawa, M; Tsuboi, Y, 2014
)
0.86
" Little is known about the potential safety issues and the reporting in spontaneous adverse event databases associated with rivaroxaban."( A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2014
)
0.9
"To analyse spontaneous adverse event reports associated with the oral anticoagulant rivaroxaban from Australia, Canada and the USA; and to examine concomitant medicine use that may increase the risk of adverse events."( A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2014
)
0.92
"Spontaneous adverse event report databases from Australia, Canada and the USA were examined for all reports of adverse events associated with rivaroxaban and concomitant medicines from 1 August 2005 to 31 March 2013."( A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2014
)
0.89
"There were 244 spontaneous adverse event reports associated with rivaroxaban from Australia, 536 from Canada and 1,638 from the USA."( A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2014
)
0.93
"A large proportion of adverse event reports for rivaroxaban were associated with use of concomitant medicines, which may have increased the risk of adverse events-in particular, haemorrhage."( A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm.
Barratt, JD; Caughey, GE; Kalisch Ellett, LM; McDonald, CJ, 2014
)
0.95
"Compared with warfarin, periprocedural anticoagulation with dabigatran resulted in fewer minor hemorrhages and total adverse events after AF ablation."( Safety of novel oral anticoagulants compared with uninterrupted warfarin for catheter ablation of atrial fibrillation.
Armbruster, HL; Berger, RD; Calkins, H; Habibi, M; Khurram, IM; Lindsley, JP; Marine, JE; Moranville, MP; Spragg, DD, 2015
)
0.42
" Rywaroxaban more frequently causes minor bleeding, whereas treatment with dabigatran is associated with more frequent gastrointestinal adverse symptoms."( [Comparison of the safety of rivaroxaban versus dabigatran therapy in patients with persistent atrial fibrillation].
Broncel, M; Ciastkowska, A; Duraj, I; Gorzelak-Pabiś, P; Szlagowska, L, 2014
)
0.69
" Comparing the pharmacovigilance reports for the individual NOACs, more hepatic adverse events were reported for rivaroxaban than for dabigatran or apixaban."( Hepatotoxicity of New Oral Anticoagulants (NOACs).
Krähenbühl, S; Liakoni, E; Rätz Bravo, AE, 2015
)
0.63
" Non-vitamin K antagonist oral anticoagulants (NOACs) have emerged as efficacious, safe and convenient stroke prevention agents."( Relative efficacy and safety of non-Vitamin K oral anticoagulants for non-valvular atrial fibrillation: Network meta-analysis comparing apixaban, dabigatran, rivaroxaban and edoxaban in three patient subgroups.
Batson, S; Kachroo, S; Lip, GY; Liu, LZ; Liu, X; Mitchell, SA; Phatak, H, 2016
)
0.63
" The incidence of treatment-emergent adverse events in the safety population was similar between the two groups (944 [36·0%] of 2619 in the rivaroxaban group vs 805 [37·5%] of 2149 in the standard anticoagulation group)."( Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study.
Ageno, W; Gebel, M; Haas, S; Kreutz, R; Mantovani, LG; Monje, D; Schneider, J; Turpie, AG; van Eickels, M; Zell, E, 2016
)
0.92
" Propensity score-adjusted results confirm that rivaroxaban is a safe and effective alternative to standard anticoagulation therapy in a broad range of patients."( Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study.
Ageno, W; Gebel, M; Haas, S; Kreutz, R; Mantovani, LG; Monje, D; Schneider, J; Turpie, AG; van Eickels, M; Zell, E, 2016
)
0.97
" In patients undergoing AF ablation, rivaroxaban appears to be an effective and safe alternative to VKA."( Efficacy and safety of rivaroxaban compared with vitamin K antagonists for peri-procedural anticoagulation in catheter ablation of atrial fibrillation: a systematic review and meta-analysis.
Cappato, R; Hohnloser, SH; Marchlinski, FE; Natale, A; Vamos, M, 2016
)
1.02
"Anticoagulation with NOAC with a short period of periprocedural interruption without bridging with LMWH seems safe and well-tolerated."( Safety of novel oral anticoagulants in catheter ablation of atrial fibrillation.
Hansen, PS; Sanchez, R; Walfridsson, H, 2016
)
0.43
" This study evaluates the total complications and the impact of novel oral anticoagulants (NOACs) compared to phenprocoumon on adverse events in the setting of PVI using CB."( The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.
Dahmen, A; Gorr, E; Hoppe, C; Horlitz, M; Keskin, K; Koektuerk, B; Schoett, M; Turan, CH; Turan, RG; Yang, A; Yorgun, H, 2016
)
0.43
"The incidence of adverse events in PVI using the second-generation CB with the periprocedural administration of NAOCs was not significantly different compared to phenprocoumon."( The Total Incidence of Complications and the Impact of an Anticoagulation Regime on Adverse Events After Cryoballoon Ablation of Atrial Fibrillation: A Single-Center Study of 409 Patients.
Dahmen, A; Gorr, E; Hoppe, C; Horlitz, M; Keskin, K; Koektuerk, B; Schoett, M; Turan, CH; Turan, RG; Yang, A; Yorgun, H, 2016
)
0.43
"There was no identifiable adverse drug reaction, evidence of hemorrhage, significant prolongation of prothrombin time or activated partial thromboplastin time, or increase in transfusion requirements associated with RIV therapy compared to CL and LDA in dogs with pIMHA."( Evaluation of the safety and tolerability of rivaroxaban in dogs with presumed primary immune-mediated hemolytic anemia.
Bianco, D; Morassi, A; Nakamura, RK; Park, E; White, GA, 2016
)
0.69
"89 mg/kg by mouth once daily was safe and well tolerated in a small group of dogs with presumed pIMHA able to tolerate oral medications and treated with a standardized immunosuppressive treatment protocol."( Evaluation of the safety and tolerability of rivaroxaban in dogs with presumed primary immune-mediated hemolytic anemia.
Bianco, D; Morassi, A; Nakamura, RK; Park, E; White, GA, 2016
)
0.69
" All NOACs seem to be safe and effective alternatives to warfarin in a routine care setting."( Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study.
Kjældgaard, JN; Larsen, TB; Lip, GY; Nielsen, PB; Skjøth, F, 2016
)
0.43
"4; and mean HAS-BLED (Hypertension, Abnormal renal and liver function, Stroke, Bleeding, Labile international normalized ratios, Elderly, Drugs or alcohol): 4 ± 1] with AF and biological prostheses, repaired mitral valves, or tubular aortic graft who were treated with the factor Xa inhibitor rivaroxaban due to inefficacy or adverse effects of warfarin."( Safety and Feasibility of Treatment with Rivaroxaban for Non-Canonical Indications: A Case Series Analysis.
Acanfora, C; Acanfora, D; Casucci, G; Ciccone, MM; Dentamaro, I; Furgi, G; Incalzi, RA; Lanzillo, B; Longobardi, M; Scicchitano, P; Zito, A, 2016
)
0.88
" Conclusion Rivaroxaban is safe and effective drug for NVAF patients who are scheduled for an EC."( The Efficacy and Safety of Oral Rivaroxaban in Patients with Non-Valvular Atrial Fibrillation Scheduled for Electrical Cardioversion.
Enomoto, Y; Fujino, T; Ikeda, T; Ito, N; Noro, M; Sugi, K, 2016
)
1.1
" In conclusion, DOACs are effective and safe for the extended treatment of VTE, and may reduce the risk of all-cause mortality."( Safety ad efficacy of direct oral anticoagulants for extended treatment of venous thromboembolism.
Benedetti, R; Fenoglio, L; Imberti, D; Pomero, F, 2016
)
0.43
" Conclusions Rivaroxaban is an effective and safe anticoagulant for thromboprophylaxis after hip arthroplasty or knee arthroplasty if used in a modified regimen involving enoxaparin administered in the inpatient setting followed by rivaroxaban upon hospital discharge."( Efficacy and safety of rivaroxaban thromboprophylaxis after arthroplasty of the hip or knee: retrospective cohort study.
Gibbons, C; Hua, A; Loganathan, V; Patel, S; Vizcaychipi, MP, 2016
)
1.11
" In conclusion, DOACs should be used with caution in APS patients and randomized control trials with clinical primary endpoints assessing clinical efficacy and safety are awaited to establish whether the prescription of DOACs could be a safe alternative to warfarin."( Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature.
Dufrost, V; Risse, J; Wahl, D; Zuily, S, 2016
)
0.43
" In order to contribute to the debate on their safety profile, we conducted a comparative analysis of the reports of suspected adverse drug reactions (ADRs) associated with DOACs in VigiBase."( Safety profile of the direct oral anticoagulants: an analysis of the WHO database of adverse drug reactions.
Biagi, C; Conti, V; Donati, M; Melis, M; Monaco, L; Motola, D; Vaccheri, A; Venegoni, M, 2017
)
0.46
"Cerebrovascular adverse events collected by the Pharmaceutical and Medical Devices Agency (PMDA) during 2014 were analyzed to describe and compare efficacy and safety among patients prescribed DTI and FXa."( Evaluation of the Efficacy and Safety of Direct Oral Anticoagulants in Japanese Patients-Analysis of Pharmaceuticals and Medical Devices Agency Data.
Terayama, Y, 2017
)
0.46
" In addition, NOACs have been demonstrated to be safe and associated with a significant reduction in major and intracranial bleeding events."( [New oral anticoagulants in patients with atrial fibrillation: efficacy and safety data from the real world].
Di Pasquale, G; Riva, L, 2017
)
0.46
"These results suggest that rivaroxaban is effective and safe in extreme elderly patients with atrial fibrillation."( Efficacy and safety of rivaroxaban in extreme elderly patients with atrial fibrillation: Analysis of the Shikoku Rivaroxaban Registry Trial (SRRT).
Bando, S; Fukatani, M; Fukuda, Y; Hiura, N; Ikeda, S; Kakutani, A; Kaname, N; Nakaya, Y; Nishikado, A; Takagi, Y; Yamamoto, K; Yukiiri, K, 2018
)
1.09
" Rivaroxaban-induced hepatotoxicity is unusual, although a number of adverse reports have recently been reported."( Rivaroxaban-induced hepatotoxicity: review of the literature and report of new cases.
Almasio, PL; Giannitrapani, L; Licata, A; Lombardo, V; Minissale, MG; Montalto, G; Morreale, I; Puccia, F; Serruto, A; Soresi, M, 2018
)
2.83
" We report two new cases of adverse events occurred in patients treated with rivaroxaban (20 mg/die) to prevent systemic embolism, who presented with hepatocellular liver injury with onset at 8 weeks after initiation of the drug intake."( Rivaroxaban-induced hepatotoxicity: review of the literature and report of new cases.
Almasio, PL; Giannitrapani, L; Licata, A; Lombardo, V; Minissale, MG; Montalto, G; Morreale, I; Puccia, F; Serruto, A; Soresi, M, 2018
)
2.15
" The secondary efficacy outcome was major adverse cardiovascular events (MACE; composite of myocardial infarction, stroke, and all-cause mortality)."( Meta-Analysis of the Safety and Efficacy of the Oral Anticoagulant Agents (Apixaban, Rivaroxaban, Dabigatran) in Patients With Acute Coronary Syndrome.
Arshad, A; Kaluski, E; Khan, SU; Nasir, F; Riaz, IB; Talluri, S, 2018
)
0.7
"Rivaroxaban (20 mg/15 mg once daily) is an effective and safe alternative to warfarin for stroke prevention in patients with non-valvular AF (NVAF)."( The effectiveness and safety of low-dose rivaroxaban in Asians with non-valvular atrial fibrillation.
Chan, YH; Chang, SH; Kuo, CT; Lee, HF; See, LC; Tu, HT; Wu, LS; Yeh, YH, 2018
)
2.19
"In this cohort of Medicare beneficiaries with VHD (excluding patients with prosthetic valves) and new-onset AF between 2011 and 2013, novel oral non-vitamin K anticoagulants were safe and effective options for prevention of systemic thromboembolism."( Safety and Efficacy of Novel Oral Anticoagulants Versus Warfarin in Medicare Beneficiaries With Atrial Fibrillation and Valvular Heart Disease.
Akintoye, E; Alvarez, P; Briasoulis, A; Inampudi, C; Panaich, S; Vaughan-Sarrazin, M, 2018
)
0.48
" Patients commenced on NOACs should be assessed and followed up in a multidisciplinary AF clinic to ensure safe and effective prescribing and stroke prevention."( Is the prescription right? A review of non-vitamin K antagonist anticoagulant (NOAC) prescriptions in patients with non-valvular atrial fibrillation. Safe prescribing in atrial fibrillation and evaluation of non-vitamin K oral anticoagulants in stroke pre
Burke, C; Collins, R; Coughlan, T; Egom, EE; McAuliffe, C; McHugh, J; Moore, D; Morrissey, E; O'Brien, J; Pharithi, RB; Ranganathan, D; Ryan, D; Vaughan, M, 2019
)
0.51
"Rivaroxaban seems a safe and effective therapeutic option in CKD stage 3b-4 patients."( Safety and effectiveness of rivaroxaban and warfarin in moderate-to-advanced CKD: real world data.
Barbera, V; Bellasi, A; De Pascalis, A; Di Iorio, BR; Di Lullo, L; Fusaro, M; Granata, A; Paoletti, E; Ravera, M; Ronco, C; Russo, D; Tripepi, G, 2018
)
2.22
" Primary outcomes were treatment-emergent major bleeding, adverse events (AEs)/serious AEs, and all-cause death."( Global Prospective Safety Analysis of Rivaroxaban.
Amarenco, P; Bach, M; Camm, AJ; Haas, S; Hess, S; Kim, YH; Kirchhof, P; Lambelet, M; Lanas, F; Radaideh, G; Turpie, AGG, 2018
)
0.75
"The combined use of intraarticular topical TXA with rivaroxaban in patients undergoing TKA is a safe and effective method to reduce blood loss, the need for transfusion, and wound complications without elevating the risk of DVT."( Combined use of topical intraarticular tranexamic acid and rivaroxaban in total knee arthroplasty safely reduces blood loss, transfusion rates, and wound complications without increasing the risk of thrombosis.
Kang, MW; Kim, JI; Kim, YT; Lee, JK; Lee, YM, 2018
)
0.97
"The safety of the NOACs compared with warfarin was generally favourable across different patient subgroups, including those perceived to be at "high risk" for adverse outcomes."( The safety of NOACs in atrial fibrillation patient subgroups: A narrative review.
Lip, GYH, 2019
)
0.51
"In clinically stable CVT rivaroxaban is safe and effective and may be used without previous heparin therapy."( Is it safe to treat cerebral venous thrombosis with oral rivaroxaban without heparin? A preliminary study from 20 patients.
Akhtar, S; Kumar, P; Muthukalathi, K; Muthukumar, K; Shankar Iyer, R; Tcr, R, 2018
)
1.03
" Our data might give some assurance to clinicians that apixaban can be an effective and safe therapeutic option for treatment of patients with venous thromboembolism."( Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis.
Brown, J; Dawwas, GK; Dietrich, E; Park, H, 2019
)
0.78
"This real-world study suggests that in the setting of polypharmacy and NVAF, rivaroxaban is an effective and safe alternative to warfarin."( Influence of Polypharmacy on the Effectiveness and Safety of Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation.
Baker, WL; Bunz, TJ; Coleman, CI; Eriksson, D; Martinez, BK; Meinecke, AK; Sood, NA, 2019
)
0.98
"Gastrointestinal side effect profiles of these four agents in a real-life setting is consistent with the results obtained from the present study."( A link between cytotoxicity in cell culture and gastrointestinal side effects of oral anticoagulants: bench-to-bedside.
Gurpinar, OA; Karasoy, D; Kubat, E; Onur, MA,
)
0.13
"Real-world outcomes of the XAPASS showed incidence rates of major bleeding and thromboembolic events, suggesting that rivaroxaban is safe and effective in Japanese daily clinical practice (Clinicaltrials."( Real-world outcomes of the Xarelto Post-Authorization Safety & Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS).
Ikeda, T; Kitazono, T; Minematsu, K; Miyamoto, S; Murakawa, Y; Nakagawara, J; Ogawa, S; Ohashi, Y; Okayama, Y; Sunaya, T; Takeichi, M; Yamanaka, S, 2019
)
0.72
"Direct oral anticoagulants (DOACs) are at least as efficacious and safe as warfarin among non-valvular atrial fibrillation (NVAF) patients; limited evidence is available regarding NVAF patients with heart failure (HF)."( Effectiveness and safety of oral anticoagulants in older adults with non-valvular atrial fibrillation and heart failure.
Amin, A; Dhamane, A; Di Fusco, M; Friend, K; Garcia Reeves, AB; Keshishian, A; Li, X; Luo, X; Mardekian, J; Nadkarni, A; Pan, X; Rosenblatt, L; Yuce, H, 2019
)
0.51
" Analysing subgroups in these studies demonstrated that direct oral anticoagulants during long-term administration were at least as effective and safe as vitamin K antagonists."( [Venous thromboembolic complications in oncological patients: present-day possibilities of effective and safe anticoagulant therapy].
Bagaev, KV; Fokin, AA, 2019
)
0.51
" To better evaluate the rates of DOAC-related adverse events (AEs) on a population level, we examined AEs reported to the FDA for three commonly used DOACs and warfarin."( A comparative analysis of the safety profile of direct oral anticoagulants using the FDA adverse event reporting system.
DeLoughery, EP; Shatzel, JJ, 2019
)
0.51
"We evaluated the FDA Adverse Event Reporting System (FAERS) database, which compiles reported drug-related AEs from 1969 onwards."( A comparative analysis of the safety profile of direct oral anticoagulants using the FDA adverse event reporting system.
DeLoughery, EP; Shatzel, JJ, 2019
)
0.51
"To assess the effectiveness and safety of rivaroxaban versus warfarin for the prevention of major adverse cardiovascular events (MACE) and major adverse limb events (MALE) in patients with type 2 diabetes (T2D) and non-valvular atrial fibrillation (NVAF)."( Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes.
Baker, WL; Beyer-Westendorf, J; Bunz, TJ; Coleman, CI; Eriksson, D; Meinecke, AK; Sood, NA, 2019
)
1.07
" These drugs are well tolerated in the short term, but long-term treatment was associated with adverse events in observational studies."( Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin.
Alings, M; Anand, SS; Avezum, A; Bhatt, DL; Bosch, J; Branch, KRH; Bruns, NC; Commerford, PJ; Connolly, SJ; Dagenais, GR; Dans, AL; Diaz, R; Dyal, L; Eikelboom, JW; Ertl, G; Felix, C; Fox, KAA; Guzik, TJ; Hart, RG; Hori, M; Kakkar, AK; Keltai, M; Kim, JH; Lanas, F; Leong, D; Lewis, BS; Liang, Y; Lonn, EM; Lopez-Jaramillo, P; Maggioni, AP; Metsarinne, KP; Moayyedi, P; Muehlhofer, E; O'Donnell, M; Parkhomenko, AN; Piegas, LS; Pogosova, N; Probstfield, J; Ryden, L; Shestakovska, O; Steg, PG; Störk, S; Tonkin, AM; Torp-Pedersen, C; Verhamme, PB; Vinereanu, D; Widimsky, P; Yusoff, K; Yusuf, S; Zhu, J, 2019
)
0.73
"In a large placebo-controlled randomized trial, we found that pantoprazole is not associated with any adverse event when used for 3 years, with the possible exception of an increased risk of enteric infections."( Safety of Proton Pump Inhibitors Based on a Large, Multi-Year, Randomized Trial of Patients Receiving Rivaroxaban or Aspirin.
Alings, M; Anand, SS; Avezum, A; Bhatt, DL; Bosch, J; Branch, KRH; Bruns, NC; Commerford, PJ; Connolly, SJ; Dagenais, GR; Dans, AL; Diaz, R; Dyal, L; Eikelboom, JW; Ertl, G; Felix, C; Fox, KAA; Guzik, TJ; Hart, RG; Hori, M; Kakkar, AK; Keltai, M; Kim, JH; Lanas, F; Leong, D; Lewis, BS; Liang, Y; Lonn, EM; Lopez-Jaramillo, P; Maggioni, AP; Metsarinne, KP; Moayyedi, P; Muehlhofer, E; O'Donnell, M; Parkhomenko, AN; Piegas, LS; Pogosova, N; Probstfield, J; Ryden, L; Shestakovska, O; Steg, PG; Störk, S; Tonkin, AM; Torp-Pedersen, C; Verhamme, PB; Vinereanu, D; Widimsky, P; Yusoff, K; Yusuf, S; Zhu, J, 2019
)
0.73
"Rivaroxaban is effective and safe for the treatment of cancer-associated VTE."( Retrospective evaluation of the efficacy and safety of rivaroxaban in patients with cancer-associated venous thromboembolism: A single-center study.
Choi, YJ; Kim, HJ; Oh, SB; Seol, YM, 2019
)
2.2
"We analyzed adverse event cases submitted to the Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from January 2013 to December 2018."( Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS).
Choshen Cohen, L; Goldstein, R; Muszkat, M; Perlman, A; Singer, DE; Wanounou, M, 2019
)
0.51
"During this period, 9693 adverse event cases reported concomitant use of FXa-DOACs and AEDs."( Ischemic and Thrombotic Events Associated with Concomitant Xa-inhibiting Direct Oral Anticoagulants and Antiepileptic Drugs: Analysis of the FDA Adverse Event Reporting System (FAERS).
Choshen Cohen, L; Goldstein, R; Muszkat, M; Perlman, A; Singer, DE; Wanounou, M, 2019
)
0.51
" The risks of ischemic stroke, intracranial hemorrhage (ICH), major bleeding, mortality, and composite adverse events were compared between NOACs and warfarin in all patients ≥ 65 years of age and, specifically, with different age strata (ie, 65-74, 75-89, ≥ 90 years)."( Comparing the Effectiveness and Safety of Nonvitamin K Antagonist Oral Anticoagulants and Warfarin in Elderly Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study.
Chao, TF; Chen, SA; Chen, TJ; Chiang, CE; Liao, JN; Lip, GYH, 2020
)
0.56
"Compared with warfarin, NOACs were associated with a significantly lower risk of adverse events, with heterogeneity in treatment effects among different age strata."( Comparing the Effectiveness and Safety of Nonvitamin K Antagonist Oral Anticoagulants and Warfarin in Elderly Asian Patients With Atrial Fibrillation: A Nationwide Cohort Study.
Chao, TF; Chen, SA; Chen, TJ; Chiang, CE; Liao, JN; Lip, GYH, 2020
)
0.56
"Atrial fibrillation (AF) ablation under uninterrupted warfarin use is safe and recommended by experts."( Safety of Catheter Ablation of Atrial Fibrillation Under Uninterrupted Rivaroxaban Use.
Agrizzi, RS; Elias Neto, J; Futuro, GMC; Kuniyoshi, R; Merçon, ES; Silva, MA; Vasconcelos, D, 2020
)
0.79
" Daily 10mg rivaroxaban is a safe and effective dose for the prevention and treatment of elderly patients with thrombotic diseases."( Clinical efficacy and drug safety of rivaroxaban in the prevention and treatment of senile thromboembolic diseases.
Daoli, G; Hongwei, L; Li, R, 2020
)
1.21
" Deferring CUS for up to 24 hours in patients with suspected DVT with therapeutic doses of rivaroxaban is a safe strategy."( Safety and feasibility of rivaroxaban in deferred workup of patients with suspected deep vein thrombosis.
Dahm, AEA; Fronas, SG; Ghanima, W; Gleditsch, J; Holst, R; Jørgensen, CT; Klok, FA; Raouf, N; Wik, HS, 2020
)
1.08
" Efficacy and safety outcomes, including stroke, ischemic stroke, stroke or systemic embolism, myocardial infarction, major adverse cardiac events, major bleeding, intracranial hemorrhage, and major gastrointestinal bleeding were collected for meta-analysis."( The Safety and Efficacy of Rivaroxaban Compared with Warfarin in Patients with Atrial Fibrillation and Diabetes: A Systematic Review and Meta-analysis.
Hua, Y; Kong, XQ; Qu, Q; Su, Y; Sun, JY; Sun, W; Wang, HY, 2021
)
0.92
" Due to mechanism of action; most common side effect may be seen with hemorrhage."( Thrombocytopenia due to rivaroxaban: A rare adverse effect.
Afacan Öztürk, HB; Akyol, P; Albayrak, M; Aras, MR; Sağlam, B; Tığlıoğlu, M; Yıldız, A, 2020
)
0.87
"Naranjo adverse drug reaction probability scale calculated as 7 points."( Thrombocytopenia due to rivaroxaban: A rare adverse effect.
Afacan Öztürk, HB; Akyol, P; Albayrak, M; Aras, MR; Sağlam, B; Tığlıoğlu, M; Yıldız, A, 2020
)
0.87
"Our real-life data study suggests that secondary stroke prevention with DOACs is as effective and safe as primary prevention, both in standard and reduced doses, in a typical group of patients who are older than patients included in RCTs."( Effectiveness and Safety of Direct Oral Anticoagulants in the Secondary Stroke Prevention of Elderly Patients: Ljubljana Registry of Secondary Stroke Prevention.
Frol, S; Hudnik, LK; Oblak, JP; Šabovič, M; Sernec, LP, 2020
)
0.56
" The primary efficacy endpoint is a composite of major adverse cardiac events (MACE), including cardiac death, myocardial infarction, re-revascularization or stroke, and major bleeding events."( Rationale and Design of the H-REPLACE Study: Safety and Efficacy of LMWH Versus Rivaroxaban in ChinEse Patients HospitaLized with Acute Coronary SyndromE.
Fang, Z; Hu, X; Liu, Q; Tang, L; Xiao, Y; Zhou, S, 2022
)
0.95
" Anticoagulant therapy appeared safe and efficacious and was associated with reduced clot burden in most children with symptomatic or asymptomatic CVC-VTE."( Safety and efficacy of anticoagulant therapy in pediatric catheter-related venous thrombosis (EINSTEIN-Jr CVC-VTE).
Amedro, P; Bajolle, F; Berkowitz, SD; Bonnet, D; Chain, J; Chan, AK; Gauger, C; Ikeyama, T; Karakas, Z; Kenet, G; Kubitza, D; Lam, JCM; Lensing, AWA; Majumder, M; Male, C; Massicotte, MP; Monagle, P; Nurmeev, I; Palumbo, JS; Pap, ÁF; Prins, MH; Saracco, P; Smith, WT; Thom, K; Young, G, 2020
)
0.56
"In the VOYAGER PAD trial, rivaroxaban plus aspirin reduced the risk of adverse cardiovascular and limb events with an early benefit for acute limb ischemia regardless of clopidogrel use."( Rivaroxaban and Aspirin in Peripheral Artery Disease Lower Extremity Revascularization: Impact of Concomitant Clopidogrel on Efficacy and Safety.
Anand, SS; Bauersachs, R; Berkowitz, SD; Bonaca, MP; Brackin, T; Brasil, D; Capell, WH; Debus, ES; Haskell, L; Hess, CN; Hiatt, WR; Jaeger, N; Madaric, J; Muehlhofer, E; Nehler, MR; Pap, AF; Patel, MR; Sillesen, H; Szalay, D, 2020
)
2.3
"This retrospective study included 1777 non-permanent AF patients taking rivaroxaban for ≥ 1 month between 2011 and 2016 from a multicenter cohort in Taiwan, and compared concomitant AAD use against clinical outcome endpoints for safety, effectiveness, and major adverse cardiac events (MACE)."( Safety and Effectiveness of Rivaroxaban in Combination with Various Antiarrhythmic Drugs in Patients with Non-Permanent Atrial Fibrillation.
Chen, CY; Chiou, WR; Chuang, JY; Huang, CC; Kuo, JY; Lee, YH; Liao, FC; Lin, PL; Liu, LY; Su, MI; Tsai, CT; Wu, YJ, 2021
)
1.15
" <br><b>Conclusion: </b>Implementation of extended prophylaxis with rivaroxaban is easy, safe and does not increase rates of postoperative bleeding."( Implementation of extended prolonged venous thromboembolism prophylaxis with rivaroxaban after major abdominal and pelvic surgery - overview of safety and early outcomes.
Kebkalo, A; Poylin, V; Tryliskyy, Y; Tyselskyi, V; Wong, D, 2020
)
1.01
" Therefore, NOAC is an effective and safe alternative to warfarin in these patients."( Effectiveness and safety of non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation and valvular heart disease.
Hung, CS; Li, HJ; Lin, FJ; Lin, SY; Wang, CC, 2021
)
0.62
"Patients with lower extremity peripheral artery disease (PAD) are at increased risk of major adverse limb events (MALE)."( The efficacy and safety of direct oral anticoagulants plus aspirin in symptomatic lower extremity peripheral arterial disease: a systematic review and meta-analysis of randomized controlled trials.
Costa, G; Gonçalves, L; Teixeira, R, 2021
)
0.62
"These results suggest that rivaroxaban is an effective and safe treatment option among NVAF patients with obesity in a commercially-insured US population."( Real-world effectiveness and safety of rivaroxaban versus warfarin among non-valvular atrial fibrillation patients with obesity in a US population.
Ashton, V; Berger, JS; Jung, Y; Kharat, A; Laliberté, F; Lefebvre, P; Lejeune, D; Moore, KT, 2021
)
1.19
" Most side effects relate to hemorrhagic complications, however, also non-hemorrhagic side effect may be potentially life threatening."( Life-Threatening Non-Allergic Drug Hypersensitivity Reaction as a Very Rare Side Effect of Rivaroxaban Administration in the Netherlands.
Hakkenbrak, NAG; Truijers, M, 2021
)
0.84
"The low incidence of adverse events, including stroke/SE and bleeding, in patients prescribed rivaroxaban by general practitioners supports its use as a safe and efficacious treatment in the standard clinical care of high-risk patient populations."( Effectiveness and Safety of Rivaroxaban by General Practitioners - A Multicenter, Prospective Study in Japanese Patients With Non-Valvular Atrial Fibrillation (GENERAL).
Akao, M; Hatori, Y; Hiramitsu, S; Kamada, H; Kusano, K; Matsui, K; Miyamoto, K; Odakura, H; Ogawa, H; Sugishita, N; Tsuji, H, 2021
)
1.13
" The NOACs seem to be a safe option also in elderly patients."( Effectiveness and safety of oral anticoagulants in elderly patients with atrial fibrillation.
Ghanima, W; Halvorsen, S; Jonasson, C; Rutherford, OW; Söderdahl, F, 2022
)
0.72
"Direct oral anticoagulants (DOACs) have been proven to be effective and safe for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF)."( Dose specific effectiveness and safety of DOACs in patients with non-valvular atrial fibrillation: A Canadian retrospective cohort study.
Dasgupta, K; Godin, R; Nedjar, H; Rahme, E; Tagalakis, V, 2021
)
0.62
"Overall, the risks of the primary efficacy outcomes or adverse limb events were significantly lower with rivaroxaban than with aspirin or warfarin alone in patients with PAD."( Efficacy and Safety of Rivaroxaban Therapy for Patients With Peripheral Artery Disease: A Systematic Review and Meta-Analysis.
Han, W; Hao, Y; Mou, D; Wang, J, 2021
)
1.15
" Setting FDA Adverse Event Reporting System (FAERS) database."( Evaluation of rivaroxaban-, apixaban- and dabigatran-associated hemorrhagic events using the FDA-Adverse event reporting system (FAERS) database.
Cui, X; Guo, M; Thai, S; Wang, T; Wei, J; Xu, W; Zhao, Y; Zhou, J, 2021
)
0.98
" The primary efficacy endpoint was major adverse cardiovascular events (MACE) and the primary safety endpoint major bleeding."( Efficacy and safety of dual-pathway inhibition in patients with cardiovascular disease: a meta-analysis of 49 802 patients from 7 randomized trials.
Andreotti, F; Angiolillo, DJ; Benenati, S; Capodanno, D; Crea, F; D'Amario, D; Galli, M, 2022
)
0.72
"Xa inhibitors were associated with a higher risk of major adverse cardiovascular events and bleeding among HF and CAD or PAD patients."( Efficacy and safety of Xa inhibitors in patients with heart failure and coronary or peripheral artery disease: a systematic review and meta-analysis of randomized controlled trials.
Chen, Y; Feng, X; Gu, Z; Li, X; Qi, C; Sun, Y; Zhou, L, 2021
)
0.62
"Oral anticoagulant (OAC)-related adverse events are high post-hospitalization."( Derivation and validation of predictors of oral anticoagulant-related adverse events in seniors transitioning from hospital to home.
Benipal, H; Douketis, J; Foster, G; Holbrook, A; Ma, J; Paterson, JM; Thabane, L, 2021
)
0.62
" Safety and efficacy of rivaroxaban (bleedings and recurrent venous thromboembolism), cumulative prevalence of post-thrombotic syndrome (PTS), primary patency, clinically driven target lesion revascularization rate, and other adverse events including all-cause mortality and vascular events (systemic embolism, acute coronary syndrome, ischemic stroke, and transient ischemic attack) were retrospectively analyzed."( Safety and Efficacy of Rivaroxaban for Inferior Vena Cava Thrombosis after Successful Catheter-Directed Thrombolysis.
Du, J; Fu, J; Liu, F; Nie, M; Sun, J; Yan, Z, 2022
)
1.34
" This study intends to carry out an evaluation of whether combining rivaroxaben with aspirin will be effective and safe in treating patients experiencing chronic CAD."( Evaluation of efficacy and safety of rivaroxaban combined with aspirin in patients with chronic coronary artery disease: A protocol for systematic review and meta-analysis.
Li, X; Wang, H; Wu, H; Wu, X; Xie, G, 2022
)
0.99
" The primary outcome endpoint was evaluated based on the adverse cardiac and cerebrovascular events within 12 months."( Safety and Efficacy Evaluation of Antithrombotic Therapy with Rivaroxaban and Clopidogrel After PCI in Chinese Patients.
Bai, L; Cui, XR; Fu, LZ; Yang, XH; Zhang, JD; Zhou, YQ,
)
0.37
"00%) main adverse cardiac and cerebrovascular events occurred during the 12 months of follow-up, including 5 (9."( Safety and Efficacy Evaluation of Antithrombotic Therapy with Rivaroxaban and Clopidogrel After PCI in Chinese Patients.
Bai, L; Cui, XR; Fu, LZ; Yang, XH; Zhang, JD; Zhou, YQ,
)
0.37
" We used weighted Cox proportional hazards models to estimate separately the hazard ratios (HRs) with 95% confidence intervals (CIs) of ischemic stroke, major bleeding, and major adverse limb events associated with the use of apixaban compared with rivaroxaban."( Effectiveness and Safety of Apixaban versus Rivaroxaban in Patients with Atrial Fibrillation and Type 2 Diabetes Mellitus.
Azoulay, L; Chowdhury, KR; Michaud, J; Renoux, C; Yin, H; Yu, OHY, 2022
)
1.16
"Prior observational studies suggest rivaroxaban is safe and effective among patients with morbid obesity who suffered a venous thromboembolism (VTE) event, but existing data are more limited in the broader population of VTE patients with obesity."( Effectiveness, safety, and healthcare costs associated with rivaroxaban versus warfarin among venous thromboembolism patients with obesity: a real-world study in the United States.
Ashton, V; Berger, JS; Jung, Y; Kharat, A; Laliberté, F; Lefebvre, P; Lejeune, D; Moore, KT, 2022
)
1.24
" In conclusion, DOACs for atrial fibrillation or VTE in patients with extreme body weights appear safe and effective when compared to warfarin."( Evaluation of safety and efficacy outcomes of direct oral anticoagulants versus warfarin in normal and extreme body weights for the treatment of atrial fibrillation or venous thromboembolism.
Kiser, TH; Mueller, SW; Novak, AR; Shakowski, C; Trujillo, TC; Wright, GC, 2022
)
0.72
"The aim of this study was to analyze the clinical characteristics of fatal adverse events (AEs) of rivaroxaban combined with aspirin and to underline the importance of the rational use of drugs."( Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase.
Ding, Q; Yan, S; Yue, QY; Zhang, Q, 2022
)
1.24
"By January 19, 2020, 2309 fatal adverse event reports of rivaroxaban combined with aspirin from 21 countries were entered in VigiBase."( Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase.
Ding, Q; Yan, S; Yue, QY; Zhang, Q, 2022
)
1.27
" The INR attainment rate, coagulation index, thromboembolism, bleeding, and adverse reactions were compared between the two groups."( A Cohort Study on the Safety and Efficacy of Warfarin and Rivaroxaban in Anticoagulant Therapy in Patients with Atrial Fibrillation Study.
Wang, L; Yao, W, 2022
)
0.97
"For a long time, vitamin K antagonists (VKA) were the only oral anticoagulation therapy available to reduce adverse events in atrial fibrillation (AF) patients."( A comparison of front-line oral anticoagulants for the treatment of non-valvular atrial fibrillation: effectiveness and safety of direct oral anticoagulants in the FANTASIIA registry.
Anguita, M; Badimón, L; Bertomeu-Martínez, V; Cequier, Á; Esteve-Pastor, MA; Lip, GYH; López-Gálvez, R; Marín, F; Muñiz, J; Otero, D; Rivera-Caravaca, JM; Roldán-Rabadán, I; Ruiz-Ortiz, M, 2022
)
0.72
" It is critical to identify safe and effective anticoagulation therapy for use in this population."( Anticoagulation and BMI: effect of high body weight on the safety and efficacy of direct oral anticoagulants.
Bansal, A; Eisele, CD; Jain, R; Julian, K; Mausteller, KG; Patel, P, 2022
)
0.72
" Direct oral anticoagulants are a new, preferred medication option for this, but it is unclear how safe or effective they are in obese people; there is some concern that because of increased body weight, individuals may not get enough medicine to effectively prevent clots from forming, which would ultimately put them at risk for clotting and serious adverse health outcomes such as stroke."( Anticoagulation and BMI: effect of high body weight on the safety and efficacy of direct oral anticoagulants.
Bansal, A; Eisele, CD; Jain, R; Julian, K; Mausteller, KG; Patel, P, 2022
)
0.72
"Short-term, low-dose rivaroxaban seems safe and effective for IDDVT treatment."( Effectiveness and safety of the direct oral anticoagulant in acute distal deep vein thrombosis: From the prospective multicenter observational study, J'xactly, in Japan.
Fukuda, I; Hirayama, A; Ikeda, T; Maeda, H; Mo, M; Nakamura, M; Okumura, Y; Takayama, M; Yamada, N; Yamashita, T; Yamazaki, T, 2023
)
1.23
" CONCLUSIONS AND RELEVANCE: In our experience, the use of DOAC was safe in selected patients treated with KI, but unclear with bevacizumab."( Safety of direct oral anticoagulants in patients with advanced solid tumors receiving anti-VEGF agents: a retrospective study.
Albiges, L; Baudin, E; Besse, B; Boileve, A; Ducreux, M; Hadoux, J; Leary, A; Malka, D; Maulard, A; Mir, O; Rieutord, A; Scotté, F, 2022
)
0.72
" Poisson regression and Cox proportional hazard models were used to estimate adjusted adverse event rates."( Adverse events in low versus normal body weight patients prescribed apixaban for atrial fibrillation.
Ali, MA; Barnes, GD; DeCamillo, D; Haymart, B; Kaatz, S; Kong, X, 2023
)
0.91
"The primary safety end point was bleeding events, as defined by the International Society on Thrombosis and Haemostasis, and the primary efficacy end point was major adverse cardiovascular events (MACEs), including cardiac death, myocardial infarction, rerevascularization, or stroke during the 6-month follow-up."( Effect of Rivaroxaban vs Enoxaparin on Major Cardiac Adverse Events and Bleeding Risk in the Acute Phase of Acute Coronary Syndrome: The H-REPLACE Randomized Equivalence and Noninferiority Trial.
Chen, F; Fu, G; Ge, L; Huang, L; Jiang, W; Liu, C; Liu, Q; Ouyang, Z; Pan, G; Pan, H; Shen, Q; Xiao, Y; Zeng, G; Zhang, Y; Zheng, Z; Zhou, C; Zhou, S; Zhu, C, 2023
)
1.31
" The primary comprehensive endpoint was a major adverse cardiovascular event (MACE) composite of cardiovascular death, stroke, or myocardial infarction, while the secondary endpoints were cardiovascular death, all-cause stroke, ischemic stroke, myocardial infarction, and all-cause death."( Prophylactic Efficacy and Safety of Antithrombotic Regimens in Patients with Stable Atherosclerotic Cardiovascular Disease (S-ASCVD): A Bayesian Network Meta-Regression Analysis.
Chen, X; Jiang, L; Liu, C; Su, J; Zheng, N; Zhong, J, 2023
)
0.91
" The secondary endpoint is a composite of major adverse cardiovascular and cerebrovascular events (MACCE), including all-cause death, cardiac death, nonfatal myocardial infarction, stent thrombosis, ischemia-driven target vessel revascularization, and stroke."( Efficacy and safety of rivaroxaban plus clopidogrel versus aspirin plus clopidogrel in patients with coronary atherosclerotic heart disease and gastrointestinal disease undergoing percutaneous coronary intervention: study protocol for a non-inferiority ra
Gong, Y; Li, J; Wang, X; Wang, Y; Zhou, T, 2023
)
1.22
"The development of an optimal stroke prevention strategy, including the use of oral anticoagulant (OAC) therapy, is particularly important for patients with atrial fibrillation (AF) who are living with dementia, a condition that increases the risk of adverse outcomes."( Comparative Effectiveness and Safety of Oral Anticoagulants by Dementia Status in Older Patients With Atrial Fibrillation.
Bessette, LG; Bykov, K; Cervone, A; Kim, DH; Lin, KJ; Mastrorilli, JM; Singer, DE, 2023
)
0.91
"In this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups."( Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial.
Alberio, L; Borbély, Y; Candinas, D; Deichsel, F; Fringeli, Y; Kessler, U; Kröll, D; Nett, PC; Nocito, A; Rommers, N; Stirnimann, G; Zehetner, J, 2023
)
1.45
"Rivaroxaban may be a safe and effective alternative in LDLT recipients with no significant adverse incidents."( Exploring safety and efficacy of rivaroxaban after living donor liver transplantation: a retrospective study.
Dar, FS; Khalid, A; Khan, BA; Khan, MY; Naveed, A; Rashid, S; Saeed, Z, 2023
)
2.63
" Outcomes included major adverse cardiovascular events, all cause death, major bleeding and myocardial infarction."( Comparison efficacy and safety of different antiplatelet or anticoagulation drugs in chronic coronary syndromes patients: A Bayesian network meta-analysis.
Liu, C; Ma, L, 2023
)
0.91
" In head-to-head comparison, no significant difference was observed between all antithrombotic treatment strategies with respect to primary endpoint of major adverse cardiovascular events."( Comparison efficacy and safety of different antiplatelet or anticoagulation drugs in chronic coronary syndromes patients: A Bayesian network meta-analysis.
Liu, C; Ma, L, 2023
)
0.91

Pharmacokinetics

The oral, direct Factor Xa inhibitor rivaroxaban has been approved in adult patients for several thromboembolic disorders. The pharmacokinetic properties of rivroxaban in virtual populations of children were simulated for body weight-related dosing regimen.

ExcerptReferenceRelevance
" Pharmacodynamic effects (inhibition of factor Xa activity, prothrombin time, activated partial thromboplastin time, and Hep Test) and plasma concentration profiles were dose-dependent."( Safety, pharmacodynamics, and pharmacokinetics of single doses of BAY 59-7939, an oral, direct factor Xa inhibitor.
Becka, M; Kubitza, D; Voith, B; Wensing, G; Zuehlsdorf, M, 2005
)
0.33
" The elimination half-life after oral administration was short in both species (0."( Pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--in rats and dogs.
Buetehorn, U; Daehler, HP; Kohlsdorfer, C; Pleiss, U; Sandmann, S; Schlemmer, KH; Schwarz, T; Steinke, W; Weinz, C, 2005
)
0.33
" Cmax of rivaroxaban was unaffected in subjects >120 kg but was increased by 24% in subjects weighing < or = 50 kg, resulting in a small (15%) increase in prolongation of prothrombin time, which was not considered clinically relevant."( Body weight has limited influence on the safety, tolerability, pharmacokinetics, or pharmacodynamics of rivaroxaban (BAY 59-7939) in healthy subjects.
Becka, M; Kubitza, D; Mueck, W; Zuehlsdorf, M, 2007
)
0.97
" Pharmacokinetic parameters that were estimated using the models agreed closely with results from full-profile patients in the hip study, demonstrating that rivaroxaban pharmacokinetics are predictable."( Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery.
Bauer, KA; Borris, L; Dahl, OE; Eriksson, BI; Fisher, WD; Gent, M; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Kwong, LM; Misselwitz, F; Mueck, W; Turpie, AG, 2008
)
0.79
" Rivaroxaban pharmacodynamic effects (inhibition of FXa activity and prolongation of prothrombin time, activated partial thromboplastin time and HepTest) all showed a similar pattern, with maximum inhibition of FXa activity increasing from 68% after rivaroxaban 30 mg to 75% after 40 mg and no further increase with the 50 mg dose."( Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects.
Becka, M; Kubitza, D; Mueck, W; Roth, A, 2008
)
1.49
" While the anticoagulant effect of the new thrombin and FXa inhibitors is similar, differences in the pharmacokinetic and pharmacodynamic parameters may influence their use in clinical practice."( Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development.
Eriksson, BI; Quinlan, DJ; Weitz, JI, 2009
)
0.35
" Its pharmacokinetic characteristics include rapid absorption, high oral availability, high plasma protein binding and a half-life of aprox."( [Pharmacokinetics and pharmacodynamics of the new oral anticoagulants dabigatran and rivaroxaban].
Climent Grana, E; Jover Botella, A; Ordovás Baines, JP; Valero García, I,
)
0.36
"Rivaroxaban clearance is decreased with increasing renal impairment, leading to increased plasma exposure and pharmacodynamic effects, as expected for a partially renally excreted drug."( Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor.
Becka, M; Bruck, H; Halabi, A; Klause, N; Kubitza, D; Lufft, V; Maatouk, H; Mueck, W; Philipp, T; Wand, DD, 2010
)
2.03
" These observations support the investigation of potential pharmacokinetic and pharmacodynamic interactions between PPIs and anticoagulants."( Effect of multiple doses of omeprazole on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban.
Ariyawansa, J; Burton, PB; Moore, KT; Plotnikov, AN; Thyssen, A; Vaccaro, N, 2011
)
0.58
" Population pharmacokinetic and pharmacodynamic analyses of rivaroxaban in patients in these two phase II studies were conducted to characterize the pharmacokinetics/pharmacodynamics of rivaroxaban and the relationship between important patient covariates and model parameters."( Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention.
Agnelli, G; Decousus, H; Lensing, AW; Misselwitz, F; Mueck, W; Prandoni, P, 2011
)
2.05
"A population pharmacokinetic model was developed using plasma samples from these patients."( Rivaroxaban: population pharmacokinetic analyses in patients treated for acute deep-vein thrombosis and exposure simulations in patients with atrial fibrillation treated for stroke prevention.
Agnelli, G; Decousus, H; Lensing, AW; Misselwitz, F; Mueck, W; Prandoni, P, 2011
)
1.81
" It is the largest population pharmacokinetic and pharmacodynamic study on rivaroxaban conducted to date (n= 2290)."( Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with acute coronary syndromes.
Burton, P; Gibson, M; Moore, K; Mueck, W; Plotnikov, A; Rossenu, S; Stuyckens, K; Vermeulen, A; Xu, XS, 2012
)
0.86
" METHODS A population pharmacokinetic model was developed using pharmacokinetic samples from 2290 patients in Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome Thrombolysis in Myocardial Infarction 46."( Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with acute coronary syndromes.
Burton, P; Gibson, M; Moore, K; Mueck, W; Plotnikov, A; Rossenu, S; Stuyckens, K; Vermeulen, A; Xu, XS, 2012
)
0.63
" The estimated pharmacokinetic and pharmacodynamic parameters for the ACS patients were comparable to those for venous thromboembolism prevention, deep vein thrombosis and atrial fibrillation patients."( Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with acute coronary syndromes.
Burton, P; Gibson, M; Moore, K; Mueck, W; Plotnikov, A; Rossenu, S; Stuyckens, K; Vermeulen, A; Xu, XS, 2012
)
0.63
"A physiologically based pharmacokinetic (PBPK) model was developed to simulate rivaroxaban pharmacokinetics in young (20-45 years) or older (55-65 years) subjects with normal renal function, mild, moderate and severe renal impairment, with or without concomitant use of the combined P-gp and moderate CYP3A4 inhibitor, erythromycin."( Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice.
Berglund, EG; Booth, BP; Bullock, J; Grillo, JA; Huang, SM; Lesko, LJ; Lu, M; Pang, KS; Rahman, A; Robie-Suh, K; Zhang, L; Zhao, P, 2012
)
0.8
" Consequently, the pharmacodynamic responses were significantly enhanced in subjects with moderate hepatic impairment."( Effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of a single dose of rivaroxaban, an oral, direct Factor Xa inhibitor.
Alatrach, A; Becka, M; Halabi, A; Hinrichsen, H; Kubitza, D; Mueck, W; Roth, A, 2013
)
0.61
"Moderate (but not mild) hepatic impairment reduced total body clearance of rivaroxaban after a single 10 mg dose, leading to increased rivaroxaban exposure and pharmacodynamic effects."( Effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of a single dose of rivaroxaban, an oral, direct Factor Xa inhibitor.
Alatrach, A; Becka, M; Halabi, A; Hinrichsen, H; Kubitza, D; Mueck, W; Roth, A, 2013
)
0.84
"The pharmacokinetic effects of substrates or inhibitors of CYP3A4, P-gp and Bcrp (ABCG2) on rivaroxaban were studied in healthy volunteers."( Co-administration of rivaroxaban with drugs that share its elimination pathways: pharmacokinetic effects in healthy subjects.
Becka, M; Kubitza, D; Mueck, W, 2013
)
0.93
" Pharmacokinetic and pharmacodynamic parameters were determined."( The influence of age and gender on the pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct Factor Xa inhibitor.
Becka, M; Kubitza, D; Mueck, W; Roth, A, 2013
)
0.62
" Pharmacokinetic parameters, including the area under the plasma concentration-time curve after a single dose, the maximum drug concentration in plasma after a single dose, dose-adjusted values of area under the plasma concentration-time curve and maximum drug concentration in plasma after a single dose, half-life associated with the terminal slope, and time to maximum concentration in plasma after a single dose were evaluated."( The effect of food on the absorption and pharmacokinetics of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2013
)
0.63
" Independent of food and formulation, pharmacokinetic parameters of doses up to 10 mg rivaroxaban were dose proportional and had high oral bioavailability (≥ 80%)."( The effect of food on the absorption and pharmacokinetics of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2013
)
0.85
" Though the anticoagulation efficacy of these NOACs has been characterized, differences in their pharmacokinetic and pharmacodynamic profiles have become a significant consideration in terms of drug selection and dosing."( Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban.
Gong, IY; Kim, RB, 2013
)
0.6
" The oral, direct Factor Xa inhibitor rivaroxaban has been approved in adult patients for several thromboembolic disorders, and its well-defined pharmacokinetic and pharmacodynamic characteristics and efficacy and safety profiles in adults warrant further investigation of this agent in the paediatric population."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.9
"The objective of this study was to develop and qualify a physiologically based pharmacokinetic (PBPK) model for rivaroxaban doses of 10 and 20 mg in adults and to scale this model to the paediatric population (0-18 years) to inform the dosing regimen for a clinical study of rivaroxaban in paediatric patients."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.84
" The pharmacokinetic properties of rivaroxaban in virtual populations of children were simulated for two body weight-related dosing regimens equivalent to 10 and 20 mg once daily in adults."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.91
" However, pharmacokinetic values in infants and preschool children (body weight <40 kg) were lower than the 90 % confidence interval threshold of the adult reference model and, therefore, indicated that doses in these groups may need to be increased to achieve the same plasma levels as in adults."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.63
" Variability in the pharmacokinetic parameters is moderate (coefficient of variation 30-40 %)."( Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2014
)
0.65
" The introduction of newer oral anticoagulants, such as rivaroxaban, that are convenient to administer and have predictable pharmacokinetic and pharmacodynamic profiles, could ultimately simplify patient management in clinical practice and may improve clinical outcomes across a broad range of thromboembolic disorders."( Pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor.
Kreutz, R, 2014
)
0.91
"To review pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs) involving new oral anticoagulants for atrial fibrillation."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.39
"Articles reviewed focused on drugs affecting the permeability glycoprotein (P-gp) efflux transporter protein and/or cytochrome P (CYP) 450 3A4 enzymes, and pharmacodynamic DDIs when drugs are administered concomitantly."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.39
"This study investigated relevant pharmacodynamic and pharmacokinetic parameters during the transition from warfarin to rivaroxaban in healthy male subjects."( Pharmacodynamics and pharmacokinetics during the transition from warfarin to rivaroxaban: a randomized study in healthy subjects.
Becka, M; Krätzschmar, J; Kubitza, D; Mück, W, 2014
)
0.84
" POCT for aPTT is sensitive to increased concentrations of dabigatran, whereas the PT-POCT assessed with test systems such as the GEM PCL Plus may be helpful to measure the pharmacodynamic anticoagulant effects of rivaroxaban in emergency clinical situations."( Point-of-care coagulation testing for assessment of the pharmacodynamic anticoagulant effect of direct oral anticoagulant.
Herrmann, E; Herth, N; Kasper, A; Lindhoff-Last, E; Linnemann, B; Mani, H; Pfeilschifter, W; Schuettfort, G; Weil, Y; Wendt, T, 2014
)
0.59
" Rivaroxaban population pharmacokinetic (PK)/pharmacodynamic (PD) modeling data from ROCKET AF patients (n = 161) are reported and are used to confirm established rivaroxaban PK and PK/PD models and to re-estimate values of the models' parameters for the current AF population."( Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF.
Becker, RC; Califf, RM; Fox, KA; Girgis, IG; Halperin, JL; Mahaffey, KW; Moore, KT; Nessel, CC; Patel, MR; Peters, GR, 2014
)
1.56
" When combined, the co-administration of rivaroxaban 10 mg with SS erythromycin in subjects with mild or moderate RI produced mean increases in rivaroxaban AUC∞ and Cmax of approximately 76% and 56%, and 99% and 64%, respectively, relative to NRF subjects, with PD changes displaying a similar trend."( An open-label study to estimate the effect of steady-state erythromycin on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban in subjects with renal impairment and normal renal function.
Ariyawansa, J; Haskell, L; Moore, KT; Natarajan, J; Turner, KC; Vaidyanathan, S, 2014
)
0.87
" These regimens were devised based on the results of phase II dose-finding studies and/or pharmacokinetic modeling, and were demonstrated to be successful in randomized, phase III studies."( Clinical use of rivaroxaban: pharmacokinetic and pharmacodynamic rationale for dosing regimens in different indications.
Dobesh, PP; Trujillo, T, 2014
)
0.75
" Intensive structure-activity relationship (SAR) and structure-pharmacokinetic relationship (SPR) studies on this new series led to the discovery of compound 11a: a highly potent, selective, direct, and orally bioavailable FXa inhibitor with excellent in vivo antithrombotic efficacy and preferable pharmacokinetic profiles."( Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
Chen, X; Chu, W; Ding, S; Gong, G; Guo, B; Sun, P; Wang, H; Wang, Y; Xue, T; Yang, Y; Zhou, Y, 2014
)
0.4
"The primary objective was to explore the pharmacodynamic changes during transition from rivaroxaban to warfarin in healthy subjects."( Switching from rivaroxaban to warfarin: an open label pharmacodynamic study in healthy subjects.
Ariyawansa, J; Byra, W; Moore, KT; Natarajan, J; Salih, H; Turner, KC; Vaidyanathan, S, 2015
)
0.99
"The combined pharmacodynamic effects during co-administration of rivaroxaban and warfarin were greater than additive, but the pharmacokinetics of both drugs were unaffected."( Switching from rivaroxaban to warfarin: an open label pharmacodynamic study in healthy subjects.
Ariyawansa, J; Byra, W; Moore, KT; Natarajan, J; Salih, H; Turner, KC; Vaidyanathan, S, 2015
)
1.01
" To support the possibility that patients may choose to switch treatment from another nonvitamin K antagonist oral anticoagulant to edoxaban, this clinical study was conducted to evaluate the pharmacokinetic and pharmacodynamic effects of edoxaban after switching from rivaroxaban or dabigatran etexilate to edoxaban."( Pharmacokinetics and Pharmacodynamics of the Nonvitamin K Antagonist Oral Anticoagulant Edoxaban When Administered Alone or After Switching from Rivaroxaban or Dabigatran Etexilate in Healthy Subjects.
Brown, KS; Dishy, V; Kochan, J; Maa, JF; Parasrampuria, DA; Shi, M; Weilert, D, 2016
)
0.81
"Day 4 edoxaban pharmacokinetic parameters were similar for all treatments."( Pharmacokinetics and Pharmacodynamics of the Nonvitamin K Antagonist Oral Anticoagulant Edoxaban When Administered Alone or After Switching from Rivaroxaban or Dabigatran Etexilate in Healthy Subjects.
Brown, KS; Dishy, V; Kochan, J; Maa, JF; Parasrampuria, DA; Shi, M; Weilert, D, 2016
)
0.63
"This study aimed to characterize the single-dose pharmacokinetic (PK) and pharmacodynamic (PD) profile of rivaroxaban 15 mg administered before and after dialysis in subjects with end-stage renal disease (ESRD), and to compare this profile in subjects with ESRD to that in healthy control subjects (creatinine clearance ≥80 ml/min)."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Rivaroxaban in Chronic Hemodialysis.
Ariyawansa, J; Dias, C; Mills, RM; Moore, KT; Murphy, J; Smith, W; Weir, MR, 2016
)
0.89
" The objective of this phase 1 clinical trial was to investigate pharmacokinetic and pharmacodynamic (PK/PD) parameters of rivaroxaban in bariatric patients."( Pharmacokinetics and pharmacodynamics of single doses of rivaroxaban in obese patients prior to and after bariatric surgery.
Alberio, L; Altmeier, J; Borbély, YM; Candinas, D; Kröll, D; Lai, DLL; Nett, PC; Schädelin, S; Stirnimann, G; Vogt, A, 2017
)
0.91
" Mean rivaroxaban area under plasma concentration-time curve, peak plasma concentration, time to peak plasma concentration and terminal half-life were 971."( Pharmacokinetics and pharmacodynamics of single doses of rivaroxaban in obese patients prior to and after bariatric surgery.
Alberio, L; Altmeier, J; Borbély, YM; Candinas, D; Kröll, D; Lai, DLL; Nett, PC; Schädelin, S; Stirnimann, G; Vogt, A, 2017
)
1.18
" To quantify the impacts of concomitant verapamil administration and renal impairment on rivaroxaban pharmacokinetics, a minimal physiologically based pharmacokinetic model system was developed and used to evaluate potential increases in rivaroxaban exposure and the consequent increase in risk of major bleeding."( Minimal Physiologically Based Pharmacokinetic and Drug-Drug-Disease Interaction Model of Rivaroxaban and Verapamil in Healthy and Renally Impaired Subjects.
Chow, CR; Ismail, M; Lee, VH; Rubino, CM, 2018
)
0.92
" The present study is to develop a physiologically based pharmacokinetic (PBPK) model to predict several scenarios in clinical practice."( Application of physiologically based pharmacokinetic modeling to the prediction of drug-drug and drug-disease interactions for rivaroxaban.
Ge, W; Jiang, Q; Xu, R, 2018
)
0.69
" Population pharmacokinetic studies in older patients with thromboembolic diseases suggest a moderate effect of increasing age on rivaroxaban clearance, albeit not clinically significant."( Influence of age on the pharmacokinetics, pharmacodynamics, efficacy, and safety of rivaroxaban.
Foody, J; Moore, KT; Pan, G; Wong, P; Zhang, L, 2018
)
0.91
"There have been no animal experiments and clinical studies on the pharmacokinetic interaction between rivaroxaban and enalapril."( Simultaneous Determination of Rivaroxaban and Enalapril in Rat Plasma by UPLC-MS/MS and Its Application to A Pharmacokinetic Interaction Study.
Guo, J; Luo, SB; Mei, YB; Tong, LJ; Ye, XY; Zhang, Q; Zheng, S, 2019
)
1.02
"The UPLC-MS/MS method was successfully applied to simultaneous determination of rivaroxaban and enalapril in rat plasma and applied to study the pharmacokinetic interaction between rivaroxaban and enalapril."( Simultaneous Determination of Rivaroxaban and Enalapril in Rat Plasma by UPLC-MS/MS and Its Application to A Pharmacokinetic Interaction Study.
Guo, J; Luo, SB; Mei, YB; Tong, LJ; Ye, XY; Zhang, Q; Zheng, S, 2019
)
1.03
" The pharmacokinetic characteristics of available DOACs (dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban) differ substantially as regards oral bioavailability, plasma protein binding and the relative involvement of renal and non-renal elimination."( Clinical Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants in Patients with Renal Failure.
Padrini, R, 2019
)
0.75
" The pharmacokinetics in patients treated with standard and reduced doses of the four anticoagulants using liquid chromatography-tandem mass spectrometry was compared with the concentration ranges estimated using physiologically based pharmacokinetic modeling."( Pharmacokinetics of anticoagulants apixaban, dabigatran, edoxaban and rivaroxaban in elderly Japanese patients with atrial fibrillation treated in one general hospital.
Endo, S; Kishi, H; Kogiku, M; Noda, M; Notsu, Y; Ota, M; Shimizu, M; Takekawa, M; Yamazaki, H; Yamazaki-Nishioka, M, 2019
)
0.75
"A one-compartment PK model with first-order absorption adequately described the pharmacokinetic data."( Downregulation of ABCB1 gene in patients with total hip or knee arthroplasty influences pharmacokinetics of rivaroxaban: a population pharmacokinetic-pharmacodynamic study.
Grabnar, I; Mrhar, A; Petre, M; Pišlar, M; Potočnik, U; Repnik, K; Vogrin, M; Zdovc, J, 2019
)
0.73
"Prothrombin time (PT) is a measure of coagulation status and was assessed in the majority of patients in the rivaroxaban phase II and III clinical trials as a pharmacodynamic marker."( Enhancing the Quality of Rivaroxaban Exposure Estimates Using Prothrombin Time in the Absence of Pharmacokinetic Sampling.
Berkowitz, SD; Frede, M; Garmann, D; Hermanowski-Vosatka, A; Kubitza, D; Mueck, W; Solms, A; Spiro, TE; Willmann, S; Yan, X; Zhang, L, 2019
)
1.03
" Upon systematic model verification, physiologically based pharmacokinetic (PBPK) models are qualified for the quantitative rationalization of complex drug-drug-disease interactions (DDDIs)."( Systematic Development and Verification of a Physiologically Based Pharmacokinetic Model of Rivaroxaban.
Chan, ECY; Cheong, EJY; Chua, DXY; Teo, DWX, 2019
)
0.73
" However, real-world data that indicate pharmacokinetic (PK) parameters are comparable at the extremes of body size are lacking."( Fixed dose rivaroxaban can be used in extremes of bodyweight: A population pharmacokinetic analysis.
Arya, R; Barsam, S; Bartoli-Abdou, J; Brown, A; Byrne, R; Czuprynska, J; Duffy, S; Gazes, A; Gee, E; Green, B; Patel, JP; Patel, R; Patel, RK; Roberts, LN; Scott, V; Speed, V; Vadher, B; Woolcombe, S, 2020
)
0.95
" Physiologically-based pharmacokinetic models for apixaban and rivaroxaban were developed to estimate the net effect of CYP3A induction, P-gp inhibition, and P-gp induction by rifampicin."( Physiologically-Based Pharmacokinetic Modeling for the Prediction of a Drug-Drug Interaction of Combined Effects on P-glycoprotein and Cytochrome P450 3A.
Bonate, PL; Choules, MP; Komatsu, K; Otsuka, Y, 2020
)
0.8
" This physiologically based pharmacokinetic (PBPK) study investigated the pharmacokinetic behavior of rivaroxaban in clinical situations where drug clearance is impaired."( Applications of Physiologically Based Pharmacokinetic Modeling of Rivaroxaban-Renal and Hepatic Impairment and Drug-Drug Interaction Potential.
Coboeken, K; Fischer, K; Hügl, B; Kapsa, S; Mück, W; Mundhenke, M; Thelen, K; Willmann, S, 2021
)
1.07
" Bioanalytical methods for rivaroxaban quantification in plasma are necessary for application in pharmacokinetic studies, as well as in drug therapeutic monitoring."( Sensitive LC-MS/MS method for quantification of rivaroxaban in plasma: Application to pharmacokinetic studies.
Antônio, MA; Carvalho, PO; Cirino, JPG; Coelho, EC; Davanço, MG; de Campos, DR; de Oliveira, AC; Porcari, AM; Sanches, PHG, 2021
)
1.17
" There have been limited studies comparing the potential for pharmacokinetic (PK) drug interactions between different anticoagulants."( Comparison of potential pharmacokinetic drug interactions in patients with atrial fibrillation and changing from warfarin to non-vitamin K oral anticoagulant therapy.
Anoopkumar-Dukie, S; Badrick, T; Bernaitis, N, 2021
)
0.62
" The prothrombin time (PT), activated partial thromboplastin time (APTT), and levels of anti-Xa activity were tested as pharmacodynamic parameters in plasma samples."( Target Drug-Calibrated Anti-Xa Activity Assays and Expected Peak-Trough Levels in an Asian Population: A Multicenter Study.
Cui, Y; Jiang, J; Liu, Z; Mu, G; Wang, Z; Xiang, Q; Xie, Q; Zhang, H; Zhou, S, 2021
)
0.62
" Pharmacokinetic data were available in 94% (132/140) of patients."( Pharmacokinetics of Direct Oral Anticoagulants in Emergency Situations: Results of the Prospective Observational RADOA-Registry.
Beyer-Westendorf, J; Birschmann, I; Greinacher, A; Grottke, O; Herrmann, E; Konstantinides, S; Kuhn, J; Lindau, S; Lindhoff-Last, E; Lucks, J; Meybohm, P; Nowak-Göttl, U; Schellong, S; Sümnig, A; von Heymann, C; Zydek, B, 2022
)
0.72
" Physiologically-based pharmacokinetic (PBPK) and population pharmacokinetic (PopPK) modeling were used throughout the pediatric development of rivaroxaban according to the learn-and-confirm paradigm."( Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically-based pharmacokinetic predictions.
Coboeken, K; Drenth, HJ; Ince, I; Kubitza, D; Lensing, AWA; Lippert, J; Mayer, H; Mesic, E; Mück, W; Thelen, K; Willmann, S; Yang, H; Zhang, Y; Zhu, P, 2021
)
1.09
" The DOACs' peak and trough plasma levels obtained from our study population were compared with those sourced from pharmacokinetic studies among patients without obesity, defined as a normal reference range in the literature."( Pharmacokinetics of Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Extreme Obesity.
Atripaldi, U; Bottino, R; Cattaneo, D; Clementi, E; Giannetti, L; Laezza, N; Russo, V, 2021
)
0.62
" A previously verified physiologically-based pharmacokinetic (PBPK) model of rivaroxaban established how its multiple pathways of elimination via both CYP3A4/2J2-mediated hepatic metabolism and organic anion transporter 3 (OAT3)/P-glycoprotein-mediated renal secretion predisposes rivaroxaban to drug-drug-disease interactions (DDDIs) with clinically relevant protein kinase inhibitors (PKIs)."( Application of a physiologically based pharmacokinetic model of rivaroxaban to prospective simulations of drug-drug-disease interactions with protein kinase inhibitors in cancer-associated venous thromboembolism.
Chan, ECY; Cheong, EJY; Chin, SY; Ng, DZW; Wang, Z, 2022
)
1.19
"We aimed to report outcome and pharmacokinetic parameters in patients who massively ingested DOACs."( Case series of massive direct oral anticoagulant ingestion-Treatment and pharmacokinetics data.
Camoin-Jau, L; Chevillard, L; Delrue, M; Deye, N; Dragoni, A; Gainnier, M; Malissin, I; Mégarbane, B; Siguret, V; Stépanian, A; Voicu, S, 2022
)
0.72
"This investigation was a substudy analysis conducted in selected cohorts of patients with stable atherosclerotic disease enrolled from a larger prospective, open-label, parallel-group pharmacodynamic (PD) study."( Platelet P2Y12 inhibiting therapy in adjunct to vascular dose of rivaroxaban or aspirin: a pharmacodynamic study of dual pathway inhibition vs. dual antiplatelet therapy.
Angiolillo, DJ; Bass, TA; Been, L; Franchi, F; Galli, M; Geisler, T; Jaoude, PA; Jennings, LK; Jia, S; Lee, CH; Maaliki, N; Pineda, AM; Rivas, A; Rollini, F; Soffer, D; Suryadevara, S; Zenni, MM; Zhou, X, 2022
)
0.96
"Although predictable pharmacokinetic and pharmacodynamic of rivaroxaban allow fixed dosing regimens without routine coagulation monitoring, there is still the necessity to monitor and predict the effects of rivaroxaban in specific conditions and different populations."( Rivaroxaban population pharmacokinetic and pharmacodynamic modeling in Iranian patients.
Abdar Esfahani, M; Davoudian, A; Esmaeili, T; Omidfar, D; Rezaee, M; Rezaee, S, 2022
)
2.41
"A sequential nonlinear mixed effect pharmacokinetic/pharmacodynamic modeling method was used to establish the relation between rivaroxaban concentration and anti-factor Xa activity, prothrombin time, and activated partial thromboplastin time (aPTT) as pharmacodynamic biomarkers in a population of sixty-nine Iranian patients under treatment with oral rivaroxaban."( Rivaroxaban population pharmacokinetic and pharmacodynamic modeling in Iranian patients.
Abdar Esfahani, M; Davoudian, A; Esmaeili, T; Omidfar, D; Rezaee, M; Rezaee, S, 2022
)
2.37
"This review focuses on: 1) current recommendations for the management of pharmacokinetic DOAC DDIs and the evidence used to support them; 2) alterations in DOAC exposure in the setting of concomitant DDIs and mild, moderate, and severe renal impairment; 3) clinical outcomes associated with this combination; and 4) expert recommendations for the management of pharmacokinetic DOAC DDIs."( Evaluating pharmacokinetic drug-drug interactions of direct oral anticoagulants in patients with renal dysfunction.
Hanigan, S; Park, JM, 2022
)
0.72
"Given the lack of supporting clinical data, empiric dose adjustments based on pharmacokinetic data alone should be avoided."( Evaluating pharmacokinetic drug-drug interactions of direct oral anticoagulants in patients with renal dysfunction.
Hanigan, S; Park, JM, 2022
)
0.72
" Further studies using physiologically based pharmacokinetic modelling are required to investigate the drug-drug interactions between these drugs."( Simvastatin, but Not Atorvastatin, Is Associated with Higher Peak Rivaroxaban Serum Levels and Bleeding: an Asian Cohort Study from Singapore.
Chan, ECY; Soh, XQ; Tan, DS, 2023
)
1.15
" Population pharmacokinetic (PopPK) analyses can help in identifying such factors while providing predictive models."( Population Pharmacokinetic Models for Direct Oral Anticoagulants: A Systematic Review and Clinical Appraisal Using Exposure Simulation.
Csajka, C; Daali, Y; Fontana, P; Gaspar, F; Guidi, M; Reny, JL; Terrier, J, 2022
)
0.72
" We aimed to apply physiologically-based pharmacokinetic (PBPK) modeling to simulate the complex drug-drug interactions (DDIs) of ritonavir with two anticoagulants, rivaroxaban and racemic warfarin, to address this important clinical conundrum."( Physiologically-Based Pharmacokinetic Modeling-Guided Dose Management of Oral Anticoagulants when Initiating Nirmatrelvir/Ritonavir (Paxlovid) for COVID-19 Treatment.
Chan, ECY; Wang, Z, 2022
)
0.92
"Population pharmacokinetic (PK)/pharmacodynamic models are commonly used to inform drug dosing; however, often real-world patients are not well represented in the clinical trial population."( Leveraging a Previously Published Population Pharmacokinetic Model to Predict Rivaroxaban Exposure in Real-World Patients.
Campbell, KB; Gehi, A; Gonzalez, D; Kashuba, ADM; Konicki, R; Moll, S; Patterson, JH; Powell, JR; Qaraghuli, FA; Tyson, R; Weiner, D, 2022
)
0.95
" The developed dronedarone physiologically based pharmacokinetic (PBPK) model was verified using reported drug-drug interactions (DDIs) between dronedarone and CYP3A4 and P-gp substrates."( Predicting drug-drug interactions with physiologically based pharmacokinetic/pharmacodynamic modelling and optimal dosing of apixaban and rivaroxaban with dronedarone co-administration.
He, QF; Jiao, Z; Wen, HN; Xiang, XQ; Yu, JG, 2022
)
0.92
" We also discuss the available pharmacodynamic (PD) evidence and clinical implications with the use of DPI in patients with atherosclerotic disease."( Dual pathway inhibition in patients with atherosclerotic disease: pharmacodynamic considerations and clinical implications.
Angiolillo, DJ; D'Amario, D; De Caterina, R; Franchi, F; Galli, M; Gibson, CM; Mehran, R; Ortega-Paz, L; Rollini, F, 2023
)
0.91
" We aimed to develop, verify and validate a physiologically based pharmacokinetic (PBPK) model of dronedarone and its major metabolite, N-desbutyldronedarone (NDBD), to prospectively interrogate this clinically relevant DDI in healthy and mild renal impairment populations."( Development and verification of a physiologically based pharmacokinetic model of dronedarone and its active metabolite N-desbutyldronedarone: Application to prospective simulation of complex drug-drug interaction with rivaroxaban.
Ang, XJ; Chan, ECY; Leow, JWH, 2023
)
1.1
" Yet, potentially major pharmacokinetic drug-drug interactions have been identified as a reason to withhold DOACs and to rather choose an alternative."( Pharmacokinetic drug-drug interactions with direct anticoagulants in the management of cancer-associated thrombosis.
Van Aelst, L; Van Cutsem, E; Van der Linden, L; Vanassche, T; Verhamme, P, 2023
)
0.91
" Accordingly, a physiologically-based pharmacokinetic (PBPK) analysis was performed to predict the magnitude of DDI on apixaban and rivaroxaban exposures in the presence of 160 mg once-daily dosing of enzalutamide."( Physiologically-based pharmacokinetic modeling to predict drug-drug interaction of enzalutamide with combined P-gp and CYP3A substrates.
Bonate, PL; Jamei, M; Minematsu, T; Otsuka, Y; Poondru, S; Rose, RH; Ushigome, F, 2023
)
1.11
" A physiologically based pharmacokinetic model (PBPK) and observed exposure-risk relationship predicted an increased bleeding risk induced by rivaroxaban (RXB) in patients with mild to moderate chronic kidney disease (CKD) taking concomitant medications that are combined Pgp-CYP3A inhibitors."( Coming full circle: The potential utility of real-world evidence to discern predictions from a physiologically based pharmacokinetic model.
Grillo, JA; McNair, D; Zhao, P, 2023
)
1.11

Compound-Compound Interactions

By January 19, 2020, 2309 fatal adverse event reports of rivaroxaban combined with aspirin from 21 countries were entered in VigiBase. The aim of this study was to analyze the clinical characteristics of fatal adverse events (AEs) and to underline the importance of the rational use of drugs.

ExcerptReferenceRelevance
"To evaluate potential drug-drug interactions with rivaroxaban in patients undergoing total hip replacement (THR) and total knee replacement (TKR) surgeries."( Drug interactions with rivaroxaban following total joint replacement surgery.
Kwong, LM; Tong, LM, 2012
)
0.94
" A Phase 2 study that evaluated several doses and administration intervals of rivaroxaban in combination with aspirin or both aspirin and clopidogrel in patients with acute coronary syndrome found that clinically significant bleeding events occurred in patients receiving rivaroxaban 10 mg daily (the dose approved for the orthopedic indication)."( Drug interactions with rivaroxaban following total joint replacement surgery.
Kwong, LM; Tong, LM, 2012
)
0.92
"Phase 1 drug-drug interaction studies in healthy humans provided little insight into the pharmacodynamic drug interactions between rivaroxaban and NSAIDs or antiplatelet agents."( Drug interactions with rivaroxaban following total joint replacement surgery.
Kwong, LM; Tong, LM, 2012
)
0.89
"To review pharmacokinetic and pharmacodynamic drug-drug interactions (DDIs) involving new oral anticoagulants for atrial fibrillation."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.39
" Phase I DDI studies have reported pharmacokinetic DDIs mediated by P-gp alone (dabigatran etexilate) or in combination with CYP3A4 enzymes (rivaroxaban and apixaban)."( Pharmacokinetic and pharmacodynamic drug interactions with new oral anticoagulants: what do they mean for patients with atrial fibrillation?
Gulseth, M; Hellwig, T, 2013
)
0.59
" The objective of this study was to determine the efficacy and safety of endoscopy combined with the administration of antiplatelet and/or anticoagulant agents to stimulate bleeding in order to define a source."( Pharmacologic provocation combined with endoscopy in refractory cases of GI bleeding.
Adler, DG; Jex, KT; Nicaud, MJ; Raines, DL, 2017
)
0.46
"Provocative testing combined with endoscopy can be justified as an option in the diagnostic algorithm of complex cases of GI bleeding when intermittent bleeding related to a vascular lesion, such as an angioectasia or Dieulafoy, is suspected."( Pharmacologic provocation combined with endoscopy in refractory cases of GI bleeding.
Adler, DG; Jex, KT; Nicaud, MJ; Raines, DL, 2017
)
0.46
" Currently, however, clinical data on the extent of these postulated drug-drug interactions are lacking."( Application of Static Modeling --in the Prediction of In Vivo Drug-Drug Interactions between Rivaroxaban and Antiarrhythmic Agents Based on In Vitro Inhibition Studies.
Chan, EC; Cheong, EJ; Chiu, GN; Goh, JJ; Hong, Y; Kojodjojo, P; Liu, Y; Venkatesan, G, 2017
)
0.67
" Data from a phase 1, drug-drug interaction study were used to qualify the minimal physiologically based pharmacokinetic model system."( Minimal Physiologically Based Pharmacokinetic and Drug-Drug-Disease Interaction Model of Rivaroxaban and Verapamil in Healthy and Renally Impaired Subjects.
Chow, CR; Ismail, M; Lee, VH; Rubino, CM, 2018
)
0.7
" Hepatic clearance and drug-drug interactions (DDI) were estimated by in vitro in vivo extrapolation (IVIVE) based on parameters obtained from in vitro experiments."( Application of physiologically based pharmacokinetic modeling to the prediction of drug-drug and drug-disease interactions for rivaroxaban.
Ge, W; Jiang, Q; Xu, R, 2018
)
0.69
" This work aimed to assess potential P-gp-mediated drug-drug interactions between PDE5is and DOACs using in vitro methods."( In Vitro Assessment of Pharmacokinetic Drug-Drug Interactions of Direct Oral Anticoagulants: Type 5-Phosphodiesterase Inhibitors Are Inhibitors of Rivaroxaban and Apixaban Efflux by P-Glycoprotein.
Bertoletti, L; Delavenne, X; Delézay, O; Hodin, S; Jacqueroux, E; Margelidon-Cozzolino, V, 2018
)
0.68
"The aim of this study is to assess patterns of potential drug-drug interactions (DDIs) with direct oral anticoagulants (DOACs) in an inpatient hospital setting."( Evaluation of Potential Drug-Drug Interactions With Direct Oral Anticoagulants in a Large Urban Hospital.
Karakas-Torgut, A; Mo, Y; Pham, AQ, 2020
)
0.56
" NOAC have also been studied in combination with platelet antiaggregation in both patients with coronary and peripheral arterial disease, and reduced doses will presumably emerge as routine treatment also in these conditions."( [NOAC in combination with platelet antiaggregation in both patients with coronary and peripheral arterial disease].
Gottsäter, A, 2018
)
0.48
" To evaluate drug-drug interactions, the impact of ketoconazole, a known strong inhibitor of cytochrome P450 3A4 and P-glycoprotein, was studied."( Microdosed Cocktail of Three Oral Factor Xa Inhibitors to Evaluate Drug-Drug Interactions with Potential Perpetrator Drugs.
Burhenne, J; Foerster, KI; Haefeli, WE; Lehmann, ML; Mikus, G; Schaumaeker, M, 2019
)
0.51
" This is the first study that has been conducted to evaluate drug-drug interactions with a drug class, and the low administered doses also allow evaluation in vulnerable target populations."( Microdosed Cocktail of Three Oral Factor Xa Inhibitors to Evaluate Drug-Drug Interactions with Potential Perpetrator Drugs.
Burhenne, J; Foerster, KI; Haefeli, WE; Lehmann, ML; Mikus, G; Schaumaeker, M, 2019
)
0.51
" The aim of the present study was to investigate the effects of the potent P-gp inhibitor ciclosporin and its combination with the moderate CYP3A inhibitor fluconazole on rivaroxaban pharmacokinetics and on CYP3A activity."( Perpetrator effects of ciclosporin (P-glycoprotein inhibitor) and its combination with fluconazole (CYP3A inhibitor) on the pharmacokinetics of rivaroxaban in healthy volunteers.
Brings, A; Burhenne, J; Czock, D; Foerster, KI; Haefeli, WE; Lehmann, ML; Weiss, J, 2019
)
0.91
" Ciclosporin combined with fluconazole increased rivaroxaban average exposure by 86% (58-119%) and maximum concentration by 115% (83-153%), which was considerably stronger than observed in historical controls receiving rivaroxaban with fluconazole alone, and decreased CYP3A4 activity by 79% (76-82%)."( Perpetrator effects of ciclosporin (P-glycoprotein inhibitor) and its combination with fluconazole (CYP3A inhibitor) on the pharmacokinetics of rivaroxaban in healthy volunteers.
Brings, A; Burhenne, J; Czock, D; Foerster, KI; Haefeli, WE; Lehmann, ML; Weiss, J, 2019
)
0.97
"Patients treated with rivaroxaban in combination with single modulators of multiple elimination pathways or multiple modulators of single elimination pathways (CYP3A, P-gp) require particular care."( Perpetrator effects of ciclosporin (P-glycoprotein inhibitor) and its combination with fluconazole (CYP3A inhibitor) on the pharmacokinetics of rivaroxaban in healthy volunteers.
Brings, A; Burhenne, J; Czock, D; Foerster, KI; Haefeli, WE; Lehmann, ML; Weiss, J, 2019
)
1.03
"As an alternative to vitamin K antagonists (VKAs), direct oral anticoagulants (DOACs) are increasingly prescribed in combination with riociguat in the treatment of chronic thromboembolic pulmonary hypertension (CTEPH)."( In vitro assessment of P-gp and BCRP transporter-mediated drug-drug interactions of riociguat with direct oral anticoagulants.
Bertoletti, L; Delavenne, X; Hodin, S; Jacqueroux, E; Margelidon-Cozzolino, V; Mercier, C, 2020
)
0.56
"Tranexamic acid (TXA) combined with rivaroxaban (RA) has been widely used in total knee replacement (TKA)."( Efficacy and Safety of Tranexamic Acid Combined with Rivaroxaban in Primary Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials.
Du, C; Liu, Z; Ma, J; Meng, B; Zhang, G, 2021
)
1.15
"The application of TXA combined with RA in the TKA can effectively reduce blood loss without increasing the risk of DVT."( Efficacy and Safety of Tranexamic Acid Combined with Rivaroxaban in Primary Total Knee Arthroplasty: A Meta-Analysis of Randomized Controlled Trials.
Du, C; Liu, Z; Ma, J; Meng, B; Zhang, G, 2021
)
0.87
"Using 3 different perpetrators the impact of voriconazole, cobicistat and rifampicin (single dose), we evaluated the suitability of a microdose cocktail of factor Xa inhibitors (FXaI; rivaroxaban, apixaban and edoxaban; 100 μg in total) to study drug-drug interactions."( Application of a microdosed cocktail of 3 oral factor Xa inhibitors to study drug-drug interactions with different perpetrator drugs.
Burhenne, J; Foerster, KI; Haefeli, WE; Lehmann, ML; Mikus, G; Schaumaeker, M, 2020
)
0.75
" This is a safe approach to concurrently study drug-drug interactions with a drug class."( Application of a microdosed cocktail of 3 oral factor Xa inhibitors to study drug-drug interactions with different perpetrator drugs.
Burhenne, J; Foerster, KI; Haefeli, WE; Lehmann, ML; Mikus, G; Schaumaeker, M, 2020
)
0.56
" Upon scrutiny of the patient's medical history, a drug-drug interaction between amiodarone and rivaroxaban persisting 3 weeks after cessation of amiodaron remains the prime suspect causing the clinical picture."( Supratheraputic rivaroxaban levels: A persistent drug-drug interaction after discontinuation of amiodarone.
Dorff, MH; Falskov, B; Jensen, EA; Skov, K, 2020
)
1.12
"Objectives For revealing the peculiarities of the drug-drug interaction of rivaroxaban (substrate CYP3A4 and P-gp) and calcium channel blockers (CCBs) (verapamil - inhibitor CYP3A4 and P-gp and amlodipine - substrate CYP3A4) in patients 80 years and older with nonvalvular atrial fibrillation (NAF) we studied 128 patients."( Drug-drug interaction of rivaroxaban and calcium channel blockers in patients aged 80 years and older with nonvalvular atrial fibrillation.
Bahteeva, D; Bochkov, P; Cherniaeva, M; Golovina, O; Gorbatenkova, S; Kulikova, M; Mirzaev, K; Ostroumova, O; Rytkin, E; Shevchenko, R; Sychev, D, 2020
)
1.09
" The models were verified with observed clinical drug-drug interactions with CYP3A and P-gp inhibitors."( Physiologically-Based Pharmacokinetic Modeling for the Prediction of a Drug-Drug Interaction of Combined Effects on P-glycoprotein and Cytochrome P450 3A.
Bonate, PL; Choules, MP; Komatsu, K; Otsuka, Y, 2020
)
0.56
" Therefore, renal and hepatic impairment may reduce rivaroxaban clearance, and medications inhibiting these clearance pathways could lead to drug-drug interactions."( Applications of Physiologically Based Pharmacokinetic Modeling of Rivaroxaban-Renal and Hepatic Impairment and Drug-Drug Interaction Potential.
Coboeken, K; Fischer, K; Hügl, B; Kapsa, S; Mück, W; Mundhenke, M; Thelen, K; Willmann, S, 2021
)
1.11
"Concomitant use of rivaroxaban with AADs appears to be well tolerated, warranting further investigation into the apparent benefits of a reduced dose of rivaroxaban combined with dronedarone."( Safety and Effectiveness of Rivaroxaban in Combination with Various Antiarrhythmic Drugs in Patients with Non-Permanent Atrial Fibrillation.
Chen, CY; Chiou, WR; Chuang, JY; Huang, CC; Kuo, JY; Lee, YH; Liao, FC; Lin, PL; Liu, LY; Su, MI; Tsai, CT; Wu, YJ, 2021
)
1.24
"Dexamethasone has the potential to interact with the DOACs via CYP3A4 and/or P-gp induction."( Potential Dexamethasone-Direct Oral Anticoagulant Drug Interaction: Is This a Concern in COVID?
Burns, C; Garwood, CL; Liu, Q; Smythe, MA, 2022
)
0.72
"In vitro evaluation of the P-glycoprotein (P-gp) inhibitory potential is an important issue when predicting clinically relevant drug-drug interactions (DDIs)."( In Vitro Evaluation of P-gp-Mediated Drug-Drug Interactions Using the RPTEC/TERT1 Human Renal Cell Model.
Bin, V; Delavenne, X; Hodin, S; Ollier, E; Saib, S, 2022
)
0.72
" The aim of this study was to assess the potential P-gp-mediated drug-drug interactions between 11 tyrosine kinase inhibitors (TKIs) with apixaban and rivaroxaban."( Tyrosine kinase inhibitors and direct oral anticoagulants: In vitro evaluation of drug-drug interaction mediated by P-glycoprotein.
Bertoletti, L; Bin, V; Delavenne, X; Hodin, S; Lafaie, L; Saïb, S, 2022
)
0.92
"To explore the cohort study of rivaroxaban combined with D-dimer dynamic monitoring in the prevention of deep venous thrombosis (DVT) after knee arthroplasty."( A Cohort Study of Rivaroxaban Combined with D-Dimer Dynamic Monitoring in the Prevention of Deep Venous Thrombosis after Knee Arthroplasty.
Cui, Y; Dong, Y; Duan, G; Ru, J; Wang, H, 2022
)
1.34
"Rivaroxaban combined with D-dimer dynamic monitoring has high clinical value in preventing DVT after knee arthroplasty and can effectively reduce the amount of blood loss during operation and the incidence of postoperative DVT, PE, and bleeding complications, which is worth popularizing to reduce the area of ecchymosis and the degree of pain after operation and shorten the recovery process."( A Cohort Study of Rivaroxaban Combined with D-Dimer Dynamic Monitoring in the Prevention of Deep Venous Thrombosis after Knee Arthroplasty.
Cui, Y; Dong, Y; Duan, G; Ru, J; Wang, H, 2022
)
2.5
" Recommendations for DOAC drug-drug interactions (DDIs) by the product labeling are limited to selected CYP3A4 and P-glycoprotein inhibitors and lack considerations for concomitant renal dysfunction."( Evaluating pharmacokinetic drug-drug interactions of direct oral anticoagulants in patients with renal dysfunction.
Hanigan, S; Park, JM, 2022
)
0.72
" Both warfarin and direct oral anticoagulants are susceptible to drug-drug interactions (DDIs)."( Drug Interactions Affecting Oral Anticoagulant Use.
Chung, MK; Dukes, J; Ezekowitz, MD; Gengler, BE; Gopinathannair, R; Lakkireddy, D; Lip, GYH; Mar, PL; Miletello, M; Noseworthy, PA; Olshansky, B; Perez, A; Reiffel, J; Tisdale, JE, 2022
)
0.72
"The aim of this study was to analyze the clinical characteristics of fatal adverse events (AEs) of rivaroxaban combined with aspirin and to underline the importance of the rational use of drugs."( Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase.
Ding, Q; Yan, S; Yue, QY; Zhang, Q, 2022
)
1.24
"By January 19, 2020, 2309 fatal adverse event reports of rivaroxaban combined with aspirin from 21 countries were entered in VigiBase."( Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase.
Ding, Q; Yan, S; Yue, QY; Zhang, Q, 2022
)
1.27
"Fatal AEs related to rivaroxaban combined with aspirin, including bleeding and ischemic events, have been reported mostly in the elderly, and sometimes involved medication errors."( Fatal adverse events of rivaroxaban combined with aspirin: an analysis using data from VigiBase.
Ding, Q; Yan, S; Yue, QY; Zhang, Q, 2022
)
1.35
" The developed dronedarone physiologically based pharmacokinetic (PBPK) model was verified using reported drug-drug interactions (DDIs) between dronedarone and CYP3A4 and P-gp substrates."( Predicting drug-drug interactions with physiologically based pharmacokinetic/pharmacodynamic modelling and optimal dosing of apixaban and rivaroxaban with dronedarone co-administration.
He, QF; Jiao, Z; Wen, HN; Xiang, XQ; Yu, JG, 2022
)
0.92
" We aim to systematically evaluate the safety and efficacy of TCM combined with Rivaroxaban in the treatment of lower limb DVT."( Efficacy of traditional Chinese medicine combined with rivaroxaban in the treatment of lower extremity deep vein thrombosis: A meta-analysis.
Adu, IK; Qi, G; Wu, H; Zheng, D; Zhu, M, 2022
)
1.2
"Nine RCTs with a total of 730 cases were included, 368 cases in the trial group were treated with TCM combined with Rivaroxaban, and 362 cases in the control group were treated with Rivaroxaban alone after surgery."( Efficacy of traditional Chinese medicine combined with rivaroxaban in the treatment of lower extremity deep vein thrombosis: A meta-analysis.
Adu, IK; Qi, G; Wu, H; Zheng, D; Zhu, M, 2022
)
1.18
"Based on the available evidence, TCM combined with Rivaroxaban for treating lower extremity DVT have better clinical efficacy and safety profile, reducing the risk of bleeding complications and adverse effects."( Efficacy of traditional Chinese medicine combined with rivaroxaban in the treatment of lower extremity deep vein thrombosis: A meta-analysis.
Adu, IK; Qi, G; Wu, H; Zheng, D; Zhu, M, 2022
)
1.22
"Direct oral anticoagulants (DOACs) can be involved in clinical relevant drug-drug interactions (DDIs) which may compromise safe and effective use."( Drug-drug interactions with direct oral anticoagulants: development of a consensus list for ambulatory care.
Boussery, K; Capiau, A; De Backer, T; De Bolle, L; Mehuys, E; Van Tongelen, I, 2023
)
0.91
" Clinical management of DDIs in Chinese older adults in the absence of complex polypharmacy can a priori be similar to the EHRA guideline but routine monitoring of bleeding risk is encouraged when dabigatran etexilate given with verapamil and clarithromycin."( Physiologically-based pharmacokinetic modeling to predict drug-drug interactions of dabigatran etexilate and rivaroxaban in the Chinese older adults.
Cui, C; Lai, X; Li, H; Liu, D; Sia, JEV; Wu, X; Zhang, F, 2023
)
1.12
"Despite potential enzyme- and transporter-mediated drug-drug interactions (DDIs) between dronedarone and rivaroxaban in atrial fibrillation (AF) patients, pharmacokinetic/pharmacodynamic data remain limited to guide clinical practice."( Development and verification of a physiologically based pharmacokinetic model of dronedarone and its active metabolite N-desbutyldronedarone: Application to prospective simulation of complex drug-drug interaction with rivaroxaban.
Ang, XJ; Chan, ECY; Leow, JWH, 2023
)
1.31
"Whether there are differences in direct oral anticoagulants efficacy and safety in patients with atrial fibrillation (AF) combined with hypertension is unclear."( Efficacy and Safety of Direct Oral Anticoagulants in Patients With Atrial Fibrillation Combined With Hypertension: A Multicenter, Retrospective Cohort Study.
Chen, X; Dai, H; Du, X; Gu, P; Guan, C; Huang, N; Huang, X; Li, R; Lin, X; Liu, X; Liu, Y; Lv, M; Wu, T; Xu, W; Zhang, J; Zhang, M; Zhang, W; Zheng, Q; Zhu, Z, 2023
)
0.91
" Yet, potentially major pharmacokinetic drug-drug interactions have been identified as a reason to withhold DOACs and to rather choose an alternative."( Pharmacokinetic drug-drug interactions with direct anticoagulants in the management of cancer-associated thrombosis.
Van Aelst, L; Van Cutsem, E; Van der Linden, L; Vanassche, T; Verhamme, P, 2023
)
0.91
" A clinical drug-drug interaction (DDI) study between enzalutamide and digoxin, a typical P-gp substrate, suggested enzalutamide has weak inhibitory effect on P-gp substrates."( Physiologically-based pharmacokinetic modeling to predict drug-drug interaction of enzalutamide with combined P-gp and CYP3A substrates.
Bonate, PL; Jamei, M; Minematsu, T; Otsuka, Y; Poondru, S; Rose, RH; Ushigome, F, 2023
)
0.91
" Some clinical and animal research revealed that AD combined with chronic cerebral hypoperfusion (CCH) exacerbates AD progression by inducing blood-brain barrier dysfunction and fibrinogen deposition."( Protective Effects of Rivaroxaban on White Matter Integrity and Remyelination in a Mouse Model of Alzheimer's Disease Combined with Cerebral Hypoperfusion.
Bian, Y; Bian, Z; Fukui, Y; Hu, X; Ishiura, H; Liu, X; Morihara, R; Sun, H; Yamashita, T; Yu, H, 2023
)
1.22

Bioavailability

Rivaroxaban is the first orally bioavailable direct factor Xa inhibitor. Its role in acute coronary syndrome is not fully understood. A novel self-nanoemulsifying drug delivery system (SNEDDS) was used to improve oral bioavailability.

ExcerptReferenceRelevance
" BAY 59-7939 was rapidly absorbed after oral dosing, with an absolute bioavailability of 57-66% in rats, and 60-86% in dogs."( Pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--in rats and dogs.
Buetehorn, U; Daehler, HP; Kohlsdorfer, C; Pleiss, U; Sandmann, S; Schlemmer, KH; Schwarz, T; Steinke, W; Weinz, C, 2005
)
0.33
" After oral administration the absorption is near 100%, the bioavailability is near 80%, and the elimination half-life is 5-9 hours with mixed excretion via the renal and fecal/biliary routes."( New compounds in the management of venous thromboembolism after orthopedic surgery: focus on rivaroxaban.
Borris, LC, 2008
)
0.57
" The main pharmacokinetic characteristics of rivaroxaban are a bioavailability of approximately 80-100%, a maximum concentration obtained in 2 to 4 hours, a terminal half-life of elimination of 7 to 11 hours, a renal elimination for 1/3 for the active hepatic metabolism from the cytochrome P450 (3A4) for the other 2/3."( [Rivaroxaban: clinical pharmacology].
Laporte, S; Mismetti, P, 2008
)
1.52
" A class of highly potent, selective, efficacious and orally bioavailable direct factor Xa inhibitors was discovered."( Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide, a highly potent, selective, and orally efficacious factor Xa inhibitor.
Arfsten, AE; Bao, L; Bauer, SM; Clizbe, LA; Edwards, ST; Fan, J; Goldman, EA; Hollenbach, SJ; Huang, W; Hutchaleelaha, A; Jia, ZJ; Kanter, J; Lambing, JL; Li, W; Pandey, A; Park, G; Probst, GD; Scarborough, RM; Sinha, U; Song, Y; Su, T; Wang, L; Wong, PW; Woolfrey, J; Wu, Y; Zhang, P; Zhu, BY, 2009
)
0.35
" Its oral bioavailability is low, but shows reduced interindividual variability."( [Pharmacokinetics and pharmacodynamics of the new oral anticoagulants dabigatran and rivaroxaban].
Climent Grana, E; Jover Botella, A; Ordovás Baines, JP; Valero García, I,
)
0.36
"Rivaroxaban is the first orally bioavailable direct factor Xa inhibitor and its role in acute coronary syndrome is not fully understood."( Rivaroxaban in the contemporary treatment of acute coronary syndromes.
Alexander, D; Jeremias, A, 2011
)
3.25
" PPIs can reduce the antiplatelet activity of clopidogrel through cytochrome P450 2C19 inhibition, and pantoprazole reduces the bioavailability of dabigatran, a direct thrombin inhibitor that acts via cytochrome P450 2C19-independent mechanisms."( Effect of multiple doses of omeprazole on the pharmacokinetics, pharmacodynamics, and safety of a single dose of rivaroxaban.
Ariyawansa, J; Burton, PB; Moore, KT; Plotnikov, AN; Thyssen, A; Vaccaro, N, 2011
)
0.58
" For a 10 mg dose, the oral bioavailability of rivaroxaban is high (80-100%) and is not affected by food intake."( Pharmacodynamic and pharmacokinetic basics of rivaroxaban.
Kreutz, R, 2012
)
0.89
" Its predictable pharmacokinetic profile, high oral bioavailability and once-daily dosing make rivaroxaban an optimal anticoagulant that warrants investigation in children."( The in vitro anticoagulant effect of rivaroxaban in children.
Attard, C; Ignjatovic, V; Kubitza, D; Monagle, P, 2012
)
0.87
" Study 1 was an absolute bioavailability study that compared 5 mg and 20 mg tablet doses with a 1 mg intravenous solution."( The effect of food on the absorption and pharmacokinetics of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2013
)
0.63
" Independent of food and formulation, pharmacokinetic parameters of doses up to 10 mg rivaroxaban were dose proportional and had high oral bioavailability (≥ 80%)."( The effect of food on the absorption and pharmacokinetics of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2013
)
0.85
"Pharmacokinetic parameters of doses up to 10 mg rivaroxaban were dose proportional and had high oral bioavailability independent of food or whether administered as tablet or solution."( The effect of food on the absorption and pharmacokinetics of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2013
)
0.89
" Oral bioavailability is high (80-100 %) for the 10 mg tablet irrespective of food intake and for the 15 mg and 20 mg tablets when taken with food."( Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban.
Becka, M; Kubitza, D; Mueck, W; Stampfuss, J, 2014
)
0.65
" It reaches maximal plasma concentration 2-4 hours after administration and has a high bioavailability (80-100%)."( Pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor.
Kreutz, R, 2014
)
0.67
" Its predictable pharmacokinetic profile, high oral bioavailability and once-daily dosing make rivaroxaban an optimal anticoagulant that warrants investigation in neonates."( The in-vitro anticoagulant effect of rivaroxaban in neonates.
Attard, C; Ignjatovic, V; Kubitza, D; Monagle, P, 2014
)
0.89
" Intensive structure-activity relationship (SAR) and structure-pharmacokinetic relationship (SPR) studies on this new series led to the discovery of compound 11a: a highly potent, selective, direct, and orally bioavailable FXa inhibitor with excellent in vivo antithrombotic efficacy and preferable pharmacokinetic profiles."( Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
Chen, X; Chu, W; Ding, S; Gong, G; Guo, B; Sun, P; Wang, H; Wang, Y; Xue, T; Yang, Y; Zhou, Y, 2014
)
0.4
"Concomitant medication with proton pump inhibitors, amiodarone, clarithromycin, and verapamil increased bioavailability whereas rifampicin decreased the bioavailability of dabigatran."( Relevance of P-glycoprotein in stroke prevention with dabigatran, rivaroxaban, and apixaban.
Finsterer, J; Stöllberger, C, 2015
)
0.65
" Assuming similar bioavailability between groups, this reflects an approximate 35% decrease in overall drug clearance in ESRD subjects."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Rivaroxaban in Chronic Hemodialysis.
Ariyawansa, J; Dias, C; Mills, RM; Moore, KT; Murphy, J; Smith, W; Weir, MR, 2016
)
0.67
"Because some patients have difficulty swallowing a whole tablet, we investigated the relative bioavailability of a crushed 20 mg rivaroxaban tablet and of 2 alternative crushed tablet dosing strategies."( Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
Damaraju, CV; Fields, LE; Krook, MA; Moore, KT; Sarich, TC; Vaidyanathan, S, 2014
)
2.05
" Then, in 55 healthy adults, relative bioavailability of rivaroxaban administered orally as a whole tablet (Reference [Whole-Oral]), crushed tablet in applesauce suspension (Crushed-Oral), or crushed tablet in water suspension via NG tube (Crushed-NG) were determined."( Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
Damaraju, CV; Fields, LE; Krook, MA; Moore, KT; Sarich, TC; Vaidyanathan, S, 2014
)
2.09
" Relative bioavailability was similar between Crushed-Oral and Reference dosing (Cmax and AUC∞ were within the 80-125% bioequivalence limits)."( Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
Damaraju, CV; Fields, LE; Krook, MA; Moore, KT; Sarich, TC; Vaidyanathan, S, 2014
)
1.85
"A crushed rivaroxaban tablet was stable and when administered orally or via NG tube, displayed similar relative bioavailability compared to a whole tablet administered orally."( Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
Damaraju, CV; Fields, LE; Krook, MA; Moore, KT; Sarich, TC; Vaidyanathan, S, 2014
)
2.25
"The pharmacokinetic model was based on a one-compartment model with an absorption rate described by the sum of three inverse Gaussian densities to reproduce multiphasic and prolonged absorption."( Effect of Activated Charcoal on Rivaroxaban Complex Absorption.
Accassat, S; Basset, T; Bertoletti, L; De Magalhaes, E; Delavenne, X; Escal, J; Hodin, S; Lanoiselée, J; Mismetti, P; Ollier, E, 2017
)
0.74
"Rivaroxaban represents a selective direct inhibitor of activated coagulation factor X (FXa) having peroral bioavailability and prompt onset of action."( Rivaroxaban - Metabolism, Pharmacologic Properties and Drug Interactions.
Briza, J; Brzezkova, R; Kettnerova, K; Kvasnicka, J; Kvasnicka, T; Malikova, I; Netuka, I; Ulrych, J; Zenahlikova, Z; Zima, T, 2017
)
3.34
" Peroral bioavailability is high (80-100 %) and pharmacokinetic variability is considered to be moderate (coefficient of variation 30-40 %)."( Rivaroxaban - Metabolism, Pharmacologic Properties and Drug Interactions.
Briza, J; Brzezkova, R; Kettnerova, K; Kvasnicka, J; Kvasnicka, T; Malikova, I; Netuka, I; Ulrych, J; Zenahlikova, Z; Zima, T, 2017
)
1.9
"Anticoagulation in patients with impaired kidney function can be challenging since drugs' pharmacokinetics and bioavailability are altered in this setting."( Chronic kidney disease and anticoagulation: from vitamin K antagonists and heparins to direct oral anticoagulant agents.
Baldovino, S; Fenoglio, R; Radin, M; Roccatello, D; Schreiber, K; Sciascia, S, 2017
)
0.46
"In this paper, a novel self-nanoemulsifying drug delivery system (SNEDDS) was used to improve the oral bioavailability in fasted state and diminish the food effect for rivaroxaban."( Preparation and Optimization of Rivaroxaban by Self-Nanoemulsifying Drug Delivery System (SNEDDS) for Enhanced Oral Bioavailability and No Food Effect.
Cao, M; Chen, G; Qian, Y; Ren, L; Xue, X, 2018
)
0.96
" Effects of gender, age, and weight on apparent clearance (CL/F) and apparent volume of distribution (V/F), renal function, and comedication on CL/F, and relative bioavailability as a function of dose (F) were analyzed."( Integrated Population Pharmacokinetic Analysis of Rivaroxaban Across Multiple Patient Populations.
Frede, M; Garmann, D; Kubitza, D; Mueck, W; Schmidt, S; Solms, A; Willmann, S; Yan, X; Zhang, L, 2018
)
0.73
" However, due to altered pharmacokinetics and bioavailability of these drugs in CKD, a significant risk of bleeding exists."( [The Multimorbid Patient: Use of New Oral Anticoagulants in Patients with Chronic Kidney Disease].
Mohebbi, N, 2018
)
0.48
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
"The purpose of the currents study was to enhance bioavailability of rivaroxaban (RXB) and reduce the food effect."( Sustained release and enhanced oral bioavailability of rivaroxaban by PLGA nanoparticles with no food effect.
Alalaiwe, A; Aldawsari, MF; Aldayel, AM; Alshahrani, SM; Alzahrani, AA; Ansari, MN; Anwer, MK; Ezzeldin, E; Fatima, F; Iqbal, M; Mohammad, M, 2020
)
1.04
"Rivaroxaban is a new anticoagulant option for dogs, yet its reported oral bioavailability is as low as 60%."( The influence of feeding and gastroprotectant medications on the Factor Xa inhibitory activity of orally administered rivaroxaban in normal dogs.
Brooks, MB; Griffith, E; Hanel, RM; Lynch, AM; Ruterbories, LK; Stablein, AP, 2021
)
2.27
" A PBPK model was developed using mass balance and bioavailability data from adults and qualified using clinically observed data."( Applications of Physiologically Based Pharmacokinetic Modeling of Rivaroxaban-Renal and Hepatic Impairment and Drug-Drug Interaction Potential.
Coboeken, K; Fischer, K; Hügl, B; Kapsa, S; Mück, W; Mundhenke, M; Thelen, K; Willmann, S, 2021
)
0.86
"Direct-acting oral anticoagulants (DOACs) vary in bioavailability and sites of absorption in the gastrointestinal tract (GIT)."( Direct Acting Oral Anticoagulants Following Gastrointestinal Tract Surgery.
Alawaji, Z; Alkhani, M; Alyahya, Z; Hakeam, HA; Ofori, S, 2021
)
0.62
"The objective of the present study was to evaluate the potential of solid dispersion adsorbate (SDA) to improve the solubility and bioavailability of rivaroxaban (RXN)."( Amalgamation of solid dispersion and melt adsorption techniques for augmentation of oral bioavailability of novel anticoagulant rivaroxaban.
Kotta, S; Nair, AB; Patel, MP; Shah, J; Shah, PJ; Vyas, B, 2022
)
1.13
" In-vivo experiments proved that the use of cocrystal instead of form I of free API helped to increase the bioavailability ofrivaroxaban."( Explaining dissolution properties of rivaroxaban cocrystals.
Čerňa, I; Hriňová, E; Kozlík, P; Královičová, J; Křížek, T; Roušarová, J; Ryšánek, P; Šíma, M; Skořepová, E; Slanař, O; Šoóš, M, 2022
)
1.2
" PK study demonstrated a seven times enhanced bioavailability of RXB-SLNs when compared with pure drug."( Rivaroxaban-loaded SLNs with treatment potential of deep vein thrombosis: in-vitro, in-vivo, and toxicity evaluation.
Din, FU; Imran, M; Luo, X; Saleem, A; Sarwar, S; Shafique, U; Ullah, K; Zeb, A, 2023
)
2.35
" This work assessed the impact of liquisolid compact technique in augmenting the solubility and bioavailability of RXN."( Quality-by-Design-Based Development of Rivaroxaban-Loaded Liquisolid Compact Tablets with Improved Biopharmaceutical Attributes.
Desai, H; Kulkarni, M; Lalan, M; Shah, P; Vyas, B, 2023
)
1.18

Dosage Studied

Non-recommended rivaroxaban dosing was associated with less favourable outcomes, possibly due to baseline characteristics. Heparin dosage can be predicted by baseline ACT, but not influenced by duration on or withdrawal of the drug.

ExcerptRelevanceReference
" Dosing regimens were 5 mg once, twice (bid), or three times daily, and 10 mg, 20 mg, or 30 mg bid."( Safety, pharmacodynamics, and pharmacokinetics of BAY 59-7939--an oral, direct Factor Xa inhibitor--after multiple dosing in healthy male subjects.
Becka, M; Kubitza, D; Voith, B; Wensing, G; Zuehlsdorf, M, 2005
)
0.33
" The primary efficacy analysis did not demonstrate any significant trend in dose-response relationship for BAY 59-7939."( Oral, direct Factor Xa inhibition with BAY 59-7939 for the prevention of venous thromboembolism after total hip replacement.
Borris, L; Dahl, OE; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F, 2006
)
0.33
" No significant dose-response relationship was found for efficacy (P=0."( A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement.
Borris, LC; Dahl, OE; Dierig, C; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F; Muehlhofer, E, 2006
)
0.59
"Rivaroxaban showed efficacy and safety similar to enoxaparin for thromboprophylaxis after total hip replacement, with the convenience of once-daily oral dosing and without the need for coagulation monitoring."( A once-daily, oral, direct Factor Xa inhibitor, rivaroxaban (BAY 59-7939), for thromboprophylaxis after total hip replacement.
Borris, LC; Dahl, OE; Dierig, C; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F; Muehlhofer, E, 2006
)
2.03
" The dose-response relationship with rivaroxaban for the primary efficacy endpoint was not statistically significant (p=0."( Dose-escalation study of rivaroxaban (BAY 59-7939)--an oral, direct Factor Xa inhibitor--for the prevention of venous thromboembolism in patients undergoing total hip replacement.
Borris, LC; Dahl, OE; Eriksson, BI; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Misselwitz, F; Muehlhofer, E, 2007
)
0.92
" There was no significant trend in the dose-response relationship between rivaroxaban BID and the primary efficacy end point (P=0."( Treatment of proximal deep-vein thrombosis with the oral direct factor Xa inhibitor rivaroxaban (BAY 59-7939): the ODIXa-DVT (Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients With Acute Symptomatic Deep-Vein Thrombosis) study.
Agnelli, G; Gallus, A; Goldhaber, SZ; Haas, S; Huisman, MV; Hull, RD; Kakkar, AK; Misselwitz, F; Schellong, S, 2007
)
0.8
" However, the effects of covariates on the pharmacokinetics of rivaroxaban were generally small, and predictions of 'extreme' case scenarios suggested that fixed dosing of rivaroxaban was likely to be possible."( Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery.
Bauer, KA; Borris, L; Dahl, OE; Eriksson, BI; Fisher, WD; Gent, M; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Kwong, LM; Misselwitz, F; Mueck, W; Turpie, AG, 2008
)
0.84
" The findings suggested that fixed dosing of rivaroxaban may be possible in patients undergoing major orthopaedic surgery."( Population pharmacokinetics and pharmacodynamics of rivaroxaban--an oral, direct factor Xa inhibitor--in patients undergoing major orthopaedic surgery.
Bauer, KA; Borris, L; Dahl, OE; Eriksson, BI; Fisher, WD; Gent, M; Haas, S; Huisman, MV; Kakkar, AK; Kälebo, P; Kwong, LM; Misselwitz, F; Mueck, W; Turpie, AG, 2008
)
0.86
"Rivaroxaban was absorbed rapidly, reaching peak plasma concentration (C(max)) 4 h after dosing in all groups."( Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects.
Becka, M; Kubitza, D; Mueck, W; Roth, A, 2008
)
2.02
" Adverse events were somewhat elevated in the 50 mg group, but given the small sample size, no specific conclusions can be drawn about this dosing level."( Dose-escalation study of the pharmacokinetics and pharmacodynamics of rivaroxaban in healthy elderly subjects.
Becka, M; Kubitza, D; Mueck, W; Roth, A, 2008
)
0.58
" The use of algorithms for dosing that incorporate pharmacogenomic information perform better than those using clinical data alone."( New issues in oral anticoagulants.
Francis, CW, 2008
)
0.35
" Its consistent and predictable pharmacokinetics and pharmacodynamics across a wide range of patient populations allow administration with fixed dosing and with no coagulation monitoring."( [Rivaroxaban (Xarelto): efficacy and safety].
Arnaout, L; Bellamy, L; Chabbouh, T; Rosencher, N, 2008
)
1.26
" There is a clinical need for novel anticoagulants offering improvements over current standard of care, such as fixed oral dosing and no need for routine monitoring."( Rivaroxaban -- an oral, direct Factor Xa inhibitor: lessons from a broad clinical study programme.
Haas, S, 2009
)
1.8
" It has the major advantages of once daily oral dosing and no required laboratory monitoring, giving it the potential to replace current antithrombotics in the market today."( Rivaroxaban: an oral direct factor Xa inhibitor for the prevention of thromboembolism.
Chen, T; Lam, S,
)
1.57
" In this setting, we assessed the safety and efficacy of rivaroxaban and aimed to select the most favourable dose and dosing regimen."( Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial.
Barnathan, ES; Bordes, P; Braunwald, E; Burton, P; Gibson, CM; Hricak, V; Markov, V; Mega, JL; Misselwitz, F; Mohanavelu, S; Oppenheimer, L; Poulter, R; Witkowski, A, 2009
)
2.04
" Despite the comprehensive and extensive nature of this program, it had some logistic issues that included the dosing of the enoxaparin which was not only inconsistent with the recommendations but the dosages used were not optimal."( Interpretation of benefit-risk of enoxaparin as comparator in the RECORD program: rivaroxaban oral tablets (10 milligrams) for use in prophylaxis in deep vein thrombosis and pulmonary embolism in patients undergoing hip or knee replacement surgery.
Haque, W; Kalodiki, E; Litinas, E; Rao, G; Van Thiel, D; Wahi, R,
)
0.36
" The advantages of LMWH are the better dose-response relationship and reduced need for monitoring."( [Patients with oral anticoagulation--bridging anticoagulation in the perioperative phase].
Koscielny, J; von Heymann, C; Ziemer, S, 2009
)
0.35
" Maximal inhibition of FXa activity was achieved within 1-3 h of dosing in the single-dose study [at 20 mg FXa inhibition as a median percentage change from baseline, 45."( Safety, pharmacokinetics and pharmacodynamics of single/multiple doses of the oral, direct Factor Xa inhibitor rivaroxaban in healthy Chinese subjects.
Bauer, RJ; Cui, Y; Kubitza, D; Liu, Y; Mueck, W; Sun, P; Zhang, H; Zhao, X; Zhou, Y, 2009
)
0.56
" Dabigatran is mainly eliminated by renal excretion (a fact which affects the dosage in elderly and in moderate-severe renal failure patients), and no hepatic metabolism by cytochrome P450 isoenzymes has been observed, showing a good interaction profile."( [Pharmacokinetics and pharmacodynamics of the new oral anticoagulants dabigatran and rivaroxaban].
Climent Grana, E; Jover Botella, A; Ordovás Baines, JP; Valero García, I,
)
0.36
" These drugs have predictable pharmacokinetics that allow fixed dosing without laboratory monitoring, and are being compared with vitamin K antagonists or aspirin in phase III clinical trials [corrected]."( New anticoagulants for atrial fibrillation.
Eikelboom, J; O'Donnell, M; Sobieraj-Teague, M, 2009
)
0.35
" Maximal inhibition of FXa occurred 2-3hours after dosing and returned to baseline after 24-48hours, reflecting rivaroxaban plasma concentrations."( Safety, pharmacokinetics and pharmacodynamics of single doses of rivaroxaban - an oral, direct factor Xa inhibitor - in elderly Chinese subjects.
Bauer, RJ; Hu, P; Hu, Y; Jiang, J; Kubitza, D; Meng, L; Mueck, W; Yang, J; Zhang, J, 2010
)
0.81
" Depending on its dosage its effectiveness in comparison with vitamin K antagonists is equal or even better without disadvantages in safety."( [New oral anticoagulants: better than vitamin K antagonists?].
Alban, S; Völler, H; Westermann, D, 2010
)
0.36
" Efficacy and safety of oral anticoagulation is limited by a narrow therapeutical range as well as by inter- and intraindividual variability of INR-values due to genetic disposition, differences in alimentation, dosage errors, rare control of INR-levels and drug-interactions."( [Novel anticoagulants for stroke prevention in atrial fibrillation].
Baumhäkel, M; Böhm, M; Schirmer, SH, 2010
)
0.36
" These compounds present a convenient route of administration with predictable pharmacokinetics and pharmacodynamics that allow fixed dosing regimens without requiring coagulation monitoring."( Investigational factor Xa inhibitors for thrombosis and acute coronary syndromes.
Ageno, W; Romualdi, E, 2011
)
0.37
" The predicted dosing window is highly accordant with the final dose recommendation based upon extensive clinical studies."( Evaluation of the efficacy and safety of rivaroxaban using a computer model for blood coagulation.
Burghaus, R; Coboeken, K; Gaub, T; Kuepfer, L; Lippert, J; Mueck, W; Sensse, A; Siegmund, HU; Weiss, W, 2011
)
0.64
" Additional concerns refer to the dosing-regimens and their practical administration: Fondaparinux, rivaroxaban and dabigatran are dosed to achieve maximum effects very close to their limits of tolerance whereas wide dosing spectra for the low molecular weight herparin (LMWH)'s indicate the potential for dose adaptation and increase."( Prophylaxis of venous thromboembolism: low molecular weight heparin compared to the selective anticoagulants rivaroxaban, dabigatran and fondaparinux.
Fareed, J; Hull, R; Welzel, D, 2011
)
0.8
" Effects of heparin in neonatal plasma differ from those in adult plasma, and dosage recommendations cannot be extrapolated from adult trials."( Effect of rivaroxaban, in contrast to heparin, is similar in neonatal and adult plasma.
Bernhard, H; Leschnik, B; Muntean, W; Novak, M; Schlagenhauf, A; Schweintzger, S, 2011
)
0.77
"Over recent years, research on anticoagulant drugs has been guided by the requirement for convenient administration and a wide therapeutic window to allow fixed dosing without the need for coagulation monitoring."( Oral rivaroxaban after symptomatic venous thromboembolism: the continued treatment study (EINSTEIN-extension study).
Ageno, W; Donadini, MP; Romualdi, E, 2011
)
0.88
" Clinicians are increasingly being challenged with making uncertain anticoagulant dosing decisions, as the optimal dosing strategy for most anticoagulants in the obese patient population remains unknown."( Anticoagulating obese patients in the modern era.
Arya, R; Patel, JP; Roberts, LN, 2011
)
0.37
" These favourable pharmacological properties underpin the use of rivaroxaban in fixed dosing regimens, with no need for dose adjustment or routine coagulation monitoring."( Pharmacodynamic and pharmacokinetic basics of rivaroxaban.
Kreutz, R, 2012
)
0.88
" There was no evidence of heterogeneity in treatment effect across dosing groups."( Prevention of stroke and systemic embolism with rivaroxaban compared with warfarin in patients with non-valvular atrial fibrillation and moderate renal impairment.
Becker, RC; Califf, RM; Fox, KA; Halperin, JL; Hankey, GJ; Mahaffey, KW; Nessel, CC; Paolini, JF; Patel, MR; Piccini, JP; Singer, DE; Wojdyla, D, 2011
)
0.62
" Rivaroxaban was also effective following oral dosing at 3 mg/kg."( Arterial antithrombotic activity of rivaroxaban, an orally active factor Xa inhibitor, in a rat electrolytic carotid artery injury model of thrombosis.
Andrade-Gordon, P; Chen, C; Connelly, MA; Damiano, BP; Huang, Z; Parry, TJ; Perzborn, E, 2011
)
1.55
" In addition, we must be aware to have a deliberate evaluation for each result, even pharmacological profiles of each Xa inhibitors with a 12 hour half-life period shows similarity, the difference in twice-daily dosing with once a day, or the difference in severity of patients' atrial fibrillation risk factor each trial contains might affect the results of phase III trials."( [Current status and future of anti-Xa inhibitors].
Nagao, T, 2011
)
0.37
" The emergence of new anticoagulants that offer equal or superior efficacy, greater safety and the convenience of fixed oral dosing may make warfarin the less preferred option."( Prevention of stroke in patients with atrial fibrillation: anticoagulant and antiplatelet options.
Halperin, JL; Varughese, CJ, 2012
)
0.38
" The clinical pharmacology of rivaroxaban supports a convenient, oral, once-daily dosing regimen without the need for routine coagulation monitoring after THA or TKA."( Rivaroxaban, an oral, direct factor Xa inhibitor: a new option for thromboprophylaxis.
Kwong, LM, 2012
)
2.11
" These agents promise to be more convenient to administer with fixed dosing but still have equivalent efficacy and improved bleeding risk compared to warfarin."( Newer oral anticoagulant agents: a new era in medicine.
Goel, R; Srivathsan, K, 2012
)
0.38
" It is suggested to perform EXCA tests for each individual patient to determine the real drug dosage he needs to reach 10-20% of normal EXCA for therapy or 20-40% of normal EXCA for prophylaxis."( Determination of the anti-F10a or anti-F2a generation action of rivaroxaban or dabigatran.
Stief, TW, 2012
)
0.62
" The requirement for a twice-daily dosage regimen, the lack of an anticoagulation monitoring option, the relatively short duration of action and the lack of an antidote may even prove to be crucial disadvantages in clinical practice in comparison to vitamin K antagonists."( [New oral anticoagulants for the prevention of stroke. Open questions in geriatric patients].
Berthold, HK, 2012
)
0.38
" They have a slow onset and offset of action, narrow therapeutic window, marked dose-response variability, and multiple food and drug interactions, and require frequent coagulation monitoring and dose adjustments."( Emerging anticoagulant therapies for atrial fibrillation: new options, new challenges.
Mangiafico, M; Mangiafico, RA, 2012
)
0.38
" Patients who met at least one caution or contraindication criteria were deemed "non-candidates"; potential dosage reductions of the new oral anticoagulants were not considered."( Analysis of the projected utility of dabigatran, rivaroxaban, and apixaban and their future impact on existing Hematology and Cardiology Anticoagulation Clinics at The Johns Hopkins Hospital.
Carter, KL; Kraus, PS; Ross, PA; Shermock, KM; Streiff, MB; Thomas, ML; Wellman, JC, 2012
)
0.63
"Current anticoagulation therapy in children is less than ideal, requiring regular venous monitoring and dosing adjustments."( The in vitro anticoagulant effect of rivaroxaban in children.
Attard, C; Ignjatovic, V; Kubitza, D; Monagle, P, 2012
)
0.65
"In vivo studies are required to confirm the consistency of dose-response across the paediatric age groups."( The in vitro anticoagulant effect of rivaroxaban in children.
Attard, C; Ignjatovic, V; Kubitza, D; Monagle, P, 2012
)
0.65
" Based on the RE-LY and ROCKET AF trial results, we investigated the cost-effectiveness of dabigatran (twice daily dosing of 150 mg or 110 mg based on patient age) versus rivaroxaban from a Canadian payer perspective."( Dabigatran versus rivaroxaban for the prevention of stroke and systemic embolism in atrial fibrillation in Canada. Comparative efficacy and cost-effectiveness.
Bradley-Kennedy, C; Clemens, A; Kansal, AR; Monz, BU; Peng, S; Roskell, N; Sharma, M; Sorensen, SV, 2012
)
0.91
" These newer agents possess a highly predictable pharmacokinetic-pharmacodynamic relationship, allowing for fixed dosing and no necessity for routine laboratory monitoring; additionally these agents have minimal drug interactions."( New anticoagulants for stroke prophylaxis in atrial fibrillation: assessing the impact on medication adherence.
Kopecky, S, 2012
)
0.38
" Linearity of dose-response and responsiveness to increasing dose in addition to standardization are other important issues to consider."( Laboratory tests and the new oral anticoagulants.
Tripodi, A, 2012
)
0.38
" These results, in conjunction with its convenient once-daily dosing regimen, make rivaroxaban an attractive alternative to warfarin for stroke prevention in AF."( Rivaroxaban for stroke prevention in atrial fibrillation: a critical review of the ROCKET AF trial.
Eikelboom, JW; Manolakos, JJ; Paikin, JS, 2012
)
2.05
" The first, monitoring, implies laboratory testing to assess the drug's effect and to adjust the dosage to maintain anticoagulation within the therapeutic interval."( The laboratory and the new oral anticoagulants.
Tripodi, A, 2013
)
0.39
" The choice of tests is based on such characteristics as availability, linearity of the dose-response curve, standardization, and responsiveness to increasing drug dosage."( The laboratory and the new oral anticoagulants.
Tripodi, A, 2013
)
0.39
"Low intra-, but high inter-individual imprecision was found for PT displaying a linear dose-response relationship."( Measuring Rivaroxaban in a clinical laboratory setting, using common coagulation assays, Xa inhibition and thrombin generation.
Dinkelaar, J; Leyte, A; Molenaar, PJ, 2012
)
0.78
" Selected compounds were dosed orally in rats and checked for their ex vivo prothrombin time prolonging activity, which resulted in identification of compound 5-chloro-N-(5-chloropyridin-2-yl)-2-(4-(N-(2-(diethylamino)acetyl)-S-methylsulfonimidoyl)benzamido)benzamide (18f)."( Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
Ajani, H; Chakrabarti, G; Chaugule, B; Jain, M; Jarag, T; Joshi, J; Joshi, N; Kumar, J; Pandya, V; Parmar, B; Patel, H; Patel, J; Patel, P; Rath, A; Sairam, KV; Sharma, B; Soni, H; Unadkat, V, 2012
)
0.38
" However, in these trials patients with morbid obesity were not reported and it is unknown if the standard dosage of 20 mg rivaroxaban is sufficient for bariatric patients, especially after bariatric surgery, which may impact the resorption of rivaroxaban."( Pharmacokinetics of rivaroxaban after bariatric surgery: a case report.
Beyer-Westendorf, J; Gehrisch, S; Mahlmann, A, 2013
)
0.92
" Rivaroxaban, apixaban, and dabigatran have different pharmacological characteristics, and guidance is needed on optimum doses and dosing intervals and the effects of renal or hepatic impairment, age, food, and other drugs."( Novel oral anticoagulants: clinical pharmacology, indications and practical considerations.
Graff, J; Harder, S, 2013
)
1.3
" Consequently, if renal function is impaired, there is a risk of drug accumulation that is highest for dabigatran followed by rivaroxaban and then apixaban and thus dosing recommendations are different."( Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban.
Böhm, M; Dichgans, M; Diener, HC; Ell, C; Endres, M; Epple, C; Grond, M; Laufs, U; Nickenig, G; Riess, H; Röther, J; Schellinger, PD; Spannagl, M; Steiner, T; Veltkamp, R, 2013
)
0.8
" Patients with moderate renal impairment receiving the reduced rivaroxaban dosage (15 mg once daily) showed a treatment effect consistent with that seen with rivaroxaban 20 mg once daily in patients with normal renal function."( Rivaroxaban: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation.
Carter, NJ; Plosker, GL, 2013
)
2.07
"The dosing of anticoagulants is critical when balancing efficacy and safety."( Comparison of the efficacy and safety of two rivaroxaban doses in acute coronary syndrome (from ATLAS ACS 2-TIMI 51).
Braunwald, E; Gibson, CM; Gotcheva, N; Mega, JL; Murphy, SA; Plotnikov, A; Ruda, M; Wiviott, SD, 2013
)
0.65
" If transition from rivaroxaban to vitamin K antagonist is needed, timely monitoring and careful dosing should be used to ensure consistent and adequate anticoagulation."( End of study transition from study drug to open-label vitamin K antagonist therapy: the ROCKET AF experience.
Becker, RC; Berkowitz, SD; Breithardt, G; Califf, RM; Fox, KA; Hacke, W; Halperin, JL; Hankey, GJ; Hannan, KL; Hellkamp, AS; Mahaffey, KW; Nessel, CC; Patel, MR; Piccini, JP; Schwabe, K; Singer, DE, 2013
)
0.71
" In this review, we outline key pharmacokinetic and pharmacodynamic features of each compound and provide guidance on selection and dosing of the 3 NOACs relative to warfarin when considering OAC therapy for AF patients."( Importance of pharmacokinetic profile and variability as determinants of dose and response to dabigatran, rivaroxaban, and apixaban.
Gong, IY; Kim, RB, 2013
)
0.6
" If the anticoagulant dosage is not immediately available, worse propositions, based on the usual tests (prothrombin time and activated partial thromboplastin time), are presented."( Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013.
Albaladejo, P; Blais, N; Cohen, A; de Maistre, E; Fontana, P; Godier, A; Gruel, Y; Llau, JV; Mismetti, P; Pernod, G; Rosencher, N; Samama, CM; Samama, MM; Schved, JF; Sié, P; Susen, S,
)
0.13
" However the choice of dosing regimens in different clinical conditions has been different for the various NOACs, and has been established on the basis of widely different considerations, including the clinical setting (venous versus arterial thrombosis), the indications (prophylaxis versus treatment), the likelihood of concomitant antiplatelet drugs, and marketing opportunities; these latter were based on the knowledge that patients' compliance is generally better with once daily than with twice daily dosing."( The new oral anticoagulants in atrial fibrillation: once daily or twice daily?
De Caterina, R; Renda, G,
)
0.13
"The objective of this study was to develop and qualify a physiologically based pharmacokinetic (PBPK) model for rivaroxaban doses of 10 and 20 mg in adults and to scale this model to the paediatric population (0-18 years) to inform the dosing regimen for a clinical study of rivaroxaban in paediatric patients."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.84
" The pharmacokinetic properties of rivaroxaban in virtual populations of children were simulated for two body weight-related dosing regimens equivalent to 10 and 20 mg once daily in adults."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.91
"Simulations for AUC, C max and C 24h throughout the investigated age range largely overlapped with values obtained for the corresponding dose in the adult reference simulation for both body weight-related dosing regimens."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.63
"The paediatric PBPK model developed here allowed an exploratory analysis of the pharmacokinetics of rivaroxaban in children to inform the dosing regimen for a clinical study in paediatric patients."( Development of a paediatric population-based model of the pharmacokinetics of rivaroxaban.
Becker, C; Burghaus, R; Coboeken, K; Edginton, A; Lippert, J; Mück, W; Siegmund, HU; Thelen, K; Willmann, S, 2014
)
0.85
" These new anticoagulants do not require strict and frequent laboratory monitoring, dosing adjustments, or dietary restrictions, and they incur fewer drug-drug interactions than warfarin."( Novel oral anticoagulants: a review of new agents.
Wanat, MA, 2013
)
0.39
" If the dosage of the drug is not immediately available, proposals only based on the usual tests, PT and aPTT, also are presented."( [Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors. Proposals of the Working Group on Perioperative Haemostasis (GIHP) - March 2013].
Albaladejo, P; Blais, N; Cohen, A; de Maistre, E; Fontana, P; Godier, A; Gruel, Y; Llau, JV; Mismetti, P; Pernod, G; Rosencher, N; Samama, CM; Samama, MM; Schved, JF; Sié, P; Susen, S, 2013
)
0.39
" The authors recommend caution while dosing dabigatran in the Asian population, as the estimates of kidney functioning vary substantially depending on the formula used to estimate GFR, which may in turn lead in some cases of inadequate dosing of dabigatran."( A comparison of methods for estimating glomerular filtration rate for a population in Hawai'i with non-valvular atrial fibrillation.
Azuma, S; Lum, CJ, 2013
)
0.39
"Pharmacogenetics-guided warfarin dosing is an alternative to standard clinical algorithms and new oral anticoagulants for patients with nonvalvular atrial fibrillation."( Cost-effectiveness of pharmacogenetics-guided warfarin therapy vs. alternative anticoagulation in atrial fibrillation.
Hughes, DA; Lane, S; Pink, J; Pirmohamed, M, 2014
)
0.4
" Advantages and disadvantages to using these newer agents are presented, as are dosing adjustments for renal and hepatic impairment."( Outpatient management of oral anticoagulation in atrial fibrillation.
Manning, JA, 2013
)
0.39
" However, although rivaroxaban is used as a twice-daily regimen for the initial treatment of venous thromboembolism (VTE) and secondary prevention after acute coronary syndromes, the approved dosing is once-daily for prevention of VTE after orthopaedic surgery, long-term secondary prevention of VTE and stroke prevention in patients with non-valvular atrial fibrillation."( A clinical and pharmacologic assessment of once-daily versus twice-daily dosing for rivaroxaban.
Kreutz, R, 2014
)
0.96
" These drugs differ in a several important respects from warfarin; most notably they have a reliable dose-response effect which means they can be given without the need for monitoring."( New oral anticoagulants: their role and future.
Laffan, M; Shapiro, S, 2013
)
0.39
" Its predictable pharmacokinetic profile, high oral bioavailability and once-daily dosing make rivaroxaban an optimal anticoagulant that warrants investigation in neonates."( The in-vitro anticoagulant effect of rivaroxaban in neonates.
Attard, C; Ignjatovic, V; Kubitza, D; Monagle, P, 2014
)
0.89
"The use of rivaroxaban in fixed dosing regimens without need for routine coagulation monitoring may lead to the misconception that there is a minimal risk of drug-drug interactions."( Gastrointestinal bleeding associated with rivaroxaban administration in a treated patient infected with human immunodeficiency virus.
Battegay, M; Elzi, L; Lakatos, B; Marzolini, C; Stoeckle, M, 2014
)
1.06
" In contrast to warfarin, most NOACs need dosage adjustments in renal impairment and are contraindicated in severe liver impairment, and there are no specific antidotes for treating NOAC-related over-anticoagulation."( New oral anticoagulants in practice: pharmacological and practical considerations.
Bajorek, B; Wang, Y, 2014
)
0.4
" They are at least as effective and as safe as conventional therapy (heparins and vitamin-K inhibitors) and have practical advantages, such as fixed dosing and no need for laboratory monitoring."( Direct oral anticoagulants in the treatment and long-term prevention of venous thrombo-embolism.
Bounameaux, H; Fontana, P; Goldhaber, SZ, 2014
)
0.4
"Two once-daily rivaroxaban dosing regimens were compared with warfarin for stroke prevention in patients with non-valvular atrial fibrillation in ROCKET AF: 20 mg for patients with normal/mildly impaired renal function and 15 mg for patients with moderate renal impairment."( Population pharmacokinetics and pharmacodynamics of rivaroxaban in patients with non-valvular atrial fibrillation: results from ROCKET AF.
Becker, RC; Califf, RM; Fox, KA; Girgis, IG; Halperin, JL; Mahaffey, KW; Moore, KT; Nessel, CC; Patel, MR; Peters, GR, 2014
)
1.01
" In the studied dosing regimens, these drugs failed to show a net clinical benefit in addition to dual antiplatelet therapy."( Direct oral anticoagulants in acute coronary syndrome.
Ahrens, I; Bode, C, 2014
)
0.4
" Chromogenic anti-FXa assays showed linear dose-response curves with apixaban."( Effects of the oral, direct factor Xa inhibitor apixaban on routine coagulation assays and anti-FXa assays.
Baghaei, F; Berndtsson, M; Fagerberg Blixter, I; Faxälv, L; Gustafsson, KM; Hillarp, A; Lindahl, TL; Strandberg, K, 2014
)
0.4
" The most frequent inappropriate criteria were inappropriate choice (28% of patients), wrong dosage (26%), and impractical modalities of administration (26%)."( Appropriateness of prescribing dabigatran etexilate and rivaroxaban in patients with nonvalvular atrial fibrillation: a prospective study.
Chatelain, C; Devalet, B; Dogné, JM; Douxfils, J; Larock, AS; Mullier, F; Sennesael, AL; Spinewine, A, 2014
)
0.65
"Compared to Vitamin K antagonists (VKA), novel oral anticoagulants (NOACs) appear to be safer in terms of major bleeding risks with added advantage of having fixed dosing schedules when used in patients with non-valvular atrial fibrillation (AF)."( Evaluation of Trends of Inpatient Hospitalisation for Significant Haemorrhage in Patients Anticoagulated for Atrial Fibrillation before and after the Release of Novel Anticoagulants.
Aryal, MR; Badal, M; Chaudhary, A; Donato, AA; Mege, J, 2015
)
0.42
" The dosing of rivaroxaban varies and adheres to specific schedules in each of the clinical settings in which it has been investigated."( Clinical use of rivaroxaban: pharmacokinetic and pharmacodynamic rationale for dosing regimens in different indications.
Dobesh, PP; Trujillo, T, 2014
)
1.1
" Coagulation biomarkers in shed blood were assessed at 3 h after monotherapy with the medicines under study, at 3 h after triple therapy dosing and at steady state trough conditions."( Antithrombotic triple therapy and coagulation activation at the site of thrombus formation: a randomized trial in healthy subjects.
Eichinger, S; Gouya, G; Kapiotis, S; Kyrle, PA; Litschauer, B; Mayer, P; Smerda, L; Weisshaar, S; Wolzt, M, 2014
)
0.4
" Practical advantages of NOACs over warfarin include fixed once- or twice-daily oral dosing without the need for coagulation monitoring, and few known or defined drug or food interactions."( Approach to the new oral anticoagulants in family practice: part 1: comparing the options.
Bell, AD; Douketis, J; Eikelboom, J; Liew, A, 2014
)
0.4
" This study examines the relative cost-effectiveness of dabigatran (BID dosing of 150 mg or 110 mg based on patient age), rivaroxaban, and apixaban from a UK payer perspective."( Comparison of the cost-effectiveness of new oral anticoagulants for the prevention of stroke and systemic embolism in atrial fibrillation in a UK setting.
Gonschior, AK; Heinrich-Nols, J; Kansal, AR; Noack, H; Sorensen, SV; Sunderland, T; Zheng, Y, 2014
)
0.61
"New oral anticoagulants require dosing adjustment according to renal function."( Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation.
Andreu-Cayuelas, JM; Gallego, P; Lip, GY; Manzano-Fernández, S; Marín, F; Orenes-Piñero, E; Roldán, V; Valdés, M; Vicente, V, 2015
)
0.42
"Among the overall population, relative to Cockcroft-Gault, discordance in dabigatran dosage was 11."( Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation.
Andreu-Cayuelas, JM; Gallego, P; Lip, GY; Manzano-Fernández, S; Marín, F; Orenes-Piñero, E; Roldán, V; Valdés, M; Vicente, V, 2015
)
0.42
" The RapidTEG activated clotting time test allowed the creation of a dose-response curve for all 3 NOACs."( Use of Thromboelastography (TEG) for Detection of New Oral Anticoagulants.
Dias, JD; Doorneweerd, DD; Norem, K; Omert, LA; Popovsky, MA; Thurer, RL, 2015
)
0.42
" The primary outcome included appropriateness of the first day of therapy based on indication and renal function per FDA-approved dosing recommendations for the prevention of stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) and for the treatment or prevention of venous thromboembolism (VTE)."( Evaluation of the appropriateness of dosing, indication and safety of rivaroxaban in a community hospital.
Armbruster, AL; Daly, MW; Patel, S; Tellor, KB, 2015
)
0.65
" Because of renal failure with a creatinine clearance of 32ml/min, a dosage of rivaroxaban 10mg/d was chosen."( Rivaroxaban 10mg/d in severe renal failure does not prevent ischemic events in premorbid neurologic disease.
Finsterer, J; Stöllberger, C, 2015
)
2.09
" The dosing regimens of rivaroxaban vary depending on the indication, and phase III studies have demonstrated a favourable benefit-risk profile of rivaroxaban compared with traditional standard of care."( Rivaroxaban for the treatment and prevention of thromboembolic disease.
Antoniou, S, 2015
)
2.17
" Once-daily dosing and the lack of coagulation monitoring may increase utilization and adherence compared with warfarin, potentially decreasing the large burden of care associated with stroke secondary to AF."( Rivaroxaban in the Prevention of Stroke and Systemic Embolism in Patients with Non-Valvular Atrial Fibrillation: Clinical Implications of the ROCKET AF Trial and Its Subanalyses.
Amerena, JV; Spencer, RJ, 2015
)
1.86
"To review current literature for target-specific oral anticoagulants (TSOACs) and provide critical analysis for dosing recommendations in special population groups."( Dosing of Target-Specific Oral Anticoagulants in Special Populations.
Ge, D; Morrill, AM; Willett, KC, 2015
)
0.42
" It is valuable to understand the rationale for labeled dosing recommendations in nonvalvular atrial fibrillation and venous thromboembolism treatment and prevention, particularly in patients that fall into special population groups."( Dosing of Target-Specific Oral Anticoagulants in Special Populations.
Ge, D; Morrill, AM; Willett, KC, 2015
)
0.42
" In this regard, novel oral anticoagulants (NOACs) have shown promise in the shift toward the "ideal" anticoagulant therapy, in that fixed dosing is the norm, drug interactions are few, food interactions are absent, onset is fairly immediate and offset predictable, and, in the majority of patients, therapeutic monitoring is not required."( Novel Anticoagulants in Atrial Fibrillation: A Primer for the Primary Physician.
Mookadam, F; Mookadam, M; Shamoun, FE,
)
0.13
"Once daily dosing schedule is associated with increased adherence to and persistence with cardiovascular therapies."( Adherence to and persistence with non-vitamin K-antagonist oral anticoagulants: does the number of pills per day matter?
Rubboli, A, 2015
)
0.42
"This review will provide a brief overview of the cell-based coagulation model, the main determinants of arterial and venous thrombosis, and the pharmacological rationale and clinical evidence for the different dosing regimens of rivaroxaban."( Dosing of rivaroxaban by indication: getting the right dose for the patient.
Arellano-Rodrigo, E; Carne, X; Escolar, G, 2015
)
1
" In this study, neither PT, APTT, nor RX concentration returned to the values measured prior to dosing even at 24 hours after administration of RX."( [Changes in PT and APTT When Administrating Rivaroxaban, a Direct Inhibitor of Activated Factor X].
Furukawa, T; Kawasugi, K; Matsuzawa, M; Miyazawa, Y; Nogi, K; Okufuji, Y; Shimadu, C, 2015
)
0.68
" The increasing dosage was driven by the need to avoid recurrence of skin necrosis."( Thrombin generation and other coagulation parameters in a patient with homozygous congenital protein S deficiency on treatment with rivaroxaban.
Artoni, A; Chantarangkul, V; Clerici, M; Martinelli, I; Passamonti, S; Peyvandi, F; Tripodi, A, 2016
)
0.64
" To our knowledge, no data are presently available to guide DOAC dosing in the postpartum period when pharmacokinetic and pharmacodynamic changes induced by pregnancy have an impact on drug clearance and increase hypercoagulability for a period of 6-8 weeks after delivery."( Possible Rivaroxaban Failure during the Postpartum Period.
Panneerselvam, N; Rudd, KM; Winans, AR, 2015
)
0.83
" The aim of the present study was to evaluate the hypothetical need for dosage adjustment (based on fluctuations in kidney function) of dabigatran, rivaroxaban and apixaban during the first 6 months after hospital discharge in patients with concomitant atrial fibrillation and heart failure."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.63
" The hypothetical recommended dosage of dabigatran, rivaroxaban and apixaban according to renal function was determined at discharge."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.68
"Among the overall study population, 44% of patients would have needed dabigatran dosage adjustment during follow-up, 35% would have needed rivaroxaban adjustment, and 29% would have needed apixaban dosage adjustment."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.64
"The need for dosage adjustment of nonvitamin K oral anticoagulants during follow-up is frequent in patients with atrial fibrillation after acute decompensated heart failure, especially among older patients and those with renal impairment."( Impact of Variations in Kidney Function on Nonvitamin K Oral Anticoagulant Dosing in Patients With Atrial Fibrillation and Recent Acute Heart Failure.
Andreu-Cayuelas, JM; Flores-Blanco, PJ; García-Alberola, A; Lip, GY; Manzano-Fernández, S; Mateo-Martínez, A; Pastor-Pérez, FJ; Puche, CM; Roldán, V; Valdés, M, 2016
)
0.43
" However, the short half-life of NOAC means that twice-a-day dosing is needed and there is higher risk of a prothrombotic state when doses are missed."( Novel oral anticoagulants for atrial fibrillation.
How, CH, 2015
)
0.42
" The mean anti-FXa values were significantly lower in patients before rivaroxaban dosing than after."( Effects of Rivaroxaban Therapy on ROTEM Coagulation Parameters in Patients with Venous Thromboembolism.
Chojnowski, K; Górski, T; Robak, M; Treliński, J,
)
0.76
" We also aimed to propose expected steady state peak and trough antifactor Xa activities for these agents based upon dosing regimens approved for nonvalvular atrial fibrillation."( Evaluation of a Heparin-Calibrated Antifactor Xa Assay for Measuring the Anticoagulant Effect of Oral Direct Xa Inhibitors.
Beyer, J; Fisher, S; Kiser, TH; Ko, A; Lind, SE; Trujillo, T, 2016
)
0.43
"Although initially investigated for twice-daily dosing, early observations, including the finding that the pharmacodynamic effects of rivaroxaban last longer than the elimination half-life, suggested that once-daily dosing might be attainable and effective."( Evidence-Based Development and Rationale for Once-Daily Rivaroxaban Dosing Regimens Across Multiple Indications.
Berkowitz, SD; Kubitza, D; Misselwitz, F, 2016
)
0.88
"The evidence for each dosing regimen demonstrates that although pharmacology studies are of paramount importance, dose regimens must be subjected to careful empirical validation."( Evidence-Based Development and Rationale for Once-Daily Rivaroxaban Dosing Regimens Across Multiple Indications.
Berkowitz, SD; Kubitza, D; Misselwitz, F, 2016
)
0.68
"RELAXED (Recurrent Embolism Lessened by rivaroxaban, an Anti-Xa agent, of Early Dosing for acute ischemic stroke and transient ischemic attack with atrial fibrillation) study is an observational study designed to investigate the optimal timing to start administration of rivaroxaban for prevention of recurrence in NVAF patients in the acute phase of cardioembolic stroke (ClinicalTrials."( Design and Rationale of the RELAXED (Recurrent Embolism Lessened by rivaroxaban, an Anti-Xa agent, of Early Dosing for acute ischemic stroke and transient ischemic attack with atrial fibrillation) Study.
Hamasaki, T; Hirano, T; Minematsu, K; Mori, E; Nagao, T; Toyoda, K; Yamagami, H; Yamaguchi, T; Yasaka, M; Yoshimura, S, 2016
)
0.94
" Further research is needed to better understand appropriate dosing of patients with novel anticoagulants."( Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials.
Coleman, CI; Crivera, C; Fields, LE; Nguyen, E; Patel, MR; Peacock, WF; White, CM, 2016
)
0.75
" However, primary care physicians seem to be hesitant to accept the concept of a fixed-dose regimen for patients at extremes of weight, perhaps because of familiarity with weight-based dosing of other drugs including low molecular weight heparins."( Management of rivaroxaban in relation to bodyweight and body mass index.
Uprichard, J, 2016
)
0.79
" Pre-dialysis dosing resulted in only 5% lowering of AUC versus post-dialysis dosing, confirming the minimal impact of dialysis on the PK of rivaroxaban."( Pharmacokinetics, Pharmacodynamics, and Safety of Single-Dose Rivaroxaban in Chronic Hemodialysis.
Ariyawansa, J; Dias, C; Mills, RM; Moore, KT; Murphy, J; Smith, W; Weir, MR, 2016
)
0.88
"All the newer oral anticoagulants compared were more effective than adjusted dosed warfarin."( Cost-Effectiveness of Oral Anticoagulants for Ischemic Stroke Prophylaxis Among Nonvalvular Atrial Fibrillation Patients.
Hayes, CJ; Martin, BC; Shah, A; Shewale, A, 2016
)
0.43
"Because some patients have difficulty swallowing a whole tablet, we investigated the relative bioavailability of a crushed 20 mg rivaroxaban tablet and of 2 alternative crushed tablet dosing strategies."( Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
Damaraju, CV; Fields, LE; Krook, MA; Moore, KT; Sarich, TC; Vaidyanathan, S, 2014
)
2.05
" Relative bioavailability was similar between Crushed-Oral and Reference dosing (Cmax and AUC∞ were within the 80-125% bioequivalence limits)."( Rivaroxaban crushed tablet suspension characteristics and relative bioavailability in healthy adults when administered orally or via nasogastric tube.
Damaraju, CV; Fields, LE; Krook, MA; Moore, KT; Sarich, TC; Vaidyanathan, S, 2014
)
1.85
" However the peri-procedural dosing protocols used in various studies especially in terms of whether NOAC use is interrupted or uninterrupted during AF ablation, have significant inter-operator and inter-institution variability."( Are Some Anticoagulants More Equal Than Others? - Evaluating the Role of Novel Oral Anticoagulants in AF Ablation.
Fox, DJ; Sankaranarayanan, R,
)
0.13
" Because he had a reduced creatinine clearance of 44mL/min, his dosage of rivaroxaban was reduced from 15 to 10mg daily according to official Japanese prescribing information."( Intracranial subdural hematomas with elevated rivaroxaban concentration and subsequently detected spinal subdural hematoma: A case report.
Hino, T; Koga, M; Matsuki, T; Toyoda, K; Yamaguchi, Y; Yokota, C, 2016
)
0.92
" Susoctocog alfa offers the ability to effectively titrate and monitor dosing based on factor VIII activity levels."( [Coagulation disorders in the intensive care unit - what is new?].
Hart, C; Schmid, S, 2016
)
0.43
" Nonetheless, the absence of the ability for clinicians to assess compliance or washout with a simple laboratory test (or to adjust dosing with a similar assessment) and the absence of an antidote to rapidly stop major hemorrhage or to enhance safety in the setting of emergent or urgent surgery/procedures have been limitations to greater non-vitamin K antagonist oral anticoagulant usage and better thromboembolic prevention."( NOAC monitoring, reversal agents, and post-approval safety and effectiveness evaluation: A cardiac safety research consortium think tank.
Kaminskas, E; Reiffel, JA; Reilly, P; Sager, P; Sarich, T; Seltzer, J; Weitz, JI, 2016
)
0.43
" Differences in the ACT before ablation and adequate initial heparin dosing in patients receiving non-vitamin K antagonist oral anticoagulants (NOACs) were examined."( Adequate Initial Heparin Dosage for Atrial Fibrillation Ablation in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants.
Higashiya, S; Hina, K; Kamikawa, S; Kawamura, H; Komtasubara, I; Kusachi, S; Murakami, M; Murakami, T; Yamaji, H, 2016
)
0.43
" In addition to familiarity with the dosing and monitoring of vitamin K antagonists, clinicians are accustomed to using vitamin K if there is a need to reverse the anticoagulant effect of vitamin K antagonists."( Management of Bleeding With Non-Vitamin K Antagonist Oral Anticoagulants in the Era of Specific Reversal Agents.
Antman, EM; Giugliano, RP; Ruff, CT, 2016
)
0.43
" If the dosage of the drug is not available, proposals are based on the combination of a PT ≥80% and an aPTT ≤1."( PT, aPTT, TT and the hemostatic safety threshold of dabigatran and rivaroxaban.
Calmette, L; Flaujac, C; Gouin-Thibault, I; Horellou, MH; Ibrahim, F; Layka, A; Mazoyer, É, 2016
)
0.67
" Outcome measures were dosing errors if GFR were to be substituted for CrCL-CG."( Potential Effect of Substituting Estimated Glomerular Filtration Rate for Estimated Creatinine Clearance for Dosing of Direct Oral Anticoagulants.
Schwartz, JB, 2016
)
0.43
" At a CrCL-CG of less than 30 mL/min, GFR estimates missed indicated dosage reductions for dabigatran in 18% to 21% of NHANES subjects and 57% to 86% of research subjects."( Potential Effect of Substituting Estimated Glomerular Filtration Rate for Estimated Creatinine Clearance for Dosing of Direct Oral Anticoagulants.
Schwartz, JB, 2016
)
0.43
" With similar efficacy, better safety, and the convenience of fixed dosing without the need for routine coagulation monitoring, guidelines now recommend DOACs over VKAs for VTE treatment in patients without active cancer."( Optimizing the safety of treatment for venous thromboembolism in the era of direct oral anticoagulants.
Jaffer, IH; Weitz, JI, 2016
)
0.43
" We collected data on type and dosage of anticoagulation; suspected or confirmed bleeding events, hospital admissions, and mortality; and pattern and management of vaginal bleeding events."( Management and outcomes of vaginal bleeding and heavy menstrual bleeding in women of reproductive age on direct oral anti-factor Xa inhibitor therapy: a case series.
Beyer-Westendorf, J; Hauswald-Dörschel, S; Marten, S; Michalski, F; Tittl, L, 2016
)
0.43
"43) at a dosage of 15 mg every 12 hours for 3 weeks, followed by 20 mg once daily for 3 months."( Successful use of rivaroxaban in postoperative deep vein thrombosis of the lower limb following instability with warfarin: a case report.
Coluccia, A; Schiavoni, M, 2016
)
0.77
" D-dimer and prothrombin fragment 1 + 2 (F1 + 2) levels, and protein C activities were measured at 0 (baseline), 12 and 24 weeks of rivaroxaban treatment just before the patient's regular dosing time (trough phase)."( Assessment of trough rivaroxaban concentrations on markers of coagulation activation in nonvalvular atrial fibrillation population.
Harada, M; Hayashi, M; Hiramitsu, S; Ishii, J; Izawa, H; Kawai, H; Kitagawa, F; Matsui, S; Motoyama, S; Muramatsu, T; Naruse, H; Okuyama, R; Ozaki, Y; Sarai, M; Takahashi, H; Watanabe, E, 2017
)
0.98
"Compared to enoxaparin (most commonly dosed 40 mg once daily), the relative risk (RR) of VTE was lowest for edoxaban 30 mg once daily (0."( Safety and Efficacy of New Anticoagulants for the Prevention of Venous Thromboembolism After Hip and Knee Arthroplasty: A Meta-Analysis.
Gage, BF; Ganti, BR; Lee, ED; Lin, H; Nunley, RM; Venker, BT, 2017
)
0.46
"Direct oral anticoagulants currently have no indication for monitoring even though there are data that imply that individual dosing can improve and add safety to the therapy."( Development of an UHPLC-UV-Method for Quantification of Direct Oral Anticoagulants: Apixaban, Rivaroxaban, Dabigatran, and its Prodrug Dabigatran Etexilate in Human Serum.
Boehr, S; Haen, E, 2017
)
0.67
" Rivaroxaban was prescribed at a dosage of 15 mg in 37."( [Real life clinical management of nonvalvular atrial fibrillation: results from the Italian epidemiological survey eXperience on the use of rivaroxaban].
Ammirati, F; Colonna, P, 2016
)
1.55
" Rivaroxaban dosage was determined according to creatinine clearance (CrCl): 10 and 15mg once daily for patients with CrCl 15-49 and CrCl ≥50mL/min, respectively."( Monitoring of anti-Xa activity and factors related to bleeding events: A study in Japanese patients with nonvalvular atrial fibrillation receiving rivaroxaban.
Ajioka, M; Asano, H; Inden, Y; Ishii, H; Murase, Y; Murohara, T; Nakashima, Y; Osanai, H; Sakaguchi, T; Sakai, K; Suzuki, S; Takefuji, M, 2017
)
1.57
" DOACs have a wide therapeutic range that allows fixed dosing determined based on studies conducted in healthy subjects with normal absorptive capacity."( Effect of major gastrointestinal tract surgery on the absorption and efficacy of direct acting oral anticoagulants (DOACs).
Al-Sanea, N; Hakeam, HA, 2017
)
0.46
" We sought to examine the determinants of heparin dosing in this patient population."( Determinants of Heparin Dosing and Complications in Patients Undergoing Left Atrial Ablation on Uninterrupted Rivaroxaban.
Barbhaiya, CR; Chinitz, JS; Churchill, T; Enriquez, AD; Gautam, S; John, RM; Koplan, BA; Kumar, S; Michaud, GF; Stevenson, WG; Tedrow, UB, 2017
)
0.67
"Surgical procedures under NOACS can be scheduled at the beginning of next dosing interval or omitted in low/minimal bleeding risk patients, so that only 2-3 NOAC doses are not administered."( [Management of NOAK administration during invasive or surgical interventions : When and how to pause and when to restart?]
Buerke, M; Hoffmeister, HM, 2017
)
0.46
" Data from the phase III rivaroxaban studies presented here show that a 21-day intensive dosing regimen of rivaroxaban 15 mg twice daily is effective during the acute treatment phase for VTE, with similar recurrence rates and thrombus resolution to standard anticoagulation."( Overview of Current Evidence on the Impact of the Initial High Dose of the Direct Factor Xa Inhibitor Rivaroxaban on Thrombus Resolution in the Treatment of Venous Thromboembolism.
Bauersachs, R; Koitabashi, N, 2017
)
0.97
" To ensure responsible use of these agents, every hospital needs a bleeding management algorithm that identifies patients eligible for reversal and outlines appropriate dosing regimens."( Reversal of Direct Oral Anticoagulants: Current Status and Future Directions.
Weitz, JI, 2017
)
0.46
" The fact that the NOACs don't require routine monitoring to assure that patients remain within the therapeutic range and have relatively simple dosing requirements and a safer risk profile makes them attractive substitutes to warfarin in HF patients with atrial fibrillation and other conditions (e."( Anticoagulation Therapy and NOACs in Heart Failure.
EncisoSilva, J; Greenberg, B; Schlueter, M; Thomas, I, 2017
)
0.46
" Our review of the available literature indicates that the clinical profile of the DOAC rivaroxaban is not affected by high weight or bariatric surgery; hence, it does not appear that rivaroxaban dosing needs to be altered in these patient populations."( Influences of Obesity and Bariatric Surgery on the Clinical and Pharmacologic Profile of Rivaroxaban.
Kröll, D; Moore, KT, 2017
)
0.9
" The objective is to present a case report that illustrates there may be important dosing issues when considering the use of these agents in patients with the antiphospholipid syndrome."( Dosing considerations in the use of the direct oral anticoagulants in the antiphospholipid syndrome.
Hassell, K; Schofield, JR, 2018
)
0.48
"Despite a similar half-life, pharmacokinetics and pharmacodynamics, the manufacturer-recommended maintenance dosing of apixaban is twice daily and rivaroxaban once daily."( Dosing considerations in the use of the direct oral anticoagulants in the antiphospholipid syndrome.
Hassell, K; Schofield, JR, 2018
)
0.68
"We compared NOACs (as a group) to warfarin in non-valvular atrial fibrillation, studying all 12,694 patients starting NOAC treatment within the Swedish clinical register and dosing system Auricula, from July 1, 2011 to December 31, 2014, and matching them to 36,317 patients starting warfarin using propensity scoring."( Non-vitamin K oral anticoagulants are non-inferior for stroke prevention but cause fewer major bleedings than well-managed warfarin: A retrospective register study.
Byström, B; Norrving, B; Oldgren, J; Renlund, H; Själander, A; Sjögren, V; Svensson, PJ, 2017
)
0.46
" Identification of additional clinical and molecular determinants that more fully predict patients at risk for excessively high or low DOAC concentrations may enable a more precise DOAC dosing regimen for the individual patient."( Interpatient Variation in Rivaroxaban and Apixaban Plasma Concentrations in Routine Care.
Alfonsi, JE; Dresser, GK; Gryn, SE; Gulilat, M; Henderson, SL; Kim, RB; Leong-Sit, P; Lizotte, DJ; Rose, RV; Schwarz, UI; Skanes, AC; Tang, A; Teft, WA; Tirona, RG, 2017
)
0.76
" Further investigations are needed to determine the optimal dosage of rivaroxaban."( The Successful Prevention of Thromboembolism Using Rivaroxaban in a Patient with Antithrombin Deficiency during the Perioperative Period.
Ando, K; Kawada, H; Kawai, H; Matsushita, H; Ogawa, Y, 2017
)
0.94
"The anticoagulant effect of rivaroxaban, a direct inhibitor of activated factor X (FX), might be influenced by its dosing time because the activity of the coagulofibrinolytic system exhibits daily rhythmicity."( Dosing-time-dependent effect of rivaroxaban on coagulation activity in rats.
Ando, H; Fujimura, A; Fujiwara, Y; Horiguchi, M; Ushijima, K; Yamashita, C, 2017
)
1.03
"To assess DOAC dosing appropriateness and its effect on clinical outcomes in NVAF patients."( Effect of Renal Function on Dosing of Non-Vitamin K Antagonist Direct Oral Anticoagulants Among Patients With Nonvalvular Atrial Fibrillation.
Baser, O; Kwong, WJ; Shrestha, S, 2018
)
0.48
" DOAC dosage was classified as inappropriate or appropriate by level of renal function, age, and body weight per US prescription information."( Effect of Renal Function on Dosing of Non-Vitamin K Antagonist Direct Oral Anticoagulants Among Patients With Nonvalvular Atrial Fibrillation.
Baser, O; Kwong, WJ; Shrestha, S, 2018
)
0.48
"8%) were inappropriately dosed, and rivaroxaban had the highest inappropriate dosing rate."( Effect of Renal Function on Dosing of Non-Vitamin K Antagonist Direct Oral Anticoagulants Among Patients With Nonvalvular Atrial Fibrillation.
Baser, O; Kwong, WJ; Shrestha, S, 2018
)
0.76
"Inappropriate dosing occurred among patients with normal and insufficient renal function."( Effect of Renal Function on Dosing of Non-Vitamin K Antagonist Direct Oral Anticoagulants Among Patients With Nonvalvular Atrial Fibrillation.
Baser, O; Kwong, WJ; Shrestha, S, 2018
)
0.48
" Off-label indications and dosage too low were the most common not per protocol reasons for apixaban and rivaroxaban prescriptions."( Comparison of Prescribing Practices with Direct Acting Oral Anticoagulant Protocols.
Carley, B; Draper, E; Griesbach, S; Krueger, K; Larson, T; Parkhurst, B, 2017
)
0.67
"Once-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) may increase patient adherence to treatment but may also be associated with a higher risk of bleeding."( Safety of once- or twice-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) in patients with nonvalvular atrial fibrillation: A NOAC-TR study.
Akyüz, A; Başaran, Ö; Berilgen, R; Çelik, O; Çetin, N; Coşar, S; Dereli, Y; Doğan, T; Doğan, V; Emren, SV; Enhoş, A; Ergene, O; Gürsul, E; İnci, S; Karaca, I; Karaca, Ö; Köseoğlu, C; Levent, F; Onrat, E; Otlu, YÖ; Özdemir, İH; Özmen, Ç; Sümerkan, M; Zoghi, M, 2018
)
0.48
" Appropriateness was evaluated based on approved dosing and indications in Canada and the United States."( Appropriateness of Dabigatran and Rivaroxaban Prescribing in Qatar: A 5-Year Experience.
Ali, Z; El-Makaty, H; Elewa, H, 2018
)
0.76
"3%) patients, while inappropriate dosing was found in 352 (33."( Appropriateness of Dabigatran and Rivaroxaban Prescribing in Qatar: A 5-Year Experience.
Ali, Z; El-Makaty, H; Elewa, H, 2018
)
0.76
" While efficacious, they are difficult to use due to interpatient dose-response variability and the risks of bleeding."( Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
Fischer, PM, 2018
)
0.48
"The direct oral anticoagulants (DOACs), also referred to as novel (or non-vitamin K antagonist) oral anticoagulants (NOACs), represent a major development in anticoagulation therapy due to their rapid onset of action, predictable dose-response with fixed doses and limited interactions with food and drugs."( An update on the bleeding risks associated with DOACs.
, 2017
)
0.46
" Modification of recommended dosage may be required in this combination of circumstances to reduce risk to patients."( Impaired Rivaroxaban Clearance in Mild Renal Insufficiency With Verapamil Coadministration: Potential Implications for Bleeding Risk and Dose Selection.
Chow, CR; Greenblatt, DJ; Harmatz, JS; Nicholson, WT; Patel, M; Rubino, CM, 2018
)
0.9
"Current dosing recommendations for rivaroxaban advocate dosage reduction in patients with moderate to severe renal impairment and avoidance of concomitant strong inhibitors of CYP3A or P-glycoprotein."( Minimal Physiologically Based Pharmacokinetic and Drug-Drug-Disease Interaction Model of Rivaroxaban and Verapamil in Healthy and Renally Impaired Subjects.
Chow, CR; Ismail, M; Lee, VH; Rubino, CM, 2018
)
0.98
"In this review we present comparison of pharmacokinetics of novel oral anticoagulants (NOAC) dabigatran, rivaroxaban, apixaban, and edoxaban, principles of selection of a regimen of their dosing for phase III clinical trials in patients with atrial fibrillation."( [Clinico-Pharmacological and Clinical Basis of Multiplicity of Intake of Novel Oral Anticoagulants].
Levanov, AN; Sinitsina, II; Sychev, DA; Tsomaya, IV; Vardanyan, AV, 2017
)
0.67
" Real-world evidence indicates superior rates of drug adherence with rivaroxaban when compared with vitamin K antagonists and with alternative non-vitamin K oral anticoagulants - perhaps, in part, due to its once-daily dosing regimen."( Role of rivaroxaban in the management of atrial fibrillation: insights from clinical practice.
Dockrill, SJ; Gorog, DA; Vimalesvaran, K, 2018
)
1.15
" Drug dosage changes and serum creatinine determinations were recorded during 1-year follow-up."( Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation.
Albendin Iglesias, H; Andreu Cayuelas, JM; Bailen Lorenzo, JL; Caro Martínez, C; Cerezo Manchado, JJ; Elvira Ruiz, G; Flores Blanco, PJ; García Alberola, A; Januzzi, JL; Manzano-Fernández, S, 2018
)
0.48
" Compliance with kidney function monitoring recommendations was associated with adequate NOAC dosage at 1-year follow-up."( Kidney function monitoring and nonvitamin K oral anticoagulant dosage in atrial fibrillation.
Albendin Iglesias, H; Andreu Cayuelas, JM; Bailen Lorenzo, JL; Caro Martínez, C; Cerezo Manchado, JJ; Elvira Ruiz, G; Flores Blanco, PJ; García Alberola, A; Januzzi, JL; Manzano-Fernández, S, 2018
)
0.48
"The objective of this study is to evaluate the effectiveness of different rivaroxaban dosage regimens in preventing ischemic stroke and systemic thromboembolism among Asians."( Effectiveness and Safety of Different Rivaroxaban Dosage Regimens in Patients with Non-Valvular Atrial Fibrillation: A Nationwide, Population-Based Cohort Study.
Cheng, SH; Huang, HY; Lin, SY; Wang, CC, 2018
)
0.98
" Initial dosing was according to label in over 90% of patients and persistence to rivaroxaban therapy was adequate with low rates of unplanned complete discontinuation."( Venous thromboembolism therapy with rivaroxaban in daily-care patients: Results from the Dresden NOAC registry.
Beyer-Westendorf, J; Hecker, J; Keller, L; Marten, S; Sahin, K; Tittl, L, 2018
)
0.98
"There is limited evidence on patients' adherence and the impact of the prescribed dosing regimen in non-vitamin-K oral anticoagulants (NOACs)."( Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands.
de Boer, PT; Hoffmann, M; Jacobs, MS; Levin, LÅ; Postma, MJ; Schouten, JF, 2018
)
0.48
" Patients using a consistent dosage for at least 180 consecutive days were included."( Secondary adherence to non-vitamin-K antagonist oral anticoagulants in patients with atrial fibrillation in Sweden and the Netherlands.
de Boer, PT; Hoffmann, M; Jacobs, MS; Levin, LÅ; Postma, MJ; Schouten, JF, 2018
)
0.48
"Direct acting non-Vitamin K antagonist oral anticoagulants (NOAC) are characterized by a fixed dosing regimen."( Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119).
Beyer-Westendorf, I; Beyer-Westendorf, J; Endig, S; Marten, S; Reitter, A; Tittl, L, 2018
)
0.48
" Future directions include identification of clinically relevant SNPs, and change in optimum dosage for patients who are carriers of significant variants."( Pharmacogenetics of novel oral anticoagulants: a review of identified gene variants & future perspectives.
Ašić, A; Marjanović, D; Mirat, J; Primorac, D, 2018
)
0.48
"A favorable clinical profile with rivaroxaban was observed across age sub-groups, supporting the premise that dosing in older adults does not necessitate adjustment."( Influence of age on the pharmacokinetics, pharmacodynamics, efficacy, and safety of rivaroxaban.
Foody, J; Moore, KT; Pan, G; Wong, P; Zhang, L, 2018
)
0.98
" Ten of 39 patients (26%) were not receiving a DOAC dosage consistent with the package insert."( Evaluation of direct oral anticoagulants for the treatment of venous thromboembolism in the oncology population.
Hedvat, J; Howlett, C; McCloskey, J; Patel, R, 2018
)
0.48
"The inpatient is a 41-year-old morbidly obese male with schizoaffective disorder whose clozapine dosage was titrated from 100 mg to 175 mg due to auditory hallucination and agitation."( Excited catatonia in a patient with fatal pulmonary embolism and a successful treatment strategy.
Huang, TL; Tseng, WT, 2018
)
0.48
" Current recommendations state that coagulation monitoring is not required, and neither the dose nor dosing interval requires adjustment in response to changes in coagulation parameters when rivaroxaban is used for approved indications."( Routine coagulation test abnormalities caused by rivaroxaban: A case report.
Cao, H; Qin, L; Song, Z; Tang, M; Wu, H; Yang, S, 2018
)
0.93
" Multivariable adjusted Cox models stratified by dosage estimated hazard ratios (aHR)."( Dabigatran Versus Rivaroxaban for Secondary Stroke Prevention in Patients with Atrial Fibrillation Rehabilitated in Skilled Nursing Facilities.
Alcusky, M; Fisher, M; Goldberg, RJ; Hume, AL; Lapane, KL; McManus, DD; Tjia, J, 2018
)
0.81
" This analysis of the XANTUS study assessed outcomes associated with non-recommended dosing and patient characteristics that may have impacted dose choice."( Outcomes associated with non-recommended dosing of rivaroxaban: results from the XANTUS study.
Amarenco, P; Bach, M; Camm, AJ; Haas, S; Hess, S; Kirchhof, P; Lambelet, M; Turpie, AGG, 2019
)
0.77
"Non-recommended rivaroxaban dosing was associated with less favourable outcomes, possibly due to baseline characteristics, in addition to renal function, that may also affect physicians' dosing decisions."( Outcomes associated with non-recommended dosing of rivaroxaban: results from the XANTUS study.
Amarenco, P; Bach, M; Camm, AJ; Haas, S; Hess, S; Kirchhof, P; Lambelet, M; Turpie, AGG, 2019
)
1.11
" The goal of our study was to evaluate the outcomes of our reduced dosing strategy with FEIBA in patients experiencing a DOAC-related bleeding event."( Effect of low and moderate dose FEIBA to reverse major bleeding in patients on direct oral anticoagulants.
Dager, WE; Nishijima, DK; Roberts, AJ, 2019
)
0.51
"Apixaban and rivaroxaban, both direct-acting oral anticoagulants, are being increasingly used in routine clinical practice because of their fixed dosing and favourable pharmacological profiles."( Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis.
Brown, J; Dawwas, GK; Dietrich, E; Park, H, 2019
)
1.14
" The observed effect could be a secondary consequence of dosage control or alternatively a result of different anticoagulant effects among the different medications."( Higher Incidence of Ischemic Stroke in Patients Taking Novel Oral Anticoagulants.
Cowperthwaite, M; Fanale, C; Nadasdy, Z; Ramakrishnan, A; Shpak, M, 2018
)
0.48
"In the past decade, direct-acting oral anticoagulants (DOAC) have been introduced to medical practice for several indications, with a wide range of dosing regimens."( Clinical pharmacist led hospital-wide direct oral anticoagulant stewardship program.
Aldouby-Bier, G; Fisher Negev, T; Hirsh-Raccah, B; Hochberg-Klein, S; Horwitz, E; Kalish, Y; Muszkat, M; Perlman, A, 2019
)
0.51
" Most patients who received rivaroxaban were appropriately selected, received the correct dosing schedule, reported few adverse effects."( XALIA-LEA: An observational study of venous thromboembolism treatment with rivaroxaban and standard anticoagulation in the Asia-Pacific, Eastern Europe, the Middle East, Africa and Latin America.
Ageno, W; Bugge, JP; Gebel, M; Haas, S; Kreutz, R; Mantovani, LG; Monje, D; Schneider, J; Tamm, M; Turpie, AGG, 2019
)
1.04
" Single PO and 3 consecutive dosing regimens also were assessed."( Therapeutic monitoring of rivaroxaban in dogs using thromboelastography and prothrombin time.
Bae, J; Jung, DI; Kim, H; Kim, S; Kim, W; Park, J; Yu, D, 2019
)
0.81
" dosing interval) or patient experiences while on treatment."( Real-world adherence for direct oral anticoagulants in a newly diagnosed atrial fibrillation cohort: does the dosing interval matter?
Brown, JD; Pham, PN, 2019
)
0.51
"Apixaban users had the highest overall adherence despite twice-daily dosing versus once-daily dosing for rivaroxaban."( Real-world adherence for direct oral anticoagulants in a newly diagnosed atrial fibrillation cohort: does the dosing interval matter?
Brown, JD; Pham, PN, 2019
)
0.73
" Furthermore, we evaluated the appropriateness of labeled and off-label dosing implemented for 348 patients using the obtainable PC threshold."( Rivaroxaban or Apixaban for Non-Valvular Atrial Fibrillation - Efficacy and Safety of Off-Label Under-Dosing According to Plasma Concentration.
Kino, M; Morii, I; Suwa, M, 2019
)
1.96
" Benefits of direct oral anticoagulants include a rapid onset of therapeutic effect, fixed dose-response relationships without the need for routine monitoring, a short half-life, and infrequent need for periprocedural bridging with a parenteral agent."( Direct Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation: Update and Periprocedural Management.
Pickett, JD, 2019
)
0.51
"In plasma systems, the assay demonstrates dose-response between 0 and 5 nmol/L rivaroxaban and between 0 and 10 nmol/L apixaban."( An assay to measure levels of factor Xa inhibitors in blood and plasma.
Di Giuseppantonio, LR; Douketis, JD; Gross, PL; Kim, PY; Wu, C, 2019
)
0.74
"It is unclear whether the two once-daily dosing non-vitamin K antagonist oral anticoagulants (NOACs), edoxaban and rivaroxaban, have similar effectiveness and safety in Asian patients with non-valvular atrial fibrillation (AF)."( Comparison of Once-Daily Administration of Edoxaban and Rivaroxaban in Asian Patients with Atrial Fibrillation.
Choi, EK; Han, KD; Jung, JH; Lee, SR; Lip, GYH; Oh, S, 2019
)
0.97
" Andexanet alfa is administered via two different dosing regimens, standard and high dose, based on the specific FXa inhibitor, dose, and time since the patient's last dose of FXa inhibitor."( Andexanet Alfa (Andexxa) Formulary Review.
Beik, N; Connell, NT; Connors, JM; Giugliano, RP; Piazza, G; Reddy, P; Sylvester, KW, 2019
)
0.51
" In Part A, rivaroxaban pharmacokinetics, pharmacodynamics, safety, and tolerability are assessed to validate the pediatric dosing selected."( Rivaroxaban, a direct Factor Xa inhibitor, versus acetylsalicylic acid as thromboprophylaxis in children post-Fontan procedure: Rationale and design of a prospective, randomized trial (the UNIVERSE study).
Bonnet, D; Dong, X; Harris, KC; Jefferies, J; Justino, H; Li, JS; McCrindle, BW; Michelson, AD; Pina, LM; Samtani, MN; Zhang, L, 2019
)
2.34
" The aim of the present study was to compare the risks of ischemic stroke, intracranial hemorrhage, and net clinical benefit of Asian patients with AF treated with off-label low-dose and on-label dosing rivaroxaban."( Low-Dose Rivaroxaban and Risks of Adverse Events in Patients With Atrial Fibrillation.
Chang, SL; Chao, TF; Chen, SA; Cheng, WH; Chung, FP; Hu, YF; Liao, JN; Lin, YJ; Lip, GYH; Lo, LW; Tuan, TC, 2019
)
1.12
"Appropriate dosing of direct oral anticoagulants (DOACs) requires consideration of renal function."( Renal Function Estimates and Dosing of Direct Oral Anticoagulants in Stroke Patients with Atrial Fibrillation: An Observational Study.
Chen, YT; Lin, HJ, 2018
)
0.48
"Although substituting eGFR for CrCl carries potential risks of DOAC overdosing in patients with AF, the effect might be offset by clinicians' predilection for lower dosage in this stroke cohort."( Renal Function Estimates and Dosing of Direct Oral Anticoagulants in Stroke Patients with Atrial Fibrillation: An Observational Study.
Chen, YT; Lin, HJ, 2018
)
0.48
"The aim of this study was to analyze the adherence to current labeling concerning initial rivaroxaban dosing and to determine whether potential lack of such adherence is medically justified."( Initial rivaroxaban dosing in patients with atrial fibrillation.
Ablefoni, K; Bollmann, A; Buchholz, A; Dagres, N; Hilbert, S; Hindricks, G; Husser, D; Ueberham, L, 2019
)
1.17
"In clinical practice, rivaroxaban dosing is frequently incoherent with labeling."( Initial rivaroxaban dosing in patients with atrial fibrillation.
Ablefoni, K; Bollmann, A; Buchholz, A; Dagres, N; Hilbert, S; Hindricks, G; Husser, D; Ueberham, L, 2019
)
1.26
" We administered rivaroxaban orally in a bodyweight-adjusted 20 mg-equivalent dose, based on physiologically-based pharmacokinetic modelling predictions and EINSTEIN-Jr phase 1 data in young adults, in either a once-daily (tablets; for those aged 6-17 years), twice-daily (in suspension; for those aged 6 months to 11 years), or three times-daily (in suspension; for those younger than 6 months) dosing regimen for 30 days (or 7 days for those younger than 6 months)."( Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies.
Becka, M; Beyer-Westendorf, J; Connor, P; Grangl, G; Halton, J; Holzhauer, S; Kapsa, S; Kenet, G; Kubitza, D; Kumar, R; Lensing, AWA; Male, C; Martinelli, I; Molinari, AC; Monagle, P; Nowak-Göttl, U; Pap, AF; Prins, MH; Robertson, J; Samochatova, E; Santamaría, A; Saracco, P; Simioni, P; Thelen, K; Twomey, T; Willmann, S; Young, G, 2019
)
1.18
" We confirmed therapeutic rivaroxaban exposures with once-daily dosing in children with bodyweights of at least 30 kg and with twice-daily dosing in children with bodyweights of at least 20 kg and less than 30 kg."( Bodyweight-adjusted rivaroxaban for children with venous thromboembolism (EINSTEIN-Jr): results from three multicentre, single-arm, phase 2 studies.
Becka, M; Beyer-Westendorf, J; Connor, P; Grangl, G; Halton, J; Holzhauer, S; Kapsa, S; Kenet, G; Kubitza, D; Kumar, R; Lensing, AWA; Male, C; Martinelli, I; Molinari, AC; Monagle, P; Nowak-Göttl, U; Pap, AF; Prins, MH; Robertson, J; Samochatova, E; Santamaría, A; Saracco, P; Simioni, P; Thelen, K; Twomey, T; Willmann, S; Young, G, 2019
)
1.14
" However, the complexity of DOAC dose regimens can still lead to dosing errors and potential bleeding-related or thromboembolic adverse events, especially in the elderly."( Burden of Inappropriate Prescription of Direct Oral Anticoagulants at Hospital Admission and Discharge in the Elderly: A Prospective Observational Multicenter Study.
Anfosso, M; Bruneau, A; Fernandez, C; Hindlet, P; Schwab, C, 2019
)
0.51
" The survey included questions regarding centers' demographics and posed a series of hypothetical clinical scenarios to gather centers' VTE treatment practices including choice of anticoagulant, dosing practices, duration decisions, and monitoring efforts."( Survey of current treatment practices for venous thromboembolism in patients with cystic fibrosis.
Jones, AE; Ratté, MT; Witt, DM; Young, DC, 2020
)
0.56
" Increasing the duration of anticoagulation, determining the optimal dosage of anticoagulants, and switching to another anticoagulant when necessary could be considered to improve treatment effectiveness."( Outcome of Anticoagulation Therapy of Left Atrial Thrombus or Sludge in Patients With Nonvalvular Atrial Fibrillation or Flutter.
Dong, J; Du, X; Ma, C; Yang, Y, 2019
)
0.51
" Most patients who were taking NOACs had excellent adherence regardless of the dosing frequency."( NOAC Adherence of Patients with Atrial Fibrillation in the Real World: Dosing Frequency Matters?
Bae, HJ; Cho, YK; Choi, SW; Han, S; Hur, SH; Hwang, J; Jun, SW; Kim, H; Kim, IC; Lee, CH; Lee, SH; Nam, CW; Park, HS; Yoon, HJ, 2020
)
0.56
" The purpose of this study was to assess the impact of the route of administration and dosage regimen on the compliance to the prescription."( Extended thromboprophylaxis for hip or knee arthroplasty. Does the administration route and dosage regimen affect adherence? A cohort study.
Bautista, M; Bonilla, G; Castro, J; Llinás, A; Moreno, JP, 2020
)
0.56
" We sought to examine the determinants of heparin dosage in Chinese patients on rivaroxaban."( Effects of rivaroxaban on activated clotting time in catheter ablation for atrial fibrillation in Chinese patients.
Chunling, W; Jiang, C; Songqun, H; Xinmiao, H; Zhifu, G, 2020
)
1.17
" The dosage of heparin required to achieve ACT > 300 s was evaluated."( Effects of rivaroxaban on activated clotting time in catheter ablation for atrial fibrillation in Chinese patients.
Chunling, W; Jiang, C; Songqun, H; Xinmiao, H; Zhifu, G, 2020
)
0.95
" Heparin dosage can be predicted by baseline ACT, but not influenced by duration on or withdrawal of rivaroxaban."( Effects of rivaroxaban on activated clotting time in catheter ablation for atrial fibrillation in Chinese patients.
Chunling, W; Jiang, C; Songqun, H; Xinmiao, H; Zhifu, G, 2020
)
1.16
" In addition, apixaban and rivaroxaban offer more than one dosing option, allowing tailoring of treatment to the patient's specific risk factor profile."( Broadening the Categories of Patients Eligible for Extended Venous Thromboembolism Treatment.
Schindewolf, M; Weitz, JI, 2020
)
0.86
" Racial differences in pharmacokinetics, dosing requirements, drug response, and/or safety end points were identified for unfractionated heparin, enoxaparin, argatroban, warfarin, rivaroxaban, and edoxaban."( Racial and Ethnic Differences in Response to Anticoagulation: A Review of the Literature.
Gibson, CM; Yuet, WC, 2021
)
0.81
"We evaluated adherence to dosing criteria for patients with atrial fibrillation (AF) taking dabigatran or rivaroxaban and the impact of off-label dosing on thromboembolic and bleeding risk."( Characteristics and outcomes in patients with atrial fibrillation receiving direct oral anticoagulants in off-label doses.
Alvarez, P; Asleh, R; Briasoulis, A; Chrischilles, E; Gao, Y; Inampudi, C; Leira, EC; Vaughan-Sarrazin, M, 2020
)
0.77
" Using the Korean National Health Insurance Service database, we evaluated 16,568 patients with a new prescription of NOAC who are indicated for standard NOAC dosing and compared 4,536 patients with warfarin with respect to thromboembolic events (ischemic stroke or systemic embolization), all-cause mortality and major bleeding."( Pattern and Impact of Off-label Underdosing of Non-Vitamin K Antagonist Oral Anticoagulants in Patients With Atrial Fibrillation Who are Indicated for Standard Dosing.
Cho, MS; Kim, H; Kim, YJ; Lee, J; Nam, GB; Park, DW; Park, JJ; Yun, JE, 2020
)
0.56
"9%) patients receiving rivaroxaban were not initiated on the FDA-recommended 15 mg twice daily dosing for the first 21 days."( Use of apixaban and rivaroxaban in young adults with acute venous thromboembolism: a multi-center retrospective case series.
Barnes, GD; DeCamillo, D; Ellsworth, S; Kaatz, S, 2020
)
1.19
" The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling."( Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.
Amedro, P; Bajolle, F; Berkowitz, SD; Beyer-Westendorf, J; Chan, AKC; Connor, P; Hege, K; Holzhauer, S; Hooimeijer, HL; Kenet, G; Kubitza, D; Kumar, R; Lensing, AWA; Male, C; Martinelli, I; Massicotte, MP; Monagle, P; Nurmeev, I; Palumbo, JS; Price, V; Prins, MH; Santamaría, A; Schmidt, S; Smith, WT; Thelen, K; Torres, M; Willmann, S; Young, G, 2020
)
2.51
" Dosage recommendations are approved for all adult patients to receive either 15 mg or 20 mg once daily depending upon renal function."( Rivaroxaban Precision Dosing Strategy for Real-World Atrial Fibrillation Patients.
Cao, YC; Gehi, AK; Gonzalez, D; Herbert Patterson, J; Kashuba, A; Konicki, R; Powell, JR; Watkins, P; Weiner, D, 2020
)
2
" However, even if the same dose of rivaroxaban is taken, different pathophysiological characteristics of TD patients determine the differences in plasma concentrations between individuals, leading to the difficulties of dosage selection and plasma concentration control."( Quantitative analysis of direct oral anticoagulant rivaroxaban by terahertz spectroscopy.
Cao, J; Chen, X; Peng, Y; Shi, Y; Wang, L; Wu, F; Wu, W; Wu, X; Xing, M; Yang, H; Zhu, Y; Zhuang, S, 2020
)
1.09
" Exposure-response relationships were evaluated using multivariate logistic and Cox regression for the twice-daily (BID) and once-daily (OD) dosing periods, respectively."( Associations between model-predicted rivaroxaban exposure and patient characteristics and efficacy and safety outcomes in the treatment of venous thromboembolism.
Berkowitz, SD; Fox, KAA; Garmann, D; Mueck, W; Peters, G; Reinecke, I; Schmidt, S; Solms, A; Spiro, TE; Weitz, JI; Willmann, S; Zhang, L, 2020
)
0.83
" However, warfarin requires regular monitoring and dosage adjustments and fails for many patients, causing thromboembolic and bleeding events."( Factor Xa inhibitors in patients with continuous-flow left ventricular assist devices.
Delgado, RM; Fedson, S; Frazier, OH; George, JK; Lamba, HK; Moctezuma-Ramirez, A; Nair, AP; Parikh, UM; Parikh, VY, 2020
)
0.56
"To review the literature on treatment of venous thromboembolism (VTE) and prevention of cardioembolic stroke with direct-acting oral anticoagulants (DOACs) in low- and high-body-weight patients and to make recommendations regarding agent selection and dosing in these patient populations."( Direct-acting oral anticoagulant use at extremes of body weight: Literature review and recommendations.
Branam, DL; Covert, K, 2020
)
0.56
"The selection and optimal dosing of DOACs in low- and high-body-weight patients has not yet been fully elucidated by clinical trials; however, evidence suggests that issues of both safety and efficacy in patients at the extremes of body weight may warrant careful consideration when selecting a DOAC for such patients."( Direct-acting oral anticoagulant use at extremes of body weight: Literature review and recommendations.
Branam, DL; Covert, K, 2020
)
0.56
" Prospective studies are needed to identify a superior reversal agent when comparing andexanet alfa to hospital standard of care (4F-PCC or aPCC) and to further explore the optimal dosing strategy for patients with ICH associated with apixaban or rivaroxaban use."( Treatment of adults with intracranial hemorrhage on apixaban or rivaroxaban with prothrombin complex concentrate products.
Atallah, S; Baje, M; Cang, W; Castillo, R; Chan, A; Derry, K; Groysman, L; Huang, W; Martin, R; Minokadeh, A; Nova, A; Schomer, K; Stern-Nezer, S; Zimmermann, LL, 2021
)
1.04
" Mean aPCC dosing was 2974 IU (SD ± 857 IU)."( Activated prothrombin complex concentrates for direct oral anticoagulant-associated bleeding or urgent surgery: Hemostatic and thrombotic outcomes.
Buyukdere, H; Carrier, M; Castellucci, LA; Chakraborty, S; Dowlatshahi, D; Shaw, JR; Tokessy, M, 2020
)
0.56
" Given the favourable safety profile of NOACs (especially if a reduced dosage of Apixaban or Rivaroxaban is initiated after at least six months of therapeutic anticoagulation), extended oral anticoagulation of indefinite duration should be considered for all patients with intermediate risk of recurrence."( [Antithrombotic Treatment of Pulmonary Embolism].
Ebner, M; Lankeit, M, 2020
)
0.78
" For low-risk procedures, age ≥75 years, female sex, a creatinine clearance (CrCl) <50 mL/min, and an interruption of <36 hours were associated with a greater likelihood of levels ≥30 ng/mL, whereas age ≥75 years, female sex, a CrCl of <50 mL/min, and standard DOAC dosing were associated with levels ≥50 ng/mL."( Predictors of preprocedural direct oral anticoagulant levels in patients having an elective surgery or procedure.
Coppens, M; Douketis, JD; Duncan, J; Li, N; Radwi, M; Schulman, S; Shaw, JR; Spyropoulos, AC; Syed, S; Vanassche, T, 2020
)
0.56
" Factors significantly associated with increased odds of bleeding were an age > 80 years, inappropriately high dosing regimens, and modest anti-Xa levels (100-300 ng/mL) for rivaroxaban specifically."( Apixaban and rivaroxaban anti-Xa level utilization and associated bleeding events within an academic health system.
Dinh, A; Donahue, KR; Jakowenko, N; Nguyen, S; Ruegger, M; Salazar, E, 2020
)
1.12
"Older age and inappropriately high dosing regimens were associated with major bleeding in patients taking apixaban and rivaroxaban."( Apixaban and rivaroxaban anti-Xa level utilization and associated bleeding events within an academic health system.
Dinh, A; Donahue, KR; Jakowenko, N; Nguyen, S; Ruegger, M; Salazar, E, 2020
)
1.14
" A growing body of evidence shows that once-daily dosing improves adherence and persistence to therapy, without having an impact on bleeding risk."( Non-Vitamin K Antagonist Oral Anticoagulants and Factors Influencing the Ischemic and Bleeding Risk in Elderly Patients With Atrial Fibrillation: A Review of Current Evidence.
Haas, S; Patti, G, 2020
)
0.56
" Thus, for example, rivaroxaban, an anticoagulant belonging to the class of direct-acting oral factor Xa inhibitors, provides a possibility to select an optimal dosage and regimen for a particular patient with arterial or vascular pathology in practice of a cardiovascular surgeon."( [Current concepts of anticoagulant and antiplatelet therapy in patients with vascular pathology].
Kuznetsov, MR; Sapelkin, SV, 2020
)
0.88
" Our study aimed to describe characteristics and dosing regimens in patients on apixaban or rivaroxaban who experienced a new or recurrent thrombosis."( Evaluation of characteristics and dosing regimens in patients with new or recurrent thrombosis on apixaban and rivaroxaban.
Donahue, KR; Dreucean, D; Nguyen, SN; Ruegger, MC; Salazar, E, 2021
)
1.05
" Only 37% of patients on warfarin had optimal dosing control, and they did not differ significantly in TTB, TTT, and OS from patients on DOACs."( Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.
Atić, A; Hadžibegović, I; Hulak Karlak, V; Jurin, I; Lucijanić, M; Magličić, A; Šakić, Z; Starčević, B, 2020
)
0.56
" Patients receiving warfarin rarely obtain optimal dosing control, and experience significantly shorter survival compared with patients receiving DOACs."( Patterns of anticoagulation therapy in atrial fibrillation: results from a large real-life single-center registry.
Atić, A; Hadžibegović, I; Hulak Karlak, V; Jurin, I; Lucijanić, M; Magličić, A; Šakić, Z; Starčević, B, 2020
)
0.56
"The direct oral anticoagulants (DOAC) have similar half-lives, but the dosing regimen varies between once daily (QD) or twice daily (BID)."( Twice- or Once-Daily Dosing of Direct Oral Anticoagulants, a systematic review and meta-analysis.
Bertoletti, L; Cucherat, M; Durieu, I; Grange, C; Grenet, G; Gueyffier, F; Kilo, R; Laporte, S; Lega, JC; Mainbourg, S; Mismetti, P; Nony, P; Provencher, S, 2021
)
0.62
"Direct oral anticoagulant (DOAC) starter packs are designed for unique treatment dosing for acute venous thromboembolism (VTE)."( Adverse outcomes associated with inappropriate direct oral anticoagulant starter pack prescription among patients with atrial fibrillation: a retrospective claims-based study.
Barnes, GD; Feng, Y; Pai, CW; Seiler, K, 2021
)
0.62
" Further research is needed to determine the impact of ALM on bleeding complications and the potential role of ALM-guided dosing for sarcopenic patients."( Muscle Mass and Direct Oral Anticoagulant Activity in Older Adults With Atrial Fibrillation.
Afilalo, J; Afilalo, M; Bendayan, M; Blostein, M; Chen-Tournoux, A; Eintracht, S; MacNamara, E; Mardigyan, V; Rudski, L; Williamson, D, 2021
)
0.62
" In this study, we examined sex differences as a post hoc analysis of RELAXED (Recurrent Embolism Lessened by rivaroxaban, an anti-X agent, of Early Dosing for acute IS and TIA with atrial fibrillation) Study."( Sex Differences in Management and Outcomes of Cardioembolic Stroke: Post HOC Analyses of the RELAXED Study.
Hamasaki, T; Hirano, T; Kageyama, H; Minematsu, K; Mori, E; Nagao, T; Okada, T; Sakakibara, F; Toyoda, K; Uchida, K; Uchiyama, S; Yamagami, H; Yasaka, M; Yoshimura, S, 2021
)
0.83
"Observational studies assessing direct oral anticoagulant (DOACs) dosage in atrial fibrillation (AF) reported that a lower proportion of patients received high-dose DOACs compared to those in randomized controlled trials (RCTs)."( Comparative effectiveness and safety of high-dose rivaroxaban and apixaban for atrial fibrillation: A propensity score-matched cohort study.
Brophy, JM; Côté, R; de Denus, S; Dorais, M; Dragomir, A; Dubé, MP; Lenglet, A; Perreault, S; Schnitzer, ME; Tardif, JC; White-Guay, B, 2021
)
0.87
"The clinical use of factor VIII inhibitor bypassing activity (FEIBA) for factor Xa (FXa) inhibitor reversal is derived from small studies with notable variation in patient eligibility for use, dosage regimens, concurrent supportive care, and outcome measures."( Factor VIII Inhibitor Bypassing Activity (FEIBA) Reversal for Apixaban and Rivaroxaban in Patients With Acute Intracranial and Nonintracranial Hemorrhage.
Coffeen, SN; Hunt, AR; Ice, C; Parker, J; Shiltz, DL, 2021
)
0.85
"To clarify the appropriate initial dosage of heparin during radiofrequency catheter ablation (RFCA) in patients with atrial fibrillation (AF) receiving uninterrupted nonvitamin K antagonist oral anticoagulant (NOAC) treatment."( Appropriate intraprocedural initial heparin dosing in patients undergoing catheter ablation for atrial fibrillation receiving uninterrupted non-vitamin-K antagonist oral anticoagulant treatment.
Dong, YX; Gao, LJ; Li, WW; Ma, CM; Wang, N; Xia, YL; Xiao, XJ; Yang, MH; Yin, XM; Yu, XH; Zhang, RF, 2021
)
0.62
"For patients with AF receiving uninterrupted NOAC treatment who underwent RFCA, an initial heparin dosage of 120 U/kg or 130 U/kg can provide an adequate intraprocedural anticoagulant effect, and 130 U/kg allowed ACT to reach the target earlier."( Appropriate intraprocedural initial heparin dosing in patients undergoing catheter ablation for atrial fibrillation receiving uninterrupted non-vitamin-K antagonist oral anticoagulant treatment.
Dong, YX; Gao, LJ; Li, WW; Ma, CM; Wang, N; Xia, YL; Xiao, XJ; Yang, MH; Yin, XM; Yu, XH; Zhang, RF, 2021
)
0.62
" These differences between DOACs with almost equal half-life are probably partly due to the differences in dosing interval: twice a day (BID) versus once a day (QD)."( [Is one DOAC better than another?]
Pos, L, 2021
)
0.62
" However, suboptimal adherence, variable dosing and use in patient populations that otherwise would have been excluded from clinical trials may impact the efficacy and safety profile of DOACs in a routine care setting."( Dose specific effectiveness and safety of DOACs in patients with non-valvular atrial fibrillation: A Canadian retrospective cohort study.
Dasgupta, K; Godin, R; Nedjar, H; Rahme, E; Tagalakis, V, 2021
)
0.62
" This study aimed to explore appropriate remedial dosing regimens for non-adherent rivaroxaban-treated patients."( How to handle the delayed or missed dose of rivaroxaban in patients with non-valvular atrial fibrillation: model-informed remedial dosing.
Jiao, Z; Li, ZR; Liu, XQ; Wang, CY; Yin, YW; Zhu, X, 2021
)
1.11
"Monte Carlo simulation based on a previously established rivaroxaban population pharmacokinetic/pharmacodynamic (PK/PD) model for patients with NVAF was employed to design remedial dosing regimens."( How to handle the delayed or missed dose of rivaroxaban in patients with non-valvular atrial fibrillation: model-informed remedial dosing.
Jiao, Z; Li, ZR; Liu, XQ; Wang, CY; Yin, YW; Zhu, X, 2021
)
1.13
"The proposed remedial dosing regimens were dependent on delay duration."( How to handle the delayed or missed dose of rivaroxaban in patients with non-valvular atrial fibrillation: model-informed remedial dosing.
Jiao, Z; Li, ZR; Liu, XQ; Wang, CY; Yin, YW; Zhu, X, 2021
)
0.88
"PK/PD modeling and simulation provide valid evidence on the remedial dosing regimen of rivaroxaban, which could help to minimize the risk of bleeding and thromboembolism."( How to handle the delayed or missed dose of rivaroxaban in patients with non-valvular atrial fibrillation: model-informed remedial dosing.
Jiao, Z; Li, ZR; Liu, XQ; Wang, CY; Yin, YW; Zhu, X, 2021
)
1.11
" US Food and Drug Administration-approved dosing was used in 91."( Evaluation of Prescribing Practices and Outcomes Using Direct-acting Oral Anticoagulants After Cardiac Surgery.
Cook, BM; Kanaan, DM; Kelly, J; Malloy, R, 2021
)
0.62
"In the XAPASS, a large-scale study involving a broad range of patients with non-valvular atrial fibrillation newly prescribed rivaroxaban using Japan-specific dosage in real-world clinical practice, no unexpected safety or effectiveness concerns were detected during up to 5 years of follow-up."( Real-world safety and effectiveness of rivaroxaban using Japan-specific dosage during long-term follow-up in patients with atrial fibrillation: XAPASS.
Hayasaki, T; Hirano, K; Ikeda, T; Iwashiro, S; Kitazono, T; Minematsu, K; Miyamoto, S; Murakawa, Y; Nakagawara, J; Ogawa, S; Okayama, Y; Sunaya, T, 2021
)
1.1
"All randomized controlled trials (RCTs) comparing LD DOAC (defined as a dosage below the lowest approved for stroke prevention) vs placebo among patients with CVD receiving single or dual antiplatelet therapy (DAPT) in at least 50% of the population and followed for at least 6 months, were included."( Efficacy and safety of dual-pathway inhibition in patients with cardiovascular disease: a meta-analysis of 49 802 patients from 7 randomized trials.
Andreotti, F; Angiolillo, DJ; Benenati, S; Capodanno, D; Crea, F; D'Amario, D; Galli, M, 2022
)
0.72
"We aimed to assess differences in ACT values and UFH dosage during PVI in patients on different oral anticoagulants."( Differences in activated clotting time and total unfractionated heparin dose during pulmonary vein isolation in patients on different anticoagulation therapy.
Anic, A; Bakotic, Z; Benko, I; Bojko, A; Brusich, S; Jan, M; Manola, S; Pavlovic, N; Pernat, A; Pezo Nikolic, B; Radeljic, V; Scherr, D; Szavits Nossan, J; Traykov, V; Velagic, V; Zeljkovic, I, 2021
)
0.62
" The iterative and integrative use of PBPK and PopPK modeling and simulation played a major role in the establishment of the bodyweight-adjusted rivaroxaban dosing regimen that was ultimately confirmed to be a safe and efficacious dosing regimen for children aged 0 to 18 years with acute VTE in the EINSTEIN-Jr phase III study."( Population pharmacokinetic analysis of rivaroxaban in children and comparison to prospective physiologically-based pharmacokinetic predictions.
Coboeken, K; Drenth, HJ; Ince, I; Kubitza, D; Lensing, AWA; Lippert, J; Mayer, H; Mesic, E; Mück, W; Thelen, K; Willmann, S; Yang, H; Zhang, Y; Zhu, P, 2021
)
1.09
" There is a paucity of data for rates of inappropriate inpatient DOAC dosing in Australia."( Appropriateness of inpatient dosing of direct oral anticoagulants for atrial fibrillation.
Caughey, GE; Li, RJ; Shakib, S, 2022
)
0.72
" Results of clinical trials and real clinical practice studies have confirmed that rivaroxaban may provide a comprehensive protection for a senile patient with AF due to favorable indexes of efficiency and safety, beneficial effect on the risk of coronary events and impairment оf renal function, whereas once a day dosing of rivaroxaban improves the compliance with this treatment and its constancy."( [Atrial fibrillation in old age: risk management and features of the use of direct oral anticoagulants].
Kanorskii, SG, 2021
)
0.85
"To analyse the appropriateness of direct oral anticoagulant (DOAC) dosing and determinants for under-and overdosing as well as acceptance and implementation rates of pharmacists' interventions."( Determinants for under- and overdosing of direct oral anticoagulants and physicians' implementation of clinical pharmacists' recommendations.
Cornu, P; Dupont, A; Moudallel, S; Steurbaut, S, 2022
)
0.72
" However, there is much debate regarding the best dosage regimen, and there is no consensus on the role of extended thromboprophylaxis."( Medically Ill hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis with rivaroxaban ThErapy: Rationale and Design of the MICHELLE Trial.
Agati, LB; Aguiar, VCR; Calderaro, D; Cavalcante, BBM; Chate, RC; Chiann, C; Cortina, AS; de Moraes, NF; de Oliveira, ALML; de Oliveira, CCC; Dedivitis, RA; Dusilek, C; Itinose, K; Joviliano, EE; Lopes, RD; Moreira, RCR; Ramacciotti, E; Rodrigues, E; Sanches, SMV; Santos, MVB; Sobreira, ML; Spyropoulos, AC; Tachibana, A; Tafur, A; Tierno, PFGMM; Volpiani, GG, 2021
)
0.84
" In patients aged 80 years and over, however, the fear of DOAC-associated bleeding and the complexity of DOAC dosing regimes may prompt physicians to prescribe inappropriate dose levels."( Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.
Cavillon Decaestecker, M; Decaestecker, K; Ferret, L; Gautier, S; Tsogli, ES; Verdun, S, 2021
)
0.62
" In contrast, initial management in a neurology department was associated with appropriate dosing (p = 0."( Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.
Cavillon Decaestecker, M; Decaestecker, K; Ferret, L; Gautier, S; Tsogli, ES; Verdun, S, 2021
)
0.62
" It might be possible to reduce inappropriate dosing by raising awareness among hospital-based and private-practice prescribers, providing prescription support tools for DOACs, and performing medication reconciliations and reviews at hospital and in private practice."( Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over.
Cavillon Decaestecker, M; Decaestecker, K; Ferret, L; Gautier, S; Tsogli, ES; Verdun, S, 2021
)
0.62
" A physiologically based pharmacokinetic rivaroxaban model was used to predict a pediatric dosing regimen that would produce drug exposures similar to that of 10 mg once daily in adults."( Dosing Regimen Prediction and Confirmation With Rivaroxaban for Thromboprophylaxis in Children After the Fontan Procedure: Insights From the Phase III UNIVERSE Study.
Harris, KC; Kubitza, D; Lesko, LJ; Li, JS; McCrindle, BW; Michelson, AD; Nessel, K; Pina, LM; Weber, T; Willmann, S; Yang, H; Zannikos, P; Zhou, W; Zhu, P, 2022
)
1.24
"Ciraparantag provides a dose-related reversal of anticoagulation induced by steady-state dosing of apixaban or rivaroxaban."( Ciraparantag reverses the anticoagulant activity of apixaban and rivaroxaban in healthy elderly subjects.
Ansell, J; Bakhru, S; Freedman, D; Laulicht, BE; Tracey, G; Villano, S, 2022
)
1.17
" The UNIVERSE Study evaluated the efficacy and safety of a novel liquid rivaroxaban formulation, using a body weight-adjusted dosing regimen, versus acetylsalicylic acid (ASA) in children post-Fontan."( Thromboprophylaxis for Children Post-Fontan Procedure: Insights From the UNIVERSE Study.
Harris, KC; Jefferies, JL; Justino, H; Li, JS; Lu, W; McCrindle, BW; Michelson, AD; Miriam Pina, L; Nessel, K; Pablo Sandoval, J; Peluso, C; Suzana Horowitz, E; Van Bergen, AH, 2021
)
0.85
" To what extent the observed increases in DOAC exposure in the older patients is the cause of their increased risk of bleeding, which could potentially be ameliorated by dosing titration, requires further investigation."( Assessment of exposure to direct oral anticoagulants in elderly hospitalised patients.
Avery, P; Biss, T; Kamali, F; Kampouraki, E; Wynne, H, 2021
)
0.62
" Previous VKA dosage and creatinine clearance were inversely associated with DOAC trough concentrations."( Inter- and intra-individual concentrations of direct oral anticoagulants: The KIDOAC study.
Cannegieter, SC; Huisman, MV; Lijfering, WM; Nierman, MC; Toorop, MMA; van der Meer, FJM; van Rein, N; Vermaas, HW, 2022
)
0.72
" Lower previous VKA dosage and creatinine clearance were associated with higher DOAC trough concentrations."( Inter- and intra-individual concentrations of direct oral anticoagulants: The KIDOAC study.
Cannegieter, SC; Huisman, MV; Lijfering, WM; Nierman, MC; Toorop, MMA; van der Meer, FJM; van Rein, N; Vermaas, HW, 2022
)
0.72
" In these situations, the type, dosage or the time of last intake of anticoagulants is often unknown and single substance analysis by functional tests is only possible if the substance contained in the sample is known."( Development and validation of an analytical method for the determination of direct oral anticoagulants (DOAC) and the direct thrombin-inhibitor argatroban by HPLC-MS/MS.
Beyer-Westendorf, J; Brückner, L; Pietsch, J; Tiebel, O, 2022
)
0.72
"Clear guidelines exist to guide the dosing of direct-acting oral anticoagulants (DOACs)."( Guideline-discordant dosing of direct-acting oral anticoagulants in the veterans health administration.
Berlowitz, DR; Lee, JS; Liu, W; Mitra, A; Rose, AJ; Yu, H, 2021
)
0.62
" We examined how often patient dosing was concordant with these recommendations."( Guideline-discordant dosing of direct-acting oral anticoagulants in the veterans health administration.
Berlowitz, DR; Lee, JS; Liu, W; Mitra, A; Rose, AJ; Yu, H, 2021
)
0.62
"A substantial portion of DOAC prescriptions in the VA system are dosed contrary to clinical guidelines."( Guideline-discordant dosing of direct-acting oral anticoagulants in the veterans health administration.
Berlowitz, DR; Lee, JS; Liu, W; Mitra, A; Rose, AJ; Yu, H, 2021
)
0.62
" The secondary outcome evaluated patients who reported time of last known DOAC dose within a preferred time frame of <12 h for once daily dosing DOAC therapy or < 6 h for twice daily dosing DOAC therapy."( Evaluation of direct oral anticoagulant use on thromboelastography in an emergency department population.
Jenrette, J; Ray, L; Schwarz, K; Trujillo, T, 2022
)
0.72
" Child-appropriate formulations have been developed, age-specific dosing information generated, and safety and efficacy evaluated in ongoing phase 3 trials."( Anticoagulation in Pediatric Patients.
Male, C, 2022
)
0.72
" Therefore, the convenience of dosing may be essential."( [Atrial fibrillation and cognitive impairment: features of the relationship, developmental and prevention mechanisms].
Kovaleva, AY; Lifshits, GI; Lukinov, VL, 2022
)
0.72
" The established population PK-PD model could inform individualized dosing for Chinese NVAF patients who are administered rivaroxaban."( Population pharmacokinetic and pharmacodynamic analysis of rivaroxaban in Chinese patients with non-valvular atrial fibrillation.
Ding, HY; Jiao, Z; Liu, XQ; Ma, CL; Yan, MM; Zhang, YF; Zhong, MK, 2022
)
1.17
" However, because of the National Health Insurance regulations, available dosage forms, and clinical conditions, the prescribed dose of rivaroxaban may not be consistent with its recommended dose."( Effectiveness and Safety of Lower Dose of Rivaroxaban for Cancer-Related Venous Thromboembolism: A Retrospective Cohort Study.
Chang, CL; Kuo, CN; Lin, YJ; Pan, CC, 2022
)
1.19
" This result may be applied to the institutions with dosage availability limited by formulary regulation and patients who cannot use full dose because of clinical considerations."( Effectiveness and Safety of Lower Dose of Rivaroxaban for Cancer-Related Venous Thromboembolism: A Retrospective Cohort Study.
Chang, CL; Kuo, CN; Lin, YJ; Pan, CC, 2022
)
0.99
" The use of PCC and dosage administered is inconsistent."( Real-world decision-making in the management of patients presenting with major bleeding on rivaroxaban: the Auckland regional experience.
Eaddy, N; Grainger, BT; Merriman, E; Ockelford, P; Royle, G; Young, L, 2023
)
1.13
"Although predictable pharmacokinetic and pharmacodynamic of rivaroxaban allow fixed dosing regimens without routine coagulation monitoring, there is still the necessity to monitor and predict the effects of rivaroxaban in specific conditions and different populations."( Rivaroxaban population pharmacokinetic and pharmacodynamic modeling in Iranian patients.
Abdar Esfahani, M; Davoudian, A; Esmaeili, T; Omidfar, D; Rezaee, M; Rezaee, S, 2022
)
2.41
" Peak and trough drug plasma concentrations were collected based on the dosing interval and pharmacokinetics of the drugs and quantified using high performance liquid chromatography."( Simvastatin, but Not Atorvastatin, Is Associated with Higher Peak Rivaroxaban Serum Levels and Bleeding: an Asian Cohort Study from Singapore.
Chan, ECY; Soh, XQ; Tan, DS, 2023
)
1.15
" As the overall effect of accumulation of several covariates could be difficult to apprehend for the clinicians, PopPK modeling could represent an interesting approach for informed precision dosing and to improve personalized prescription of DOACs."( Population Pharmacokinetic Models for Direct Oral Anticoagulants: A Systematic Review and Clinical Appraisal Using Exposure Simulation.
Csajka, C; Daali, Y; Fontana, P; Gaspar, F; Guidi, M; Reny, JL; Terrier, J, 2022
)
0.72
" Herein, we first conducted a meta-analysis to separately assess the effects of off-label underdosing versus on-label dosing of four individual NOACs on adverse outcomes in the AF population."( Off-label underdosing of four individual NOACs in patients with nonvalvular atrial fibrillation: A systematic review and meta-analysis of observational studies.
Chen, J; Lai, Y; Liu, X; Sang, C; Sun, J; Zhu, W, 2022
)
0.72
" When comparing off-label underdosing versus on-label dosing of dabigatran or edoxaban, no differences were found in the primary and secondary clinical outcomes."( Off-label underdosing of four individual NOACs in patients with nonvalvular atrial fibrillation: A systematic review and meta-analysis of observational studies.
Chen, J; Lai, Y; Liu, X; Sang, C; Sun, J; Zhu, W, 2022
)
0.72
"To investigate effects of appropriately and inappropriately dosed apixaban/rivaroxaban versus warfarin on effectiveness and safety outcomes in patients with non-valvular atrial fibrillation (NVAF)."( Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case-control analyses from UK primary care.
Brobert, G; Fatoba, S; García Rodríguez, LA; González-Pérez, A; Roberts, L; Saez, ME; Vora, P, 2022
)
1.19
" Using logistic regression, adjusted ORs with 95% CIs were calculated for the outcomes comparing apixaban/rivaroxaban use (appropriate or inappropriate dosing based on the product label criteria) and warfarin."( Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case-control analyses from UK primary care.
Brobert, G; Fatoba, S; García Rodríguez, LA; González-Pérez, A; Roberts, L; Saez, ME; Vora, P, 2022
)
1.17
" They should, therefore, be interpreted with caution, and prescribers should adhere to the dosing instructions in the respective Summary of Product Characteristics."( Safety and effectiveness of appropriately and inappropriately dosed rivaroxaban or apixaban versus warfarin in patients with atrial fibrillation: a cohort study with nested case-control analyses from UK primary care.
Brobert, G; Fatoba, S; García Rodríguez, LA; González-Pérez, A; Roberts, L; Saez, ME; Vora, P, 2022
)
0.96
" We sought to determine how well dosing recommended in the rivaroxaban drug label results in exposure for real-world patients within a reference area under the concentration-time curve (AUC) range."( Leveraging a Previously Published Population Pharmacokinetic Model to Predict Rivaroxaban Exposure in Real-World Patients.
Campbell, KB; Gehi, A; Gonzalez, D; Kashuba, ADM; Konicki, R; Moll, S; Patterson, JH; Powell, JR; Qaraghuli, FA; Tyson, R; Weiner, D, 2022
)
1.19
" Optimal dosing and timing of these treatments and benefits of other antithrombotic agents remain unclear."( ISTH guidelines for antithrombotic treatment in COVID-19.
Bradbury, CA; Broxmeyer, L; Connors, JM; Falanga, A; Iba, T; Kaatz, S; Levy, JH; Middeldorp, S; Minichiello, T; Ramacciotti, E; Resnick, HE; Samama, CM; Schulman, S; Sholzberg, M; Spyropoulos, AC; Thachil, J; Zarychanski, R, 2022
)
0.72
" Reduced apixaban and rivaroxaban dosing regimens are recommended when dronedarone is co-administered to patients with AF."( Predicting drug-drug interactions with physiologically based pharmacokinetic/pharmacodynamic modelling and optimal dosing of apixaban and rivaroxaban with dronedarone co-administration.
He, QF; Jiao, Z; Wen, HN; Xiang, XQ; Yu, JG, 2022
)
1.24
" A total daily dosage of 15 mg was given to 23% of the patients."( A retrospective study of real-world effectiveness and safety of rivaroxaban in patients with non-valvular atrial fibrillation and venous thromboembolism in Saudi Arabia.
Albackr, H; Algahtani, FH; Alharbi, AA; Alhossan, A; Alosaimi, HM; Alqahtani, M; Alqahtani, NA; Alqahtani, S; Alqahtany, FS; Alzamil, F; Balkhi, B; Elgohary, G, 2022
)
0.96
" The dosage and duration of FXa inhibitor therapy also differ."( Anti-factor Xa activity, prothrombin time, and activated partial thromboplastin time in patients treated with factor Xa inhibitors.
Fukushima, K; Hori, Y; Kobayashi, Y; Nishimura, K; Ono, R; Takahashi, H, 2023
)
0.91
" However, there remain gaps in our understanding of dosage and disparities in use."( Trends in direct oral anticoagulant (DOAC) prescribing in English primary care (2014-2019).
Arora, J; de Lusignan, S; Delanerolle, G; Emanuel, S; Fan, X; Feher, M; Field, BC; Heiss, C; Hobbs, FR; Joy, M; Kar, D; Pollock, KG; Sandler, B; Sheppard, JP; Williams, J, 2023
)
0.91
"The potential effects of glucocorticoid administration on rivaroxaban's anticoagulant bioactivity in dogs, and an appropriate rivaroxaban dosage regimen for dogs receiving glucocorticoid therapy are unknown."( Anticoagulant effects of rivaroxaban, prednisone, alone and in combination, in healthy dogs.
Brooks, MB; Hafner, PM; Mackin, AJ; Thomason, JM; Wills, RW, 2022
)
1.27
" Prednisone administration had no apparent influence on the anticoagulant effects of rivaroxaban in healthy dogs, suggesting that combined therapy will not require dosage adjustments."( Anticoagulant effects of rivaroxaban, prednisone, alone and in combination, in healthy dogs.
Brooks, MB; Hafner, PM; Mackin, AJ; Thomason, JM; Wills, RW, 2022
)
1.25
"Per-label dosing of direct oral anticoagulants (DOACs) is important for the prevention of stroke and systemic embolism among patients with non-valvular atrial fibrillation (NVAF), especially those with poor renal function, advanced age, low body weight or concomitant P-glycoprotein inhibitors."( Direct Oral Anticoagulant (DOAC) Dosing in Patients with Non-valvular Atrial Fibrillation (NVAF) in the United Kingdom: A Retrospective Cohort Study Using CPRD Gold Database.
Anastassopoulou, A; Doobaree, IU; Fay, M; Gusto, G; Khachatryan, A; Manu, M; Mughal, F; Spentzouris, G; Zawaneh, Y, 2023
)
0.91
"Although most patients received per-label dosing, ~ one in five patients was incorrectly dosed with DOAC, which may lead to serious clinical consequences and increased healthcare burden."( Direct Oral Anticoagulant (DOAC) Dosing in Patients with Non-valvular Atrial Fibrillation (NVAF) in the United Kingdom: A Retrospective Cohort Study Using CPRD Gold Database.
Anastassopoulou, A; Doobaree, IU; Fay, M; Gusto, G; Khachatryan, A; Manu, M; Mughal, F; Spentzouris, G; Zawaneh, Y, 2023
)
0.91
" The neutralization of various FXa inhibitors was dose and donor-dependent warranting dosage adjustment for optimal outcomes."( Differential Neutralization of Apixaban, Betrixaban, Edoxaban, and Rivaroxaban by Andexanet Alfa as Measured by Whole Blood Thromboelastographic Analysis.
Fareed, J; Hoppensteadt, D; Iqbal, O; Jaradeh, M; Jeske, W; Kantarcioglu, B; Lewis, B; Mehrotra, S; Siddiqui, F; Tafur, A,
)
0.37
" Hypothetically, an increased glomerular filtration rate (GFR) may lead to suboptimal dosing and a higher thromboembolic events incidence."( Impact of increased kidney function on clinical and biological outcomes in real-world patients treated with Direct Oral Anticoagulants.
Acosta-Isaac, R; Corrochano, M; Mojal, S; Moret, C; Muñoz, R; Plaza, M; Souto, JC, 2022
)
0.72
" Importantly, no study has adequately accounted for warfarin dosing being continuously modified based on INR values while dosing of DOACs is fixed."( Comparison of medication adherence to different oral anticoagulants: population-based cohort study.
Ágústsson, AS; Björnsson, ES; Guðmundsdóttir, BR; Hreinsson, JP; Ingason, AB; Lund, SH; Önundarson, PT; Pálsson, DA; Reynisson, IE; Rumba, E, 2023
)
0.91
" Additional data on safety, efficacy, and dosing strategies for reversal agents are also necessary, especially as the use of DOACs becomes more common in the pediatric population."( Just DOAC: Use of direct-acting oral anticoagulants in pediatrics.
Cober, MP; Fenn, NE; Hill, C; King, M; Mills, K; Omecene, NE; Pauley, JL; Sierra, CM; Smith, T, 2023
)
0.91
" Our simulation results revealed that recommended reduced dosing regimen of dabigatran etexilate during comedication with verapamil and clarithromycin (110 and 75 mg BID for Chinese young and old older adults) will result in exposure (trough concentration) that was either slightly higher or similar to the trough concentration of patients with any bleeding events."( Physiologically-based pharmacokinetic modeling to predict drug-drug interactions of dabigatran etexilate and rivaroxaban in the Chinese older adults.
Cui, C; Lai, X; Li, H; Liu, D; Sia, JEV; Wu, X; Zhang, F, 2023
)
1.12
" Model verification was performed for intravenous and oral (single and multiple) dosing regimens."( Development and verification of a physiologically based pharmacokinetic model of dronedarone and its active metabolite N-desbutyldronedarone: Application to prospective simulation of complex drug-drug interaction with rivaroxaban.
Ang, XJ; Chan, ECY; Leow, JWH, 2023
)
1.1
"Dronedarone and NDBD PK following clinically relevant doses of 400 mg dronedarone across single and multiple oral dosing were accurately simulated by incorporating effect of auto-inactivation on dose nonlinearities."( Development and verification of a physiologically based pharmacokinetic model of dronedarone and its active metabolite N-desbutyldronedarone: Application to prospective simulation of complex drug-drug interaction with rivaroxaban.
Ang, XJ; Chan, ECY; Leow, JWH, 2023
)
1.1
" Nevertheless, high interindividual variability in DOAC exposure in older adults was noted, which can be explained by distinctive older patient characteristics, such as kidney function, changes in body composition (especially reduced muscle mass), and co-medication with P-gp inhibitors, which is in line with the current dosing reduction criteria of apixaban, edoxaban, and rivaroxaban."( Insights into the Pharmacokinetics and Pharmacodynamics of Direct Oral Anticoagulants in Older Adults with Atrial Fibrillation: A Structured Narrative Review.
Dia, N; Dreesen, E; Edwina, AE; Spriet, I; Tournoy, J; Van der Linden, L; Vanassche, T; Verhamme, P, 2023
)
1.08
" Dosing was considered inappropriate when use of eGFR resulted in a lower (undertreatment) or higher (overtreatment) dose than that recommended by the eCrCl."( Variability in Nonvitamin K Oral Anticoagulant Dose Eligibility and Adjustment According to Renal Formulae and Clinical Outcomes in Patients With Atrial Fibrillation With and Without Chronic Kidney Disease: Insights From ORBIT-AF II.
Andrade, JG; Fordyce, CB; Holmes, DN; Levin, A; Piccini, JP; Yao, RJR, 2023
)
0.91
" The dose-response curve of rivaroxaban was satisfactory based on the peak and trough plasma levels and all concentrations were in the recommended treatment range according to NOAC guidelines."( An exploratory study of effectiveness and safety of rivaroxaban in patients with left ventricular thrombus (R-DISSOLVE).
Feng, G; Liang, Y; Quan, X; Wang, C; Yang, Q; Yang, Y; Yu, D; Yu, L; Zhang, T; Zhang, Y; Zhu, J, 2023
)
1.45
"Twice-daily dosing of non-vitamin K antagonist oral anticoagulants (NOACs) may reduce drug adherence compared with once-daily dosing of NOACs in patients with atrial fibrillation (AF), thus worsening clinical outcomes."( Adherence and clinical outcomes for twice-daily versus once-daily dosing of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Is dosing frequency important?
Bae, YJ; Hwang, HJ; Jin, ES; Sohn, IS, 2023
)
0.91
" The proportion of patients with high adherence to NOACs was 95%, which did not significantly differ according to the dosing regimen."( Adherence and clinical outcomes for twice-daily versus once-daily dosing of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Is dosing frequency important?
Bae, YJ; Hwang, HJ; Jin, ES; Sohn, IS, 2023
)
0.91
"Adherence between once- and twice-daily dosing NOACs in patients with AF was high and similar among both dosing regimens."( Adherence and clinical outcomes for twice-daily versus once-daily dosing of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation: Is dosing frequency important?
Bae, YJ; Hwang, HJ; Jin, ES; Sohn, IS, 2023
)
0.91
" DOAC dosing in the acutely ill patient could impose an even greater challenge."( Inappropriate prescriptions of direct oral anticoagulants (DOACs) in hospitalized patients: A narrative review.
Huisman, MV; Klok, FA; van der Horst, SFB; van Mens, TE; van Rein, N, 2023
)
0.91
"Dabigatran is the first of four direct-acting oral anticoagulants approved to prevent stroke in adult patients with atrial fibrillation using a fixed two-dose scheme compared with warfarin dosing adjusted to a prothrombin time range associated with optimal risk reduction in stroke and serious bleeding."( Dabigatran Dosing Proposal for Adults With Atrial Fibrillation: Stress-Testing Renal Function Range in Real World Patients.
Al Qaraghuli, F; Fiedler-Kelly, J; Gonzalez, D; Powell, JR; Weiner, D, 2023
)
0.91
"26)), once daily DOAC dosing (OR = 3."( Impact of Direct Oral Anticoagulant Concentration on Clinical Outcomes in Asian Patients with Atrial Fibrillation.
Ho, LT; Huang, CF; Jeng, JS; Kuo, CH; Lin, SY; Liu, YB; Peng, YF; Tang, SC; Tsai, LK, 2023
)
0.91
" The objectives of this study were to evaluate DOAC dosing discordance and to determine whether discordance based on various estimates of kidney function is associated with bleeding or thromboembolism."( DOAC Dosing Discordance Using Different Estimates of Kidney Function and Outcomes.
Achanta, A; Bhalodia, NJ; Cheng, J; Coons, JC; Deri, CR; Heiney, H; Iasella, CJ; Marchionda, O; Stahl, K; White, EM, 2023
)
0.91
" Accordingly, a physiologically-based pharmacokinetic (PBPK) analysis was performed to predict the magnitude of DDI on apixaban and rivaroxaban exposures in the presence of 160 mg once-daily dosing of enzalutamide."( Physiologically-based pharmacokinetic modeling to predict drug-drug interaction of enzalutamide with combined P-gp and CYP3A substrates.
Bonate, PL; Jamei, M; Minematsu, T; Otsuka, Y; Poondru, S; Rose, RH; Ushigome, F, 2023
)
1.11
"Lower risks for bleed and mortality associated with reduced- versus standard-dose dabigatran in patients with AF and a high bleeding risk suggest a better dosing strategy."( Effectiveness and safety of Dabigatran 110 mg versus 150 mg for Stroke Prevention in Patients with Atrial Fibrillation at High Bleeding Risk.
An, J; Cheetham, TC; Lang, DT; Lee, MS; Luong, T; Reynolds, K, 2023
)
0.91
"Possible challenges in dosing non-vitamin K antagonist oral anticoagulants in nonvalvular atrial fibrillation (NVAF) and limited evidence in Saudi Arabia make it difficult to assess their appropriateness."( Appropriateness of rivaroxaban and apixaban dosing in hospitalized patients with a newly diagnosed nonvalvular atrial fibrillation at a single tertiary hospital.
Alshibani, M, 2023
)
1.24
"Limited real-world data show that rivaroxaban following dosage criteria from either ROCKET AF [20 mg/day or 15 mg/day if creatinine clearance (CrCl) < 50 mL/min] or J-ROCKET AF (15 mg/day or 10 mg/day if CrCl < 50 mL/min) is associated with comparable risks of thromboembolism and bleeding with each other in patients with non-valvular atrial fibrillation (NVAF)."( Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies.
Chan, CY; Chan, YH; Chao, TF; Chen, SW; Lip, GYH, 2023
)
1.38
" Effectiveness and safety endpoints were compared between ROCKET AF and J-ROCKET AF dosing regimen in Asian and non-Asian subjects, separately."( Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies.
Chan, CY; Chan, YH; Chao, TF; Chen, SW; Lip, GYH, 2023
)
1.1
"Rivaroxaban dosing regimen following J-ROCKET criteria may serve as an alternative to ROCKET AF criteria for the Asian population with NVAF, whereas the dosing regimen following ROCKET AF criteria was more favourable for the non-Asian population."( Comparisons of effectiveness and safety between on-label dosing, off-label underdosing, and off-label overdosing in Asian and non-Asian atrial fibrillation patients treated with rivaroxaban: a systematic review and meta-analysis of observational studies.
Chan, CY; Chan, YH; Chao, TF; Chen, SW; Lip, GYH, 2023
)
2.55
" Inappropriate dosing was noted in 18% of the population."( Characteristics of patients with atrial fibrillation treated with direct oral anticoagulants and new insights into inappropriate dosing: results from the French National Prospective Registry: PAFF.
Assouline, S; Cohen, C; Cohen, S; Dhanjal, TS; Dib, JC; Dievart, F; Durand, P; Garban, T; Guedj-Meynier, D; Guenoun, M; Hoffman, O; Lellouche, N; Lequeux, B; Ouazana, L; Parrens, E; Pradeau, V; Sabouret, P; Schwartz, J; Sharareh, A; Villaceque, M, 2023
)
0.91
"Within this large registry, DOACs were associated with inappropriate dosing in 18% of cases."( Characteristics of patients with atrial fibrillation treated with direct oral anticoagulants and new insights into inappropriate dosing: results from the French National Prospective Registry: PAFF.
Assouline, S; Cohen, C; Cohen, S; Dhanjal, TS; Dib, JC; Dievart, F; Durand, P; Garban, T; Guedj-Meynier, D; Guenoun, M; Hoffman, O; Lellouche, N; Lequeux, B; Ouazana, L; Parrens, E; Pradeau, V; Sabouret, P; Schwartz, J; Sharareh, A; Villaceque, M, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
anticoagulantAn agent that prevents blood clotting.
EC 3.4.21.6 (coagulation factor Xa) inhibitorAn EC 3.4.21.* (serine endopeptidase) inhibitor that interferes with the action of coagulation factor Xa (EC 3.4.21.6).
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (7)

ClassDescription
thiophenesCompounds containing at least one thiophene ring.
organochlorine compoundAn organochlorine compound is a compound containing at least one carbon-chlorine bond.
oxazolidinoneAn oxazolidine containing one or more oxo groups.
morpholinesAny compound containing morpholine as part of its structure.
lactamCyclic amides of amino carboxylic acids, having a 1-azacycloalkan-2-one structure, or analogues having unsaturation or heteroatoms replacing one or more carbon atoms of the ring.
aromatic amideAn amide in which the amide linkage is bonded directly to an aromatic system.
monocarboxylic acid amideA carboxamide derived from a monocarboxylic acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (9)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Activated Factor Xa Heavy ChainHomo sapiens (human)Ki0.00040.00040.00040.0004AID977610
ATP-binding cassette sub-family C member 3Homo sapiens (human)IC50 (µMol)133.00000.63154.45319.3000AID1473740
Multidrug resistance-associated protein 4Homo sapiens (human)IC50 (µMol)133.00000.20005.677410.0000AID1473741
Bile salt export pumpHomo sapiens (human)IC50 (µMol)133.00000.11007.190310.0000AID1473738
ProthrombinHomo sapiens (human)Ki1.00000.00000.78469.0000AID1057658
Coagulation factor XHomo sapiens (human)IC50 (µMol)0.00380.00030.593710.0000AID1162318; AID1202608; AID1243861; AID1681852; AID1796976; AID255023; AID527394; AID693265; AID696047
Coagulation factor XHomo sapiens (human)Ki0.00090.00000.47089.0000AID1057659; AID1393330; AID1517792; AID351693; AID527394; AID753178
Coagulation factor XIIHomo sapiens (human)IC50 (µMol)33.00000.01043.889010.9666AID1681854
Canalicular multispecific organic anion transporter 1Homo sapiens (human)IC50 (µMol)133.00002.41006.343310.0000AID1473739
Suppressor of tumorigenicity 14 proteinHomo sapiens (human)Ki3.35000.00000.87113.3500AID1195362
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (90)

Processvia Protein(s)Taxonomy
xenobiotic metabolic processATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
bile acid and bile salt transportATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transportATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
leukotriene transportATP-binding cassette sub-family C member 3Homo sapiens (human)
monoatomic anion transmembrane transportATP-binding cassette sub-family C member 3Homo sapiens (human)
transport across blood-brain barrierATP-binding cassette sub-family C member 3Homo sapiens (human)
prostaglandin secretionMultidrug resistance-associated protein 4Homo sapiens (human)
cilium assemblyMultidrug resistance-associated protein 4Homo sapiens (human)
platelet degranulationMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic metabolic processMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
bile acid and bile salt transportMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transportMultidrug resistance-associated protein 4Homo sapiens (human)
urate transportMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
cAMP transportMultidrug resistance-associated protein 4Homo sapiens (human)
leukotriene transportMultidrug resistance-associated protein 4Homo sapiens (human)
monoatomic anion transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
export across plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
transport across blood-brain barrierMultidrug resistance-associated protein 4Homo sapiens (human)
guanine nucleotide transmembrane transportMultidrug resistance-associated protein 4Homo sapiens (human)
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
positive regulation of protein phosphorylationProthrombinHomo sapiens (human)
proteolysisProthrombinHomo sapiens (human)
acute-phase responseProthrombinHomo sapiens (human)
cell surface receptor signaling pathwayProthrombinHomo sapiens (human)
G protein-coupled receptor signaling pathwayProthrombinHomo sapiens (human)
blood coagulationProthrombinHomo sapiens (human)
positive regulation of cell population proliferationProthrombinHomo sapiens (human)
regulation of cell shapeProthrombinHomo sapiens (human)
response to woundingProthrombinHomo sapiens (human)
negative regulation of platelet activationProthrombinHomo sapiens (human)
platelet activationProthrombinHomo sapiens (human)
regulation of blood coagulationProthrombinHomo sapiens (human)
positive regulation of blood coagulationProthrombinHomo sapiens (human)
positive regulation of cell growthProthrombinHomo sapiens (human)
positive regulation of insulin secretionProthrombinHomo sapiens (human)
positive regulation of collagen biosynthetic processProthrombinHomo sapiens (human)
fibrinolysisProthrombinHomo sapiens (human)
negative regulation of proteolysisProthrombinHomo sapiens (human)
positive regulation of receptor signaling pathway via JAK-STATProthrombinHomo sapiens (human)
negative regulation of astrocyte differentiationProthrombinHomo sapiens (human)
positive regulation of release of sequestered calcium ion into cytosolProthrombinHomo sapiens (human)
regulation of cytosolic calcium ion concentrationProthrombinHomo sapiens (human)
cytolysis by host of symbiont cellsProthrombinHomo sapiens (human)
positive regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionProthrombinHomo sapiens (human)
negative regulation of fibrinolysisProthrombinHomo sapiens (human)
antimicrobial humoral immune response mediated by antimicrobial peptideProthrombinHomo sapiens (human)
neutrophil-mediated killing of gram-negative bacteriumProthrombinHomo sapiens (human)
positive regulation of lipid kinase activityProthrombinHomo sapiens (human)
negative regulation of cytokine production involved in inflammatory responseProthrombinHomo sapiens (human)
positive regulation of protein localization to nucleusProthrombinHomo sapiens (human)
positive regulation of phospholipase C-activating G protein-coupled receptor signaling pathwayProthrombinHomo sapiens (human)
ligand-gated ion channel signaling pathwayProthrombinHomo sapiens (human)
positive regulation of reactive oxygen species metabolic processProthrombinHomo sapiens (human)
proteolysisCoagulation factor XHomo sapiens (human)
blood coagulationCoagulation factor XHomo sapiens (human)
positive regulation of cell migrationCoagulation factor XHomo sapiens (human)
positive regulation of TOR signalingCoagulation factor XHomo sapiens (human)
plasma kallikrein-kinin cascadeCoagulation factor XIIHomo sapiens (human)
Factor XII activationCoagulation factor XIIHomo sapiens (human)
blood coagulation, intrinsic pathwayCoagulation factor XIIHomo sapiens (human)
positive regulation of plasminogen activationCoagulation factor XIIHomo sapiens (human)
protein processingCoagulation factor XIIHomo sapiens (human)
protein autoprocessingCoagulation factor XIIHomo sapiens (human)
positive regulation of blood coagulationCoagulation factor XIIHomo sapiens (human)
zymogen activationCoagulation factor XIIHomo sapiens (human)
fibrinolysisCoagulation factor XIIHomo sapiens (human)
innate immune responseCoagulation factor XIIHomo sapiens (human)
response to misfolded proteinCoagulation factor XIIHomo sapiens (human)
positive regulation of fibrinolysisCoagulation factor XIIHomo sapiens (human)
blood coagulationCoagulation factor XIIHomo sapiens (human)
xenobiotic metabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
negative regulation of gene expressionCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bile acid and bile salt transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
heme catabolic processCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic export from cellCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transepithelial transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
leukotriene transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
monoatomic anion transmembrane transportCanalicular multispecific organic anion transporter 1Homo sapiens (human)
transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transport across blood-brain barrierCanalicular multispecific organic anion transporter 1Homo sapiens (human)
neural tube closureSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
proteolysisSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
protein catabolic processSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
keratinocyte differentiationSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
epithelial cell morphogenesis involved in placental branchingSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (34)

Processvia Protein(s)Taxonomy
ATP bindingATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type xenobiotic transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
glucuronoside transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type bile acid transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATP hydrolysis activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
xenobiotic transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
icosanoid transmembrane transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
ABC-type transporter activityATP-binding cassette sub-family C member 3Homo sapiens (human)
guanine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ATP bindingMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type xenobiotic transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
prostaglandin transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
urate transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
purine nucleotide transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type bile acid transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
efflux transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
15-hydroxyprostaglandin dehydrogenase (NAD+) activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATP hydrolysis activityMultidrug resistance-associated protein 4Homo sapiens (human)
glutathione transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
xenobiotic transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
ABC-type transporter activityMultidrug resistance-associated protein 4Homo sapiens (human)
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
lipopolysaccharide bindingProthrombinHomo sapiens (human)
serine-type endopeptidase activityProthrombinHomo sapiens (human)
signaling receptor bindingProthrombinHomo sapiens (human)
calcium ion bindingProthrombinHomo sapiens (human)
protein bindingProthrombinHomo sapiens (human)
growth factor activityProthrombinHomo sapiens (human)
heparin bindingProthrombinHomo sapiens (human)
thrombospondin receptor activityProthrombinHomo sapiens (human)
serine-type endopeptidase activityCoagulation factor XHomo sapiens (human)
calcium ion bindingCoagulation factor XHomo sapiens (human)
protein bindingCoagulation factor XHomo sapiens (human)
phospholipid bindingCoagulation factor XHomo sapiens (human)
serine-type endopeptidase activityCoagulation factor XIIHomo sapiens (human)
calcium ion bindingCoagulation factor XIIHomo sapiens (human)
protein bindingCoagulation factor XIIHomo sapiens (human)
misfolded protein bindingCoagulation factor XIIHomo sapiens (human)
protein bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP bindingCanalicular multispecific organic anion transporter 1Homo sapiens (human)
organic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type xenobiotic transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
bilirubin transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type glutathione S-conjugate transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATP hydrolysis activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
xenobiotic transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ATPase-coupled inorganic anion transmembrane transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
ABC-type transporter activityCanalicular multispecific organic anion transporter 1Homo sapiens (human)
serine-type endopeptidase activitySuppressor of tumorigenicity 14 proteinHomo sapiens (human)
serine-type peptidase activitySuppressor of tumorigenicity 14 proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (25)

Processvia Protein(s)Taxonomy
plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basal plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
basolateral plasma membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
membraneATP-binding cassette sub-family C member 3Homo sapiens (human)
nucleolusMultidrug resistance-associated protein 4Homo sapiens (human)
Golgi apparatusMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
platelet dense granule membraneMultidrug resistance-associated protein 4Homo sapiens (human)
external side of apical plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
plasma membraneMultidrug resistance-associated protein 4Homo sapiens (human)
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
external side of plasma membraneProthrombinHomo sapiens (human)
collagen-containing extracellular matrixProthrombinHomo sapiens (human)
extracellular regionProthrombinHomo sapiens (human)
extracellular spaceProthrombinHomo sapiens (human)
endoplasmic reticulum lumenProthrombinHomo sapiens (human)
Golgi lumenProthrombinHomo sapiens (human)
plasma membraneProthrombinHomo sapiens (human)
extracellular exosomeProthrombinHomo sapiens (human)
blood microparticleProthrombinHomo sapiens (human)
collagen-containing extracellular matrixProthrombinHomo sapiens (human)
extracellular spaceProthrombinHomo sapiens (human)
extracellular regionCoagulation factor XHomo sapiens (human)
endoplasmic reticulum lumenCoagulation factor XHomo sapiens (human)
Golgi lumenCoagulation factor XHomo sapiens (human)
plasma membraneCoagulation factor XHomo sapiens (human)
external side of plasma membraneCoagulation factor XHomo sapiens (human)
extracellular spaceCoagulation factor XHomo sapiens (human)
extracellular regionCoagulation factor XIIHomo sapiens (human)
extracellular spaceCoagulation factor XIIHomo sapiens (human)
plasma membraneCoagulation factor XIIHomo sapiens (human)
collagen-containing extracellular matrixCoagulation factor XIIHomo sapiens (human)
extracellular exosomeCoagulation factor XIIHomo sapiens (human)
extracellular spaceCoagulation factor XIIHomo sapiens (human)
rough endoplasmic reticulumCoagulation factor XIIHomo sapiens (human)
plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
cell surfaceCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
intercellular canaliculusCanalicular multispecific organic anion transporter 1Homo sapiens (human)
apical plasma membraneCanalicular multispecific organic anion transporter 1Homo sapiens (human)
extracellular spaceSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
plasma membraneSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
external side of plasma membraneSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
basolateral plasma membraneSuppressor of tumorigenicity 14 proteinHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (148)

Assay IDTitleYearJournalArticle
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1473739Inhibition of human MRP2 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1517811Half life in Wistar rat at 22 umol/kg, po measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID753178Inhibition of F10a (unknown origin) using S-2222 as substrate incubated for 15 mins prior to substrate addition measured every 10 secs by spectrophotometric analysis2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID1162365Induction of tail bleeding in rat assessed as prolongation of bleeding time dosed orally 60 mins before surgery2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID693264Anticoagulant activity in human plasma assessed as concentration required to double prothrombin time2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
AID1057659Inhibition of factor-10a (unknown origin)2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1162357AUC (0 to infinity) in Beagle dog at 1 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID253820Mean half-life after intravenous administration to rats at a dose of 1 and 3 mg/kg2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1517826Antithrombotic activity in Wistar rat plasma assessed as dry weight of thrombus at 22 umol/kg, po measured after 1 hr (Rvb = 0.120 +/- 0.045 g)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1162328Anticoagulant activity in citrated rabbit plasma assessed as drug concentration required to double plasma clotting time preincubated for 10 mins at 37 degC by coagulometry2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1162329Anticoagulant activity in citrated rabbit plasma assessed as activated partial thromboplastin time preincubated for 10 mins at 37 degC by coagulometry2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1517812AUC (0 to infinity) in Wistar rat at 22 umol/kg, po measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID527408Half life in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527394Inhibition of factor 10a2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID351695Anticoagulant activity in human plasma assessed as concentration required to double the thrombin generation time2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide, a highly potent, selective, and orally efficacious factor Xa inhibitor.
AID1057658Inhibition of thrombin (unknown origin)2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1202606Inhibition of F10a in rabbit plasma assessed as doubling of prothombin time2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structure-activity relationship of oxazolidinone derivatives containing novel S4 ligand as FXa inhibitors.
AID1057598Antithrombotic activity in CD rat wire coil model assessed as fold loss of blood at ED80, po administered 30 to 90 mins before thromboplastin relative to control2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1162345AUC (0 to infinity) in Sprague-Dawley rat at 3 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1681854Inhibition of human coagulation factor XIIA using Boc-Gln-Gly-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID527433Protein binding in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID253590Mean plasma clearance in female Beagle dogs after intravenous administration of the compound at a dose of 0.3 and 1 mg/kg2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1162364Antithrombotic activity in rat model of electrically-induced rat carotid artery thrombosis assessed as reduction in thrombus formation dosed orally 45 mins before induction of anesthesia2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1517815Volume of distribution in Wistar rat at 22 umol/kg, po measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1393332Selectivity ratio of IC50 for human factor 9a to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1517827Antithrombotic activity in Wistar rat plasma assessed as thrombus formation time at 22 umol/kg, po measured after 1 hr (Rvb = 9.4 +/- 8.9 mins)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1517814Clearance in Wistar rat at 22 umol/kg, po measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1473741Inhibition of human MRP4 overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1393339Oral bioavailability in human at 10 mg2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID527412Oral bioavailability in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID351693Inhibition of Factor 10a2009Bioorganic & medicinal chemistry letters, Apr-15, Volume: 19, Issue:8
Discovery of betrixaban (PRT054021), N-(5-chloropyridin-2-yl)-2-(4-(N,N-dimethylcarbamimidoyl)benzamido)-5-methoxybenzamide, a highly potent, selective, and orally efficacious factor Xa inhibitor.
AID1393333Selectivity ratio of IC50 for human factor 11a to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1517821Volume of distribution in Wistar rat at 6.6 umol/kg, iv measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID527438Drug excretion in dog feces2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527439Drug excretion in dog urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID255704In vivo antithrombotic activity of compound in the arteriovenous shunt model in anesthetized rats after intravenous administration2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1681852Inhibition of human coagulation factor Xa using Boc-Ile-Glu-Gly-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1243862Antithrombotic activity in FeCl3-induced venous thrombosis rat model assessed as thrombus weight at 100g/ml, po (Rvb = 7.8 +/- 1.6 mg)2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis of 3,4-diaminobenzoyl derivatives as factor Xa inhibitors.
AID253616Fraction of unbound compound in rat plasma2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1623335Anticoagulant activity in human platelet poor plasma assessed as activated partial thromboplastin time at 100 uM incubated for 15 mins at room temperature and subsequent incubation for 2 mins at 37 degreeC followed by cephalin addition and measured after 2019European journal of medicinal chemistry, Feb-15, Volume: 164Translational impact of novel widely pharmacological characterized mofezolac-derived COX-1 inhibitors combined with bortezomib on human multiple myeloma cell lines viability.
AID1393336Selectivity ratio of IC50 for plasmin to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1162361Oral bioavailability in Beagle dog at 1 mg/kg2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1162353Cmax in Beagle dog at 1 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID693266Anticoagulant activity in rat plasma assessed as concentration required to double prothrombin time2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
AID1473740Inhibition of human MRP3 overexpressed in Sf9 insect cell membrane vesicles assessed as uptake of [3H]-estradiol-17beta-D-glucuronide in presence of ATP and GSH measured after 10 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1162360Volume of distribution at steady state in Beagle dog at 0.5 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1162363Antithrombotic activity in rat model of arteriovenous shunt-induced thrombosis assessed as reduction in thrombus formation dosed orally 60 mins before shunt opening2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID527393Clearance in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1195362Inhibition of matripase (unknown origin) using Boc-QAR-AMC as substrate incubated for 30 mins prior to substrate addition by fluorescence assay2015Bioorganic & medicinal chemistry, May-15, Volume: 23, Issue:10
Structure-based discovery of small molecule hepsin and HGFA protease inhibitors: Evaluation of potency and selectivity derived from distinct binding pockets.
AID1162337Elimination half life in Sprague-Dawley rat at 3 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1162358AUC (0 to infinity) in Beagle dog at 0.5 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1202603Inhibition of human F10a using S-2765 as substrate at 0.1 uM after 45 mins by spectra max analysis relative to control2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structure-activity relationship of oxazolidinone derivatives containing novel S4 ligand as FXa inhibitors.
AID527437Drug excretion in rat urine2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1057602Antithrombotic activity in po dosed CD rat wire coil model assessed as reduction of protein content administered 30 to 90 mins before thromboplastin2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID693267Prolongation of prothrombin time in rat at 30 mg/kg, po after 2 hrs relative to vehicle-treated control2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
AID253691Mean apparent volume of distribution at equilibrium after intravenous administration in rats at a dose of 1 and 3 mg/kg2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1202608Inhibition of human F10a using S-2765 as substrate after 45 mins by spectra max analysis2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structure-activity relationship of oxazolidinone derivatives containing novel S4 ligand as FXa inhibitors.
AID527434Protein binding in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID256439In vitro inhibitory concentration of compound required to double the time to fibrin formation upon incubation with human plasma for 10 minutes at 37 degrees C2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1393331Selectivity ratio of IC50 for human factor 7a to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1681826Non-covalent inhibition of human coagulation factor XIIA using Boc-Gln-Gly-Arg-AMC as fluorogenic substrate measured every 87 sec for 180 mins by time-dependent fluorescence assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1450209Effect on prothrombin time in rat at 1 to 100 mg/kg, po measured after 2 hrs2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Discovery of novel aminobenzisoxazole derivatives as orally available factor IXa inhibitors.
AID1517820Clearance in Wistar rat at 6.6 umol/kg, iv measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1162346Plasma clearance in Sprague-Dawley rat at 3 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID253572Bioavailability in female Beagle dog is the mean value of AUCnorm perorally to AUCnorm intravenously2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1393335Selectivity ratio of IC50 for human activated protein C to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1517825Antithrombotic activity in Wistar rat plasma assessed as wet weight of thrombus at 22 umol/kg, po measured after 1 hr (Rvb = 0.403 +/- 0.183 g)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID527410Volume of distribution at steady state in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1162362Antithrombotic activity in rat model of FeCl3-induced venous thrombosis assessed as reduction in thrombus formation dosed orally 60 mins before thrombus formation2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1623336Anticoagulant activity in human platelet poor plasma assessed as prothrombin time at 100 uM incubated for 15 mins at room temperature and subsequent incubation for 2 mins at 37 degreeC followed by PBS addition and measured after 3 mins for every secs in p2019European journal of medicinal chemistry, Feb-15, Volume: 164Translational impact of novel widely pharmacological characterized mofezolac-derived COX-1 inhibitors combined with bortezomib on human multiple myeloma cell lines viability.
AID1517819MRT in Wistar rat at 6.6 umol/kg, iv measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID753175Displacement of biotinylated fibrinogen from human glycoprotein 2b/3a receptor after 2 hrs by chemiluminescence assay2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID527418Tmax in po dosed human2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1517791Cmax in Wistar rat at 22 umol/kg, po measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID696048Inhibition of human factor 10a assessed as CBS 31.39 substrate hydrolysis at 5 x 10'-9 M by spectrophotometric analysis2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Polysulfated xanthones: multipathway development of a new generation of dual anticoagulant/antiplatelet agents.
AID527392Volume of distribution at steady state in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID527428Antithrombotic activity in rabbit arteriovenous-shunt thrombosis model measured per hr2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1393334Selectivity ratio of IC50 for human thrombin to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID527436Drug excretion in rat feces2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID753176Inhibition of trypsin (unknown origin) using S-2222 as substrate incubated for 15 mins prior to substrate addition measured every 10 secs by spectrophotometric analysis2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID253827Mean half-life after intravenous administration to female Beagle dogs at a dose of 0.3 and 1 mg/kg2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1681850Effect on blood coagulation in human blood assessed as increase in prothrombin time at 300 uM incubated for 3 mins followed by CaCl2 addition by PT reagent based assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID253570Oral bioavailability in rat2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1162335Tmax in Sprague-Dawley rat at 3 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1162359Plasma clearance in Beagle dog at 0.5 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1681849Anticoagulant activity in human blood assessed as increase in activated partial thromboplastin time at 300 uM incubated for 1 min by aPTT reagent based assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID527409Clearance in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID696047Inhibition of human factor 10a assessed as CBS 31.39 substrate hydrolysis by spectrophotometric analysis2011Journal of medicinal chemistry, Aug-11, Volume: 54, Issue:15
Polysulfated xanthones: multipathway development of a new generation of dual anticoagulant/antiplatelet agents.
AID1162348Volume of distribution at steady state in Sprague-Dawley rat at 3 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1517817Half life in Wistar rat at 6.6 umol/kg, iv measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1057646Reduction of thrombin generation time in human platelet-rich plasma by spectrophotometer analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1162352Oral bioavailability in Sprague-Dawley rat at 3 mg/kg2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID527398Anticoagulant activity in human platelet assessed as concentration required to double activated partial prothrombin time2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1162355Elimination half life in Beagle dog at 1 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID255703In vivo antithrombotic activity of compound in the arteriovenous shunt model in anesthetized rats after peroral administration2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1202604Inhibition of F10a in human plasma assessed as doubling of prothombin time2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structure-activity relationship of oxazolidinone derivatives containing novel S4 ligand as FXa inhibitors.
AID527413Half life in rat2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1517813MRT in Wistar rat at 22 umol/kg, po measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1393337Selectivity ratio of IC50 for urokinase to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1057649Reduction of thrombin generation time in human platelet-poor plasma by spectrophotometer analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1202605Inhibition of F10a in human plasma assessed as doubling of activated partial thromboplastin time2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structure-activity relationship of oxazolidinone derivatives containing novel S4 ligand as FXa inhibitors.
AID253617Fraction of unbound compound in female Beagle dog plasma2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID253589Mean plasma clearance in wistar rats after intravenous administration of the compound at a dose of 1 and 3 mg/kg2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1057648Reduction of thrombin generation time in rat platelet-poor plasma by spectrophotometer analysis relative to control2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1517823Anticoagulant activity in Wistar rat plasma assessed as aPTT time at 22 umol/kg, po measured after 1 hr by anticoagulant auto-analyser (Rvb = 18 +/- 0.9 sec)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1162342AUC (0 to infinity) in Sprague-Dawley rat at 3 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1162354Tmax in Beagle dog at 1 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1202607Inhibition of F10a in rabbit plasma assessed as doubling of activated partial thromboplastin time2015European journal of medicinal chemistry, , Volume: 96Design, synthesis and structure-activity relationship of oxazolidinone derivatives containing novel S4 ligand as FXa inhibitors.
AID1585431Cytoprotective activity against hypoxia/reoxygenation-induced toxicity in rat H9c2 cells assessed as increase in cell viability at 1 to 10 uM by MTT assay2018Bioorganic & medicinal chemistry, 12-15, Volume: 26, Issue:23-24
Design, synthesis and biological evaluation of anthranilamide derivatives as potential factor Xa (fXa) inhibitors.
AID1681851Inhibition of porcine trypsin using Z-Gly-Gly-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID693287Antithrombotic activity in FeCl3-induced venous thrombosis Wistar rat model assessed as reduction in thrombus weight at 10 mg/kg, po after 2 hrs2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
AID253692Mean apparent volume of distribution at equilibrium after administration in female Beagle dogs at a dose of 0.3 and 1 mg kg-1 intravenously2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1162340Elimination half life in Sprague-Dawley rat at 3 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID527407Oral bioavailability in dog2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1681839Inhibition of human coagulation factor XIIA in presence of Boc-Gln-Gly-Arg-AMC as fluorogenic substrate at 1 uM measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID1681833Inhibition of human coagulation factor alpha-thrombin at 33 uM using Boc-Val-Pro-Arg-AMC as fluorogenic substrate measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID255023In vitro inhibition of human coagulation factor Xa after incubation for 10 min at 25 degree C2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID693261Antithrombotic activity in FeCl3-induced arterial thrombosis Wistar rat model assessed as reduction in thrombus weight at 10 mg/kg, po after 2 hrs2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
AID1517816Oral bioavailability in Wistar rat at 22 umol/kg measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1681838Inhibition of human coagulation factor alpha thrombin in presence of Boc-Val-Pro-Arg-AMC as fluorogenic substrate at 1 uM measured at 1 min interval for 1 hr by fluorometric assay relative to control2020Journal of medicinal chemistry, 11-12, Volume: 63, Issue:21
Acylated 1
AID256438In vitro inhibitory concentration of compound required to double the time to fibrin formation upon incubation with rat plasma for 10 minutes at 37 degrees C2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1393338Selectivity ratio of IC50 for trypsin to Ki for human factor 10a2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID693265Inhibition of human F10a using S-2765 as substrate after 45 mins2012European journal of medicinal chemistry, Dec, Volume: 58Synthesis and structure-activity relationship of potent, selective and orally active anthranilamide-based factor Xa inhibitors: application of weakly basic sulfoximine group as novel S4 binding element.
AID1393330Inhibition of human factor 10a using pefachrome F10a as substrate preincubated for 10 mins followed by substrate addition and measured for 20 mins2018Journal of medicinal chemistry, 05-10, Volume: 61, Issue:9
Design of Small-Molecule Active-Site Inhibitors of the S1A Family Proteases as Procoagulant and Anticoagulant Drugs.
AID1473738Inhibition of human BSEP overexpressed in Sf9 cell membrane vesicles assessed as uptake of [3H]-taurocholate in presence of ATP measured after 15 to 20 mins by membrane vesicle transport assay2013Toxicological sciences : an official journal of the Society of Toxicology, Nov, Volume: 136, Issue:1
A multifactorial approach to hepatobiliary transporter assessment enables improved therapeutic compound development.
AID1517818AUC (0 to infinity) in Wistar rat at 6.6 umol/kg, iv measured upto 24 hrs by LC-MS/MS analysis2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1517822Anticoagulant activity in Wistar rat plasma assessed as prothrombin time at 22 umol/kg, po measured after 1 hr by anticoagulant auto-analyser (Rvb = 16.1 +/- 0.6 sec)2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1243861Inhibition of human F10a using S-2765 as substrate preincubated for 10 mins followed by substrate addition by microplate reader analysis2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis of 3,4-diaminobenzoyl derivatives as factor Xa inhibitors.
AID753177Inhibition of thrombin (unknown origin) using S-2238 as substrate incubated for 15 mins prior to substrate addition measured every 10 secs by spectrophotometric analysis2013European journal of medicinal chemistry, Jun, Volume: 64Low molecular weight dual inhibitors of factor Xa and fibrinogen binding to GPIIb/IIIa with highly overlapped pharmacophores.
AID1450207Anticoagulant activity in po dosed rat assessed as prolongation of activated partial thromboplastin time measured after 2 hrs2017Bioorganic & medicinal chemistry letters, 06-01, Volume: 27, Issue:11
Discovery of novel aminobenzisoxazole derivatives as orally available factor IXa inhibitors.
AID1162356Elimination half life in Beagle dog at 0.5 mg/kg, iv2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1517792Inhibition of human activated Factor X using S-2765 as substrate incubated for 15 mins followed by substrate addition and measured after 1 hr by chromogenic assay2019European journal of medicinal chemistry, Dec-01, Volume: 183Discovery of novel, potent, isosteviol-based antithrombotic agents.
AID1057650Reduction of thrombin generation time in rat platelet-poor plasma by spectrophotometer analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
5-Chlorothiophene-2-carboxylic acid [(S)-2-[2-methyl-3-(2-oxopyrrolidin-1-yl)benzenesulfonylamino]-3-(4-methylpiperazin-1-yl)-3-oxopropyl]amide (SAR107375), a selective and potent orally active dual thrombin and factor Xa inhibitor.
AID1162318Inhibition of human factor 10a using N-Z-D-Arg-Gly-Arg-pNA, S-2765 chromogenic substrate2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID527399Anticoagulant activity in human platelet assessed as concentration required to double prothrombin time2010Journal of medicinal chemistry, Sep-09, Volume: 53, Issue:17
Factor Xa inhibitors: next-generation antithrombotic agents.
AID1243860Inhibition of F10a in rabbit plasma assessed as ratio of compound prothrombin time to vehicle control prothrombin time at 100 nM after 2 mins by automatic coagulation analyser2015European journal of medicinal chemistry, Aug-28, Volume: 101Synthesis of 3,4-diaminobenzoyl derivatives as factor Xa inhibitors.
AID1191446Inhibition of human F10a using chromogenic substrate S-2765 preincubated for 10 mins at 0.1 uM by spectrophotometry2015Bioorganic & medicinal chemistry letters, Feb-01, Volume: 25, Issue:3
Design, synthesis and evaluation of isoxazolo[5,4-d]pyrimidin-4(5H)-one derivatives as antithrombotic agents.
AID1162332Cmax in Sprague-Dawley rat at 3 mg/kg, po2014Journal of medicinal chemistry, Sep-25, Volume: 57, Issue:18
Design, synthesis, and structure-activity and structure-pharmacokinetic relationship studies of novel [6,6,5] tricyclic fused oxazolidinones leading to the discovery of a potent, selective, and orally bioavailable FXa inhibitor.
AID1796976Enzyme Inhibition Assay from Article 10.1021/jm050101d: \\Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene-2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhi2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1345896Human coagulation factor X (S1: Chymotrypsin)2010Arteriosclerosis, thrombosis, and vascular biology, Mar, Volume: 30, Issue:3
Rivaroxaban: a new oral factor Xa inhibitor.
AID977610Experimentally measured binding affinity data (Ki) for protein-ligand complexes derived from PDB2005Journal of medicinal chemistry, Sep-22, Volume: 48, Issue:19
Discovery of the novel antithrombotic agent 5-chloro-N-({(5S)-2-oxo-3- [4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl}methyl)thiophene- 2-carboxamide (BAY 59-7939): an oral, direct factor Xa inhibitor.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (4,542)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's123 (2.71)29.6817
2010's2942 (64.77)24.3611
2020's1477 (32.52)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 127.04

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index127.04 (24.57)
Research Supply Index8.58 (2.92)
Research Growth Index6.20 (4.65)
Search Engine Demand Index238.08 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (127.04)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials569 (12.00%)5.53%
Reviews1,008 (21.26%)6.00%
Case Studies480 (10.12%)4.05%
Observational261 (5.51%)0.25%
Other2,423 (51.11%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (431)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Prospective, Randomized Clinical Trial Comparing Rivaroxaban vs Warfarin in High Risk Patients With Antiphospholipid Syndrome [NCT02157272]Phase 3121 participants (Actual)Interventional2014-12-31Terminated(stopped due to Unbalance in the composite endpoint between arms.)
Comparative Study of Oral Anticoagulation in Patients With Left Ventricular Thrombi [NCT03926780]Phase 379 participants (Actual)Interventional2018-12-01Completed
RIvoraxaban Safety and Efficacy in Patients With Mitral Stenosis [NCT03926156]Phase 340 participants (Actual)Interventional2019-05-22Terminated(stopped due to COVID-19 has impacted our study recruitment)
A Prospective Randomized Controlled Trial of Rivaroxaban Versus Warfarin in Dissolving Left Atrial Appendage Thrombus in Patients With Atrial Fibrillation [NCT03792152]80 participants (Anticipated)Interventional2019-06-01Not yet recruiting
A Prospective, Randomized, Open-label, Multicenter Study Comparing Rivaroxaban 2.5 mg Twice Daily Associated With Aspirin 100 mg Once Daily Versus Aspirin 100 mg Once Daily in Patients With Peripheral Arterial Disease and Limiting Intermittent Claudicatio [NCT04853719]Phase 488 participants (Actual)Interventional2021-04-20Completed
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United Kingdom Cohort (OSCAR-UK) [NCT05112666]2,601 participants (Actual)Observational2021-12-02Completed
Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing [NCT01206972]Phase 3302 participants (Actual)Interventional2010-10-31Completed
Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS [NCT03775746]Phase 4150 participants (Anticipated)Interventional2019-01-08Recruiting
A Randomized, Controlled, Phase 2b Study to Evaluate Safety and Efficacy of Rivaroxaban (Xarelto®) for High Risk People With Mild COVID-19 [NCT04504032]Phase 2497 participants (Actual)Interventional2020-09-02Terminated(stopped due to Based on Data Monitoring Committee''s recommendation on 3 February 2021, the study was stopped on 4 February 2021 due to futility.)
Treatment Patterns and Clinical Outcomes Among Venous Thromboembolism Patients Treated With Anticoagulants After the Entry of Non-vitamin K Antagonist Oral Anticoagulants in Korea [NCT05022563]55,759 participants (Actual)Observational2021-08-31Completed
Identification of Clinical and Pharmacogenetic Factors Predictive of Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation. [NCT04297150]700 participants (Anticipated)Observational2020-06-18Active, not recruiting
Reversion of the Anticoagulant Effect of the New Antithrombotic Agents Anti-Xa and Anti IIa by Specific and Non-specific Haemostatic Drugs,: an Ex-Vivo Study in Healthy Volunteers [NCT01210755]Phase 410 participants (Anticipated)Interventional2010-11-30Completed
Rivaroxaban Estimation With Warfarin in Atrial Fibrillation Patients With Coronary Stent Implantation Study (REWRAPS) [NCT02024230]Phase 4500 participants (Actual)Interventional2014-01-31Completed
Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism [NCT01145859]Phase 159 participants (Actual)Interventional2010-11-30Completed
Randomized Comparison of a Rivaroxaban-based Strategy With an Antiplatelet-based Strategy Following Successful TAVR for the Prevention of Leaflet Thickening and Reduced Leaflet Motion as Evaluated by Four-dimensional, Volume-rendered Computed Tomography ( [NCT02833948]Phase 3231 participants (Actual)Interventional2016-05-31Completed
Comparison of Combined Topical Tranexamic Acid With Floseal® With Intravenous Tranexamic Acid on Blood Loss in Total Knee Arthroplasty [NCT03328832]Phase 470 participants (Actual)Interventional2017-09-12Completed
Effect of Anticoagulation Therapy on Clinical Outcomes in Moderate to Severe Coronavirus Disease 2019 (COVID-19) [NCT04416048]Phase 2111 participants (Actual)Interventional2020-11-30Terminated(stopped due to Due to lower COVID-19 cases and therefore difficulties with the recruitment.)
The Efficacy and Safety of Rivaroxaban for Thromboprophylaxis in High-risk Cancer Patients With Totally Implantable Access Ports: a Prospective Randomized Controlled Trial [NCT04309240]Phase 3204 participants (Anticipated)Interventional2020-03-08Not yet recruiting
Pattern of Use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation Patients in UK General Practices [NCT03119116]31,336 participants (Actual)Observational2017-05-15Completed
Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery [NCT02438098]Phase 113 participants (Actual)Interventional2015-06-30Completed
A Multicentre, Randomised, Double-blind, Controlled, Phase IIIb Study to Assess the Efficacy and Safety of Rivaroxaban 10mg od Versus Enoxaparin 4000 UI for VTE PROphylaxis in NOn Major Orthopaedic Surgery [NCT02401594]Phase 33,608 participants (Actual)Interventional2015-12-08Terminated(stopped due to Remaining outdated treatments and additional costs too high for new manufacturing)
Descriptive Analysis of VTE Treatment With Rivaroxaban in Japanese Clinical Practice Using a Claims Database [NCT04923139]2,627 participants (Actual)Observational2022-01-24Completed
Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study [NCT03181386]Phase 360 participants (Actual)Interventional2017-05-03Completed
Anticoagulant Plus Antiplatelet Therapy Following Iliac Vein Stenting [NCT04694248]172 participants (Anticipated)Interventional2021-11-03Recruiting
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects [NCT03310021]Phase 2108 participants (Actual)Interventional2017-08-28Completed
Comparison of Oral Anticoagulants for Extended VEnous Thromboembolism (COVET) [NCT03196349]Phase 444 participants (Actual)Interventional2018-08-01Terminated(stopped due to Lack of enrollment)
Intracerebral Hemorrhage Due to Oral Anticoagulants in the Secondary Prevention of Ischemic Stroke: Prediction of the Risk by the Detection of Leukoaraiosis and Microbleeding With Magnetic Resonance [NCT02238470]1,000 participants (Actual)Observational [Patient Registry]2012-04-30Completed
Effects of Hypericum Perforatum (St. John's Wort) on the Pharmacokinetics and Pharmacodynamics of Rivaroxaban in Humans [NCT03796377]Phase 112 participants (Actual)Interventional2019-02-13Completed
Efficacy and Safety of Anticoagulant on Early Treatment of Post-STEMI Left Ventricular Thrombus: an Open, Prospective, Randomized and Multi-centers Trial. [NCT03764241]Phase 3280 participants (Anticipated)Interventional2020-02-01Recruiting
Influence of Rivaroxaban Compared to Vitamin K Antagonist Treatment Upon Development of Cardiovascular Calcification in Patients With Atrial Fibrillation and/ or Pulmonary Embolism (IRIVASC- Trial) [NCT02066662]Phase 4192 participants (Actual)Interventional2013-07-31Completed
Comparing Treatment Outcomes in CVT Patients Who Treated With Warfarin and Rivaroxaban in Isfahan, Iran [NCT03747081]Phase 1/Phase 250 participants (Anticipated)Interventional2018-09-01Recruiting
Rivaroxaban in Antiphospholipid Syndrome Pilot Study: A Multicenter Feasibility Study of Rivaroxaban for Patients With Antiphospholipid Syndrome and Prior Arterial or Venous Thrombosis [NCT02116036]Phase 481 participants (Actual)Interventional2014-09-30Completed
A Phase III, Multi-centre, Randomized Trial to Compare Rivaroxaban With Placebo for the Treatment of Symptomatic Leg Superficial Vein Thrombosis [NCT02123524]Phase 385 participants (Actual)Interventional2014-11-11Completed
Evaluation of Non-Vitamin K Antagonist Oral Anticoagulants Concentration Among Patients With Acute Stroke (The Direct Oral AntiCoagulant Registry in Taiwan-Emergent Department, DOACT-ED) [NCT06144866]1,000 participants (Anticipated)Observational [Patient Registry]2020-05-01Recruiting
Anti-Coronavirus Therapies to Prevent Progression of COVID-19, a Randomized Trial [NCT04324463]Phase 36,667 participants (Actual)Interventional2020-04-21Active, not recruiting
A Phase IV Study to Investigate the Safety and Effectiveness of Rivaroxaban(Xarelto) 2.5mg [BID]+Acetylsalicylic Acid(ASA) 75mg [OD] in Indian Patients With Coronary and/or Symptomatic Peripheral Artery Disease [NCT04298567]300 participants (Actual)Observational2022-02-25Active, not recruiting
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease [NCT03969953]Phase 32,000 participants (Anticipated)Interventional2020-12-14Recruiting
Safety and Effectiveness of Direct Oral Anticoagulants for Stroke Prevention in Non-valvular Atrial Fibrillation: a Multi-database Cohort Study With Meta-analysis (DOACs vs DOACs) [NCT03568916]227,579 participants (Actual)Observational2016-11-30Completed
Evaluation of Wound Drainage Following Rivaroxaban (Xarelto) or Warfarin (Coumadin) for Post op Venous Thromboembolism (VTE) Prophylaxis, After Knee or Hip Arthroplasty a Randomized Study. [NCT02054936]Phase 40 participants (Actual)Interventional2014-03-31Withdrawn(stopped due to Change in standard of care, no possibility of recruitment)
Safety and Efficacy of Low Molecular Weight Heparin Versus Rivaroxaban in Chinese Patients Hospitalized With Acute Coronary Syndrome(H-REPLACE): a Prospective, Randomized, Open-label, Active-controlled, Multicenter Trial [NCT03363035]Phase 42,055 participants (Actual)Interventional2018-01-15Completed
Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban. [NCT02085824]60 participants (Anticipated)Interventional2012-07-31Recruiting
A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age After the Fontan Procedure [NCT02846532]Phase 3112 participants (Actual)Interventional2016-11-16Completed
RIVA-DM: Effectiveness and Safety of Rivaroxaban vs. Warfarin in Nonvalvular Atrial Fibrillation and Diabetes Mellitus: Analysis of Electronic Health Record Data [NCT04509193]116,049 participants (Actual)Observational2020-08-21Completed
Efficacy of Different Anti-Thrombotic Strategies on the Incidence of Silent Cerebral Embolism After Percutaneous Left Atrial Appendage Occlusion: a Randomized Control Trial [NCT05671276]Phase 4150 participants (Anticipated)Interventional2022-02-01Recruiting
Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing [NCT01205932]Phase 3402 participants (Actual)Interventional2010-09-30Completed
Safety and Efficacy of Vitamin K Antagonists Versus Rivaroxaban in Hemodialysis Patients With Atrial Fibrillation: a Multicenter Randomized Controlled Trial [NCT03799822]Phase 4132 participants (Actual)Interventional2017-05-01Completed
An Open-Label Study to Estimate the Effect of Multiple Doses of Erythromycin on the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects With Renal Impairment and Normal Renal Function [NCT01309438]Phase 129 participants (Actual)Interventional2011-02-28Completed
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Patients With Venous Thromboembolism. [NCT03129555]Phase 45,000 participants (Anticipated)Interventional2023-04-01Recruiting
The Danish Non-vitamin K Antagonist Oral Anticoagulation Study. A Cluster Randomized Study Comparing Safety and Efficacy of Edoxaban, Apixaban, Rivaroxaban and Dabigatran for Oral Anticoagulation in Atrial Fibrillation (DANNOAC-AF). [NCT03129490]Phase 411,000 participants (Anticipated)Interventional2023-04-01Recruiting
Rivaroxaban Plus Aspirin Versus Acenocoumarol to Manage Recurrent Venous Thromboembolic Events Despite Systemic Anticoagulation With Rivaroxaban [NCT05515120]Phase 2/Phase 358 participants (Actual)Interventional2021-01-03Completed
The VICTORIA Study (Vascular CalcIfiCation and sTiffness Induced by ORal antIcoAgulation) Comparison Anti-vitamin K Versus Anti-Xa. [NCT02161965]Phase 451 participants (Actual)Interventional2013-05-21Completed
A Randomized Controlled Trial of Dual Antiplatelet Therapy Versus Antiplatelet Monotherapy and Oral Anticoagulation in Patients With Acute Coronary Syndrome and Coronary Artery Ectasia: OVER-TIME [NCT05233124]Phase 260 participants (Anticipated)Interventional2021-09-01Recruiting
A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Practice in Sweden [NCT02468102]99,999 participants (Actual)Observational2015-06-15Completed
Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism [NCT02555878]Phase 3841 participants (Actual)Interventional2015-09-11Completed
Xarelto® on Prevention of Stroke and Noncentral Nervous System systeMIc Embolism in Treatment Naïve Asian Patients With Non-valvular Atrial Fibrillation [NCT03284762]1,216 participants (Actual)Observational2017-09-11Completed
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis [NCT03193502]Phase 340 participants (Anticipated)Interventional2014-05-01Recruiting
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction [NCT05744804]150 participants (Anticipated)Interventional2023-03-01Not yet recruiting
Association Between Socioeconomic Factors and Use of Direct Oral Anticoagulants Versus Standard of Care (Warfarin) in Patients With Non-valvular Atrial Fibrillation in Sweden [NCT03684395]68,056 participants (Actual)Observational2016-06-15Completed
Development of Precision Medicine Platform for Pharmacogenomics of Novel Oral Anticoagulants (NOACs) [NCT04056143]500 participants (Anticipated)Observational2019-01-02Recruiting
Left Atrial Appendage CLOSURE in Patients With Atrial Fibrillation at High Risk of Stroke and Bleeding Compared to Medical Therapy: a Prospective Randomized Clinical Trial [NCT03463317]Phase 41,512 participants (Anticipated)Interventional2018-02-28Recruiting
Rivaroxaban in Patients With Atrial Fibrillation and Coronary Artery Disease Undergoing Percutaneous Coronary Intervention [NCT02334254]Phase 4420 participants (Anticipated)Interventional2013-08-31Recruiting
Comparison of Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran in Patients With Non-valvular Atrial Fibrillation (RIVAL-AF Study) -Multicenter Randomized Study- [NCT02331602]Phase 4200 participants (Anticipated)Interventional2013-07-31Recruiting
SIFNOS STUDY: RETROSPECTIVE STUDY IN PATIENTS WITH ATRIAL FIBRILLATION (AF) EXPOSED AND UNEXPOSED TO AN ORAL ANTICOAGULANT THERAPY BETWEEN 2014-2020 IN FRANCE [NCT05838664]1 participants (Anticipated)Observational2023-07-07Active, not recruiting
Anticoagulant Treatment Patterns and Outcomes Among Non-valvular Atrial Fibrillation Patients With High Risk of Gastrointestinal Bleeding in France: a Retrospective Cohort Analysis Using SNDS Database [NCT05038228]1 participants (Actual)Observational2022-08-01Active, not recruiting
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin in Patients With Atrial Fibrillation and Mitral Stenosis Among Pakistani Population [NCT03673605]Phase 40 participants (Actual)Interventional2016-12-30Withdrawn(stopped due to No patients Enrollment)
Phase 2 Placebo-Controlled, Single-Site, Single-Blind Study of Rivaroxaban Reversal by Ciraparantag as Measured by WBCT [NCT03172910]Phase 269 participants (Actual)Interventional2017-05-08Completed
Aspirin Plus Rivaroxaban Efficacy and Safety in Embolic Stroke of Undetermined Source: A Randomized, Placebo Controlled, Outcome Assessor Blind, Feasibility Study [NCT04273516]Phase 2/Phase 342 participants (Actual)Interventional2020-08-22Completed
Reveal Transition: Rivaroxaban-Evaluation of Variables Enhancing Antithrombotic Efficacy and Longterm-Outcome in Stabilized Patients With Cardiovascular Disease. A Mechanistic Study in Transition / Stabilized Phase of CAD [NCT04032665]0 participants (Actual)Observational2019-07-23Withdrawn(stopped due to study design reconsidered)
Evaluation of Chemoprophylaxis With Rivaroxaban for Lower Limb Deep Vein Thrombosis in the Surgical Treatment of Colorectal Cancer [NCT05303818]Phase 468 participants (Anticipated)Interventional2022-06-01Not yet recruiting
Rivaroxaban Once Daily Versus Dose-adjusted Vitamin K Antagonist on the Biomarkers in Acute Decompensated Heart Failure and Atrial Fibrillation (ROAD HF-AF) [NCT03490994]Phase 4150 participants (Anticipated)Interventional2018-04-10Recruiting
Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies [NCT03605433]Phase 3100 participants (Anticipated)Interventional2018-12-01Not yet recruiting
Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rivaroxaban From Repatoxaban 10 mg Tablets (Horus for Pharmaceutical Industries, Egypt) and Xarelto® 10 mg Tablets (Janssen Pharm., Licensed From: B [NCT03071380]Phase 124 participants (Actual)Interventional2015-02-28Completed
Effect of Endovascular Thrombectomy for Femoral Popliteal Vein Thrombosis on Venous Valve Function Maintenance: a Single-center, Single-arm Prospective Observational Study [NCT05588284]100 participants (Anticipated)Interventional2022-06-06Enrolling by invitation
Synergistic Influence of Rivaroxaban on Inflammation and Coagulation Biomarkers in Patients With CAD and PAD on Aspirin Therapy [NCT04059679]Phase 430 participants (Anticipated)Interventional2020-01-30Recruiting
Safety and Efficacy of Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk (HBR) Patients With History of Paroxysmal Atrial Fibrillation [NCT04151680]100 participants (Anticipated)Observational [Patient Registry]2019-12-01Recruiting
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon [NCT03563937]64,920 participants (Actual)Observational2018-06-15Completed
Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban and Apixaban in Patients With Compensated Liver Cirrhosis [NCT04874428]Phase 124 participants (Anticipated)Interventional2021-05-19Recruiting
Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism: a Multicenter Randomized Placebo-controlled Non-inferiority Trial [NCT04263038]Phase 4276 participants (Anticipated)Interventional2020-05-15Recruiting
Estimate of Costs Associated With Atrial Fibrillation Treatment With Rivaroxaban Versus Vitamin K Antagonists [NCT03462446]249 participants (Actual)Observational2015-06-01Completed
The Efficacy and Safety of Clopidogrel Combined With Rivaroxaban and Aspirin in Patients With Coronary Heart Disease and Gastrointestinal Diseases Undergoing PCI:a Randomized Controlled Study [NCT04805710]Phase 41,020 participants (Anticipated)Interventional2021-03-17Not yet recruiting
To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban [NCT03772457]400 participants (Anticipated)Observational2019-01-18Recruiting
MulticEnter Trial of Rivaroxaban for Early disCharge of pUlmonaRY Embolism From the Emergency Department [NCT02584660]Phase 4114 participants (Actual)Interventional2015-10-15Completed
Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation [NCT03374540]78,517 participants (Actual)Observational2017-12-01Completed
Evaluation of Clinical Outcomes Among Non-valvular Atrial Fibrillation Patients With Renal Dysfunction Treated With Warfarin or Reduced Dose Rivaroxaban [NCT03359876]16,000 participants (Actual)Observational2017-12-01Completed
[NCT02309970]90 participants (Anticipated)Observational2014-12-31Not yet recruiting
Observational and Cross-sectional Study to Assess the Sociodemographic and Clinical Characteristics of Patients Treated With RIVAROXABAN in the Context of Routine Clinical Practice of Spanish Haematologists, Cardiologists and Internists (HEROIC Study) [NCT02262676]2,251 participants (Actual)Observational2014-10-31Completed
Xarelto® on Prevention of Stroke and Non-Central Nervous Systemic (CNS) Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (NVAF) [NCT03746301]924 participants (Actual)Observational2018-12-03Completed
A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS). [NCT01776424]Phase 327,395 participants (Actual)Interventional2013-02-28Completed
RENal Outcomes of Rivaroxaban Compared With Warfarin in Asian patienTs With nOn-valvular atRial Fibrillation: a Nationwide Population-based Study [NCT05022758]45,000 participants (Actual)Observational2021-10-06Completed
Novel Oral Anticoagulants in Oral and Maxillofacial Surgery: Impact on Bleeding Tendency, Surgical Difficulty and Post-operative Complications [NCT04662515]300 participants (Anticipated)Observational2016-06-01Recruiting
Trial of New Oral Anticoagulants vs. Warfarin for Post Cardiac Surgery Atrial Fibrillation [NCT03702582]Phase 3100 participants (Actual)Interventional2019-04-30Completed
A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects [NCT03083704]Phase 1153 participants (Actual)Interventional2017-02-26Completed
A Multicenter, RandomiZed, Active-ControLled Study to Evaluate the Safety and Tolerability of Two Blinded Doses of Abelacimab (MAA868) Compared With Open-Label Rivaroxaban in Patients With Atrial Fibrillation (AZALEA) [NCT04755283]Phase 21,200 participants (Anticipated)Interventional2021-02-02Active, not recruiting
Randomized Trial to Test the Effect of Rivaroxaban or Apixaban on Menstrual Blood Loss in Women [NCT02829957]Phase 2/Phase 319 participants (Actual)Interventional2016-09-30Completed
Blinded Randomized Trial of Anticoagulation to Prevent Ischemic Stroke and Neurocognitive Impairment in AF (BRAIN-AF) [NCT02387229]Phase 31,238 participants (Actual)Interventional2015-03-31Terminated(stopped due to Consensus BRAIN-AF Executive Steering Committee to terminate.)
DUAL Pathway Inhibition (Low-dose Rivaroxaban and Aspirin) as Compared to Aspirin Only to Improve Endothelial Function in Peripheral Artery Disease. [NCT04218656]Phase 4159 participants (Actual)Interventional2020-06-08Completed
A Post-marketing Retrospective Non-interventional Study Using Nationwide Registries and Electronic Medical Records to Investigate the Real-life Effectiveness and Major Bleeding Complications of Oral Anticoagulants in Norwegian Non-valvular Atrial Fibrilla [NCT03715725]70,000 participants (Actual)Observational2018-10-31Terminated(stopped due to After feasibility assessment and due to delays in data receipt study was terminated)
Pharmacodynamic Effects of Low-dose Rivaroxaban in Combination With Antiplatelet Therapies in Patients With Coronary and Peripheral Artery Disease Manifestations [NCT03718429]Phase 486 participants (Actual)Interventional2019-01-14Completed
Efficacy and Safety of Anticoagulant on Early Prevention of Post-STEMI Left Ventricular Thrombus: an Open, Prospective, Randomized and Multi-centers Trial. [NCT03786757]Phase 3200 participants (Anticipated)Interventional2019-04-01Not yet recruiting
A Randomized Clinical Trial to Validate Novel Biomarker Approaches After Single Doses of Anticoagulants in Healthy Young Male Subjects and in Healthy Elderly Subjects [NCT01379300]Phase 142 participants (Actual)Interventional2011-05-31Completed
Rivaroxaban or Placebo for Extended Antithrombotic Prophylaxis After Laparoscopic Surgery for Colorectal Cancer: a Randomized, Double Blind, Placebo-controlled Study. [NCT03055026]Phase 3582 participants (Actual)Interventional2017-05-03Completed
Xarelto® for Real Life Anticoagulation in Pulmonary Embolism (PE) in China [NCT03410706]288 participants (Actual)Observational2018-02-01Completed
Special Drug Use Investigation of Xarelto for VTE [NCT02558465]2,540 participants (Actual)Observational2015-11-13Completed
Prospective, Multi-center, Randomized, Heparin-controlled Dose-finding Trial to Evaluate the Efficacy and Safety of Rivaroxaban, a Direct Factor Xa Inhibitor, on the Background of Standard Dual Antiplatelet Therapy to Support Elective Percutaneous Coronar [NCT01442792]Phase 2108 participants (Actual)Interventional2011-10-12Completed
Xarelto for Thromboprophylaxis After Total Hip and Total Knee Arthroplasty [NCT05449327]178 participants (Anticipated)Interventional2023-02-01Recruiting
THromboprophylaxis In Sickle Cell Disease With Central Venous Catheters (THIS): A Pilot Study [NCT05033314]Phase 350 participants (Anticipated)Interventional2022-06-07Recruiting
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial) [NCT02744092]811 participants (Actual)Interventional2016-12-13Completed
A Descriptive Non-interventional Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice for Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation [NCT05262322]234 participants (Actual)Observational2019-02-15Completed
Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Focus on Cost-effective Analysis and Safety Comparison Between Rivaroxaban and Enoxaparin [NCT03299296]Phase 3100 participants (Actual)Interventional2017-01-01Enrolling by invitation
Single Intravenous Administration of TB-402 for the Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery: A Phase 2b, Multicentre, Randomised, Active-Controlled, Double Blind, Double Dummy, Parallel Group Study [NCT01344954]Phase 2632 participants (Actual)Interventional2011-04-30Completed
Multicenter, Randomized, Non-inferiority Trial to Evaluate the Safety and Efficacy of Rivaroxaban Compared to Warfarin for Thromboprophylaxis in Children With Giant Coronary Aneurysms After Kawasaki Disease [NCT05643651]Phase 3332 participants (Anticipated)Interventional2023-03-01Not yet recruiting
Influence of Rivaroxaban 2.5 mg Two Times a Day for Intermittent Claudication and Exercise Tolerance in Patients With Symptomatic Peripheral Arterial Disease (PAD) - a Randomised Controlled Trial [NCT04305028]100 participants (Anticipated)Observational2021-03-10Not yet recruiting
Combination Anti-thrombotic Treatment for Prevention of Recurrent Ischemic Stroke in Intracranial Atherosclerotic Disease: Protocol for a Pilot Randomized Trial [NCT04142125]Phase 3101 participants (Actual)Interventional2020-02-03Completed
Adverse ReNal OuTcomEs in Patients With NoN-Valvular Atrial Fibrillation Treated With Rivaroxaban or Vitamin K Antagonists [NCT04297072]25,000 participants (Actual)Observational2020-05-01Completed
Comparison of Efficacy and Safety Among DAbigatran, RIvaroxaban, and ApixabaN in Patients HavinG Non-Valvular Atrial Fibrillation in Taiwan (DARING-AF Study) [NCT02666157]Phase 43,672 participants (Anticipated)Interventional2016-01-31Recruiting
Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- a Clinical Trial [NCT05973188]Phase 4141 participants (Anticipated)Interventional2023-05-01Recruiting
Randomized, Parallel-Group, 2-Part Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding Parameters and Pharmacodynamics After a Punch Biopsy Procedure in Healthy Subjects Treated With Rivaroxa [NCT02561923]Phase 1158 participants (Actual)Interventional2015-08-27Completed
Xarelto (Rivaroxaban) Risk Minimisation Plan Evaluation: Patient and Physician Knowledge of Key Safety Messages [NCT01907048]2,227 participants (Actual)Observational2014-09-15Completed
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion [NCT03630055]Phase 31,800 participants (Anticipated)Interventional2018-10-03Recruiting
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study. [NCT02611635]382 participants (Actual)Observational2016-02-02Completed
The Effect of Replacement of Vitamin K Antagonist by Rivaroxaban With or Without Vitamin K2 Supplementation on Vascular Calcifications in Chronic Hemodialysis Patients: A Randomized Controlled Trial [NCT02610933]Phase 4117 participants (Actual)Interventional2015-11-30Completed
Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects [NCT05491460]Phase 124 participants (Anticipated)Interventional2022-07-01Active, not recruiting
OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs [NCT04262492]500 participants (Anticipated)Observational [Patient Registry]2020-10-21Recruiting
Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty [NCT02379663]Phase 4639 participants (Actual)Interventional2012-01-31Completed
Rivaroxaban for Scheduled Work-up of Patients With Suspected Deep Venous Thrombosis [NCT02486445]Phase 3625 participants (Actual)Interventional2015-03-31Completed
A Pharmacodynamic Study of Rivaroxaban in Subjects Who Have Undergone Roux-en-Y Gastric Bypass Surgery [NCT02058199]Phase 12 participants (Actual)Interventional2014-12-31Terminated(stopped due to PI left the Institution; No replacement PI identified;)
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies [NCT02832531]Phase 30 participants (Actual)Interventional2022-01-31Withdrawn(stopped due to Focus on recruitment for non-inferiority trial)
Rivaroxaban vs Warfarin in Patients With Metallic Prosthesis [NCT03566303]Phase 2/Phase 350 participants (Actual)Interventional2018-07-10Terminated(stopped due to Coronavirus Pandemic)
Rivaroxaban Versus Vitamin K-Antagonist (VKA) in Thromboprophylaxis of Patients With Atrial Fibrillation: Patient Preference Study [NCT02090543]647 participants (Actual)Observational2014-01-31Completed
Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes Across the Disease Continuum in Patients With CAD and/or PAD [NCT04401761]3,189 participants (Actual)Observational2020-05-28Completed
Real-World Comparisons of Bleeding Among Novel Oral Anticoagulant (NOAC)-Naïve Non-Valvular Atrial Fibrillation (NVAF) Patients With Medicare Advantage Coverage, Who Newly Initiated Novel Oral Anticoagulation Therapies or Were Treated With Warfarin [NCT03189069]36,000 participants (Actual)Observational2016-10-06Completed
This is a Prospective, Open-label Phase 2 Pilot Study With Independent Evaluation of All Outcomes and a Historical Control Group to Determine if Rivaroxaban (Xarelto) is Feasible and Safe for Prevention of Major Complications in Patients Undergoing a Mech [NCT02128841]Phase 212 participants (Actual)Interventional2012-09-30Terminated(stopped due to not enough patients)
The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation [NCT06108414]Phase 44,306 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Randomized Controlled Clinical Trial of PARIS Coronary Thrombosis Risk Score Combined With D-dimer to Guide New Oral Anticoagulant Antithrombotic Therapy in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention [NCT05638867]Phase 43,944 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Effects of aSPIrin Versus Aspirin Plus Low-dose RIvaroxaban on Carotid aTherosclerotic Plaque Inflammation [NCT05797376]Phase 492 participants (Anticipated)Interventional2021-08-24Recruiting
THRomboprophylaxis in Individuals Undergoing Superficial endoVEnous Treatment (THRIVE) - a Multi-centre Assessor-blind Randomised-controlled Trial [NCT05735639]Phase 46,660 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Real-World, Prospective, Observational Study to Evaluate the Safety and Effectiveness of Rivaroxaban (Xarelto®) for Prevention of Stroke and Systemic Embolism in Indian Patients With Non-valvular Atrial Fibrillation (NVAF) [NCT03887780]504 participants (Actual)Observational2019-10-03Active, not recruiting
Evaluation of the Efficacy and Safety of Rivaroxaban (BAY59-7939) for the Prevention of Stroke and Non-central Nervous System Systemic Embolism in Subjects With Non-valvular Atrial Fibrillation [NCT00494871]Phase 31,280 participants (Actual)Interventional2007-06-30Completed
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study [NCT00571649]Phase 38,101 participants (Actual)Interventional2007-12-31Completed
Randomized Evaluation of Bromocriptine In Myocardial Recovery THerapy for Peripartum Cardiomyopathy (REBIRTH) [NCT05180773]Phase 4250 participants (Anticipated)Interventional2022-07-27Recruiting
Xarelto® Regulatory Post-Marketing Surveillance [NCT01029743]3,388 participants (Actual)Observational2009-12-31Completed
Single-dose, Open-label, Randomized, 4-way Crossover Study to Compare a Dry Powder Oral Suspension (10 mg and 20 mg Dose of Rivaroxaban) With an Oral Suspension (10 mg of Rivaroxaban) and 10 mg of an Immediate Release Tablet Under Fasting Conditions (10 m [NCT02367027]Phase 118 participants (Actual)Interventional2015-02-28Completed
Replication Of An Early Evaluation Of 30-Day Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated With Dabigatran, Rivaroxaban, Apixaban, or Warfarin In The U.S [NCT02769078]14,201 participants (Actual)Observational2014-11-30Completed
Rivaroxaban Versus Standard of Care for Patients With Excessive Atrial Ectopy or Short Atrial Runs and High Embolism Risk [NCT05487950]Phase 4550 participants (Anticipated)Interventional2023-04-05Not yet recruiting
Finding the Optimal Dose of Rivaroxaban in Hemodialysis Patients [NCT02047006]Phase 418 participants (Actual)Interventional2013-09-30Completed
Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembol [NCT05900388]850 participants (Anticipated)Observational2024-03-26Not yet recruiting
The Efficacy and Safety of Prophylactic Anticoagulation for Catheter-related Thrombosis in Patients With Cancer and Implantable Venous Access Ports: a Prospective Multi-center Randomized Controlled Trial. [NCT04256525]Phase 41,640 participants (Anticipated)Interventional2020-05-01Recruiting
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 15 mg and a Rivaroxaban Granule 15 mg in Japanese Healthy Adult Male Subjects [NCT02537457]Phase 140 participants (Actual)Interventional2014-01-31Completed
Comparison of the Recanalization Rate and Incidence of Postthrombotic Syndrome in Patients With Lower-limb Deep Venous Thrombosis Treated With Rivaroxaban or Warfarin [NCT02704598]84 participants (Anticipated)Interventional2016-03-31Recruiting
Prophylactic vs Therapeutic Anticoagulation in Symptomatic Isolated Distal Deep Vein Thrombosis (IDENT): a Prospective, Multicenter, Single-blind, Randomized Controlled Trial [NCT04967573]Phase 3480 participants (Anticipated)Interventional2021-08-01Recruiting
Pharmacokinetics and Pharmacodynamics of Single Doses of Rivaroxaban in Obesity Patients Before and After Bariatric Surgery - The Extension Study [NCT02832947]Phase 113 participants (Actual)Interventional2016-02-29Completed
[NCT02643212]Phase 3160 participants (Anticipated)Interventional2016-05-31Recruiting
A Prospective, Multi-Center, Pilot Study to Compare the Safety and Effectiveness of WATCHMAN Left Atrial Appendage Occlusion Device With Rivaroxaban for Stroke Prevention in Patients With Atrial Fibrillation [NCT02549963]Phase 4200 participants (Anticipated)Interventional2015-10-31Not yet recruiting
Comparison of Warfarin Versus Rivaroxaban in Management of Post-myocardial Infarction Left Ventricular Thrombus in a Tertiary Cardiac Center of Nepal: a Randomized Control Study. [NCT05794399]Phase 4196 participants (Anticipated)Interventional2023-06-19Recruiting
Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy [NCT06013020]Phase 4374 participants (Anticipated)Interventional2023-08-28Recruiting
Short-Term Anticoagulation Versus Antiplatelet Therapy for Preventing Device Thrombosis Following Left Atrial Appendage Closure. The ANDES Trial [NCT03568890]Phase 4510 participants (Anticipated)Interventional2018-09-01Recruiting
Differential EFfects of Dual antIplatelet and Dual aNtithrombotic thErapy on Hemostasis in Chronic Coronary Syndrome Patients: Define CCS Study, a Prospective Randomized Crossover Clinical Trial. [NCT05116995]Phase 430 participants (Anticipated)Interventional2021-11-01Recruiting
Clinical Application Model of Direct Oral Anticoagulants (MACACOD). Comprehensive Management of ACOD From a Specialized Center in Antithrombotic Therapy and Its Area of Influence [NCT04042155]1,600 participants (Anticipated)Observational [Patient Registry]2019-07-29Recruiting
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism [NCT00440193]Phase 33,449 participants (Actual)Interventional2007-03-31Completed
Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study [NCT00439725]Phase 31,197 participants (Actual)Interventional2007-02-28Completed
A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subje [NCT00403767]Phase 314,269 participants (Actual)Interventional2006-12-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Escalation and Dose-Confirmation Study to Evaluate the Safety and Efficacy of Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Subjects With Acute Coron [NCT00402597]Phase 23,490 participants (Actual)Interventional2006-11-30Completed
Cost-effectiveness Analysis Between Two Anticoagulation Strategies for Atrial Fibrillation in the Postoperative Period of Coronary Artery Bypass Graft Surgery [NCT05300555]Phase 450 participants (Anticipated)Interventional2021-01-05Recruiting
A Phase 2, Randomized, Open Label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban Compared With Vitamin K Antagonism in Patients With Atrial Fibrillation With Bioprosthetic Mitral Valves - RIVER [NCT02303795]Phase 21,005 participants (Actual)Interventional2015-08-31Completed
Randomized, Non-blinded, Two-way Crossover Study to Establish the Bioequivalence Between a Rivaroxaban Tablet 10 mg and a Rivaroxaban Granule 10 mg in Japanese Healthy Adult Male Subjects [NCT02537405]Phase 140 participants (Actual)Interventional2014-02-28Completed
Anticoagulation for Stroke Prevention In Patients With Recent Episodes of Perioperative Atrial Fibrillation After Noncardiac Surgery - The ASPIRE-AF Trial [NCT03968393]Phase 42,800 participants (Anticipated)Interventional2019-06-14Recruiting
Special Drug Use Investigation of Xarelto [SPAF] [NCT01582737]11,310 participants (Actual)Observational2012-05-30Completed
The EINSTEIN CYP Cohort Study Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-vein Thrombosis or Pulmonary Embolism Using a Strong CYP 3A4 Inducer [NCT00786422]Phase 225 participants (Actual)Interventional2009-05-31Completed
AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study [NCT02607371]198 participants (Actual)Observational2015-08-27Completed
Burden of Ischemic Stroke and Adherence to Oral Anticoagulants in Atrial Fibrillation in the UK Primary Care [NCT04099238]3,739 participants (Actual)Observational2019-10-01Completed
Xarelto + Acetylsalicylic Acid: Treatment Patterns and Outcomes in Patients With Atherosclerosis. A Non-interventional Study [NCT03746275]5,798 participants (Actual)Observational2018-11-13Completed
An Efficacy and Safety Study of Rivaroxaban for the Prevention of Deep Vein Thrombosis in Patients With Left Iliac Vein Compression Treated With Stent Implantation (PLICTS):A Prospective Randomized Controlled Trial [NCT04067505]Phase 3224 participants (Anticipated)Interventional2020-05-18Recruiting
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism [NCT00439777]Phase 34,833 participants (Actual)Interventional2007-03-31Completed
Recanalization Rate of Acute Deep Venous Thrombosis Related to Therapeutic Modality- Comparative Study; New Oral Anticoagulants (NOACs) Vs. Conventional Treatment. [NCT06145269]Early Phase 1100 participants (Anticipated)Interventional2023-12-01Not yet recruiting
Efficacy of Rivaroxaban in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: An Open Label Randomized Control Trial [NCT04970576]Phase 4320 participants (Anticipated)Interventional2021-06-25Recruiting
Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease Study (AFIRE Study) [NCT02642419]Phase 42,200 participants (Anticipated)Interventional2015-01-31Recruiting
Treatment of Portal, Mesenteric, and Splenic Vein Thrombosis With Rivaroxaban. A Pilot, Prospective Cohort Study [NCT02627053]Phase 3100 participants (Anticipated)Interventional2015-12-31Recruiting
Xarelto Evidence in Real Life of Patients Preference and Satisfaction Study. [NCT02876718]253 participants (Actual)Observational2016-08-11Completed
ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial. [NCT00839163]Phase 2613 participants (Actual)Interventional2004-03-31Completed
Satisfaction and Quality of Life in Patients With a Diagnosis of Non Valvular Atrial Fibrillation Who Take Rivaroxaban for Stroke Prevention [NCT01805531]411 participants (Actual)Observational2013-04-30Completed
Effect of Activated Charcoal on Rivaroxaban Pharmacokinetics in Healthy Subjects : RICHAR Study [NCT02657512]Phase 112 participants (Actual)Interventional2016-01-31Completed
A Phase 2-3, Multi-Center, Randomized Trial to Study the Potential Benefit of Factor Xa Inhibitor (Rivaroxaban) Versus Standard of Care Low Molecular Weight Heparin (Lovenox) in Hospitalized Patients With COVID-19 (XACT) [NCT04640181]Phase 2150 participants (Actual)Interventional2020-12-01Completed
Real-world Comparative Effectiveness of Rivaroxaban Versus Low-molecular-weight Heparin (LMWH) and Phenprocoumon for the Treatment and Secondary Prevention of Venous Thromboembolism (RECENT) [NCT04444804]22,153 participants (Actual)Observational2020-07-31Completed
An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover, Phase 1 Study Under Fed State to Evaluate the Safety and Pharmacokinetics of AD-109 in Healthy Male Volunteers [NCT05128591]Phase 138 participants (Actual)Interventional2021-11-09Completed
Efficacy and Safety of Apixaban in COVID-19 Coagulopathy Patients With Respiratory Severity Under Critical [NCT05088928]Phase 240 participants (Anticipated)Interventional2022-03-01Not yet recruiting
An Open-Label, Non-Randomized, Sequential Two-Treatment Period Study to Explore the Pharmacodynamic Changes When Transitioning From Rivaroxaban to Warfarin [NCT01400646]Phase 146 participants (Actual)Interventional2011-10-31Completed
CONKO_011/ AIO-SUP-0115/Ass.: Rivaroxaban in the Treatment of Venous Thromboembolism (VTE) in Cancer Patients - a Randomized Phase III Study [NCT02583191]Phase 3246 participants (Actual)Interventional2016-03-23Terminated(stopped due to Recruitment was not as expected.)
Effectiveness of Combined Anticoagulation and Antithrombotic Therapy vs Antithrombotic Therapy Alone After Lower Extremity Revascularization for Peripheral Arterial Disease [NCT04994223]Early Phase 160 participants (Anticipated)Interventional2021-07-02Recruiting
BAY59-7939, Japanese Phase II in Atrial FibrillationTrial Status [NCT00779064]Phase 236 participants (Actual)Interventional2004-07-31Completed
APIXABAN in the Prevention of Stroke and Systemic Embolism in Patients With Atrial Fibrillation in Real-Life Setting in France SNIIRAM Study [NCT02640222]321,501 participants (Actual)Observational2014-01-01Completed
Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial [NCT05705089]Phase 350 participants (Actual)Interventional2020-07-30Completed
Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study [NCT02784717]3,055 participants (Actual)Observational2016-05-11Completed
Efficacy and Safety of Oral Rivaroxaban for the Treatment of Venous Thromboembolism in Patients With Active Cancer. A Pilot Study. [NCT02746185]Phase 3159 participants (Actual)Interventional2016-09-30Completed
Anticoagulation Using Rivaroxaban on Top of Aspirin in Recent Stroke/Transient Ischemic Attack Patients With Intracranial Atherosclerotic Stenosis (AA-ICAS) [NCT05700266]Phase 2/Phase 31,180 participants (Anticipated)Interventional2023-12-30Not yet recruiting
Left Atrial Appendage Occlusion Versus Novel Oral Anticoagulation for Stroke Prevention in Atrial Fibrillation. A Multicenter Randomized Clinical Trial. (Occlusion-AF) [NCT03642509]750 participants (Anticipated)Interventional2019-01-01Recruiting
The Comparative Effectiveness of Warfarin and New Oral Anticoagulants for the Extended Treatment of Venous Thromboembolism [NCT03292666]39,603 participants (Actual)Observational2010-01-01Completed
A Prospective, Non-interventional, Multicenter Observational Study to Evaluate the Effectiveness and Safety of Rivaroxaban in Elderly NVAF Patients With or Without Renal Impairment [NCT04096547]1,200 participants (Anticipated)Observational2019-09-25Recruiting
Xarelto® for the Prevention of Stroke and Noncentral Nervous Systemic Embolism in Non-valvular Atrial Fibrillation With REnal Impairment in Taiwanese Population. [NCT04356989]493 participants (Actual)Observational2020-05-13Completed
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery of Hip or Knee [NCT00831714]19,076 participants (Actual)Observational2009-02-28Completed
Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction [NCT05077683]Phase 3560 participants (Anticipated)Interventional2021-10-18Active, not recruiting
Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial [NCT00839826]Phase 2641 participants (Actual)Interventional2002-12-31Completed
BAY 59-7939 (Factor Xa Inhibitor) Phase II Once Daily Dose Study in Patients With Atrial Fibrillation [NCT00973245]Phase 2102 participants (Actual)Interventional2006-07-31Completed
BAY 59-7939 (Factor Xa Inhibitor) Phase II Low Dose Study in Patients With Atrial Fibrillation [NCT00973323]Phase 2100 participants (Actual)Interventional2005-09-30Completed
Rivaroxaban in Type 2 Myocardial Infarctions: A Feasibility, Placebo-controlled, Double-blinded, Randomized Controlled Trial [NCT04838808]Phase 2/Phase 38 participants (Actual)Interventional2021-04-05Completed
Outcomes of Rivaroxaban and Aspirin in Patients With Lower Extremity Peripheral Arterial Disease After Endovascular Revascularization. [NCT05308030]Early Phase 1100 participants (Anticipated)Interventional2022-08-01Not yet recruiting
Efficacy and Safety of Non-vitamin K Oral Anticoagulants and Vitamin K Oral Anticoagulants on Some Metabolic and Coagulation Parameters in Diabetic and Nondiabetic Patients With First Diagnosis of Non-valvular Atrial Fibrillation [NCT02935855]Phase 4300 participants (Actual)Interventional2015-09-30Completed
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study [NCT02286414]159 participants (Actual)Observational2015-02-28Completed
RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement [NCT00362232]Phase 33,148 participants (Actual)Interventional2006-06-30Completed
Unveiling Prognosis Cancer-Associated Thromboembolism Biomarkers and Their Related Polymorphisms: Exploring Their Involvement With Immune Circulating Cells and Therapeutic Reversibility [NCT06065592]Phase 1500 participants (Anticipated)Interventional2019-02-01Recruiting
COmparison of Bleeding Risk Between Rivaroxaban and Apixaban in Patients With Atrial Fibrillation [NCT04642430]Phase 43,018 participants (Anticipated)Interventional2021-07-06Recruiting
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism [NCT03266783]Phase 42,760 participants (Anticipated)Interventional2017-12-13Recruiting
Chronic Anticoagulation in End-stage Renal Disease Patients: Pharmacokinetics and Pharmacodynamic of a Reduced Dose Regimen of Rivaroxaban [NCT05410275]Phase 310 participants (Anticipated)Interventional2022-12-01Not yet recruiting
Prediction of the COBRRA VTE Anticoagulant Trial in Healthcare Claims Data [NCT05264168]41,875 participants (Actual)Observational2021-05-03Completed
A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in Germany [NCT01947959]665,533 participants (Actual)Observational2011-12-22Completed
A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the Netherlands. [NCT01947985]208,958 participants (Actual)Observational2012-02-01Completed
A Pharmacoepidemiological Study of Rivaroxaban Use and Potential Adverse Outcomes in Routine Clinical Pratice in the United Kingdom. [NCT01947998]50,299 participants (Actual)Observational2011-12-22Completed
A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Sequential Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GCC-4401C in Healthy Males [NCT01954238]Phase 146 participants (Actual)Interventional2013-08-31Completed
An Efficacy and Safety Study of Ribaroxaban for the Prevention of Deep Vein Thrombosis Recurrence in Patients With Acute Iliofemoral Venous Thrombosis Initially Treated With Thrombolysis [NCT01986192]72 participants (Anticipated)Interventional2013-11-30Recruiting
Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of 10 mg Granules for Oral Suspension Rivaroxaban Versus 10 mg Tablets Rivaroxaban Under Fasted Condition in Healthy Subjects [NCT04720092]Phase 130 participants (Actual)Interventional2017-07-05Completed
Prospective, Multicenter Study Investigating Efficacy and Safety of Oral Rivaroxaban for the Prevention of Recurrent Venous Thromboembolism in Korean Patients With Cancers [NCT01989845]Phase 4127 participants (Actual)Interventional2013-10-31Completed
COMParison of the EffecT of mEdication Therapy: Anticoagulation Versus Anti-platelet Versus Migraine Therapy in Alleviating Migraine With Patent Foramen Ovale [NCT05546320]Phase 41,000 participants (Anticipated)Interventional2022-10-15Recruiting
Closure of Patent Foramen Ovale or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence [NCT00562289]Phase 3664 participants (Actual)Interventional2007-12-31Completed
Rivaroxaban Compared to Warfarin for Treatment of Cerebral Venous Thrombosis: a Randomized Controlled Trial [NCT04569279]Phase 371 participants (Actual)Interventional2017-09-01Completed
Randomized Controlled Study on the Prophylaxis of Venous Thromboembolic Events in Patients Undergoing Total Knee Arthroplasty: Comparison of Aspirin and Rivaroxaban [NCT02271399]Phase 2156 participants (Actual)Interventional2014-10-31Completed
Prospective, Multi-centre, Randomized, Parallel Comparison to Evaluate the Safety and Efficacy of the Abluminal Sirolimus Coated Bio-engineered Stent (COMBO Stent) in Association With Short-term Single Antiplatelet Therapy in Patients With Coronary Artery [NCT02723981]Phase 40 participants (Actual)Interventional2016-04-30Withdrawn(stopped due to Regulatory authority approval for the initial study design could not be obtained)
Italian Registry In the Setting of AF Ablation With Rivaroxaban [NCT04315974]250 participants (Anticipated)Observational [Patient Registry]2020-05-15Recruiting
Rivaroxaban for the Treatment of Symptomatic Isolated Distal Deep Vein Thrombosis [NCT02722447]Phase 31,100 participants (Anticipated)Interventional2017-01-31Recruiting
Tinzaparin Lead-In to Prevent the Post-Thrombotic Syndrome Phase IV Pilot Study [NCT04794569]Phase 460 participants (Anticipated)Interventional2021-11-15Recruiting
Patient Adherence to Venous Thromboembolism Prophylaxis in Orthopaedic Trauma Patients: A Randomized, Controlled Trial Comparing Subcutaneous Enoxaparin & Oral Rivaroxaban [NCT04169269]Phase 4128 participants (Anticipated)Interventional2020-01-13Recruiting
A Open-Label Study of the Transition to Rivaroxaban From Low-Molecular Weight Heparin for Venous Thromboembolism Prophylaxis After Total Joint Replacement: The Safe Simple Transitions Study [NCT01094886]Phase 356 participants (Actual)Interventional2010-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome [NCT00809965]Phase 315,526 participants (Actual)Interventional2008-11-30Completed
The Comparative Safety of Direct Oral Anticoagulants Versus Warfarin for the Treatment of Venous Thromboembolism [NCT02833987]59,525 participants (Actual)Observational2015-03-31Completed
Trained Immunity by Dual-pathway Inhibition (Low-dose Rivaroxaban and Acetylsalicylic Acid) in Coronary Artery Disease' [NCT05210725]Phase 420 participants (Actual)Interventional2022-03-01Active, not recruiting
Real-world Comparative Effectiveness of Rivaroxaban Versus VKA [NCT02690155]38,831 participants (Actual)Observational2016-02-12Completed
Oral Anticoagulant Bleeding Rate and Discontinuation and Adherence Patterns in Non-Valvular Atrial Fibrillation (NVAF) Patients [NCT02792335]28,000 participants (Actual)Observational2012-01-31Completed
Evaluation of the Potential Action of Coagulation Factors Concentrates in the Reversal of the Antithrombotic Action of New Oral Anticoagulants: Studies ex Vivo in Blood Samples From Healthy Volunteers [NCT01478282]Phase 410 participants (Anticipated)Interventional2012-01-31Recruiting
A Randomized Pilot Study Comparing the Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery [NCT01431456]Phase 3148 participants (Actual)Interventional2013-09-30Completed
INVestIgation of rheumatiC AF Treatment Using Vitamin K Antagonists, Rivaroxaban or Aspirin Studies [NCT02832544]Phase 34,565 participants (Actual)Interventional2016-08-22Completed
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis (CAPTIVA) [NCT05047172]Phase 31,683 participants (Anticipated)Interventional2022-08-02Recruiting
Prospective, National, Multicentric, Observational Study to Evaluate the Safety, Efficacy and Quality of Life of Patients With Atrial Fibrillation, Treated With Trombix® (Rivaroxaban). [NCT06184204]400 participants (Anticipated)Observational2023-12-31Recruiting
Single-dose, Open-label, Randomized, 4-way Crossover Study to Compare 10 mg of an Oral Suspension of Rivaroxaban Under Fasting (2 Different Batches) and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Table [NCT01853800]Phase 114 participants (Actual)Interventional2013-05-31Completed
Belgian Real Life Non-interventional Study (NIS) in Patients Treated With Xarelto® Following an Acute Deep Vein Thrombosis (DVT) [NCT01855100]131 participants (Actual)Observational2013-07-31Completed
Belgian Real Life Non-interventional Study (NIS) on Xarelto® in Non-valvular Atrial Fibrillation (AF) Patients Treated for the Prevention of Stroke and Systemic Embolism (BOX-AF) [NCT01855139]106 participants (Actual)Observational2013-07-31Completed
Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation Using Healthcare Data for Pragmatic Research: A Randomised Controlled Trial [NCT04700826]Phase 43,000 participants (Anticipated)Interventional2021-06-01Recruiting
Evaluation of Plasma Modifications Associated With Rivaroxaban® Treatment for Stroke Prevention in Patients With Atrial Fibrillation [NCT02273700]5 participants (Actual)Observational2015-11-30Completed
Randomized, Non-blinded, Two-way Crossover Study to Assess Bioequivalence Between a Rivaroxaban 15 mg Orally Disintegrating Tablet Administered With Water or Without Water and a Rivaroxaban 15 mg Film-coated Tablet in Japanese Healthy Male Adult Subjects [NCT04511637]Phase 180 participants (Actual)Interventional2019-01-21Completed
Rivaroxaban Versus Acenocumarol for Secondary Thromboprophylaxis in Patients With Antiphospholipid Syndrome: a Randomized, Prospective, Phase III Study. Analysis of Stratification Prognostic Factors [NCT02926170]Phase 3190 participants (Actual)Interventional2013-03-13Completed
Start or STop Anticoagulants Randomised Trial (SoSTART) After Spontaneous Intracranial Haemorrhage [NCT03153150]Phase 3203 participants (Actual)Interventional2018-03-28Completed
Rivaroxaban and Aspirin Versus Aspirin Alone in Preventing Atherothrombotic Events in Patients Following Coronary Artery Bypass Graft Surgery [NCT06019741]Phase 4234 participants (Actual)Interventional2021-02-01Completed
Effect of Prophylactic and Therapeutic Anticoagulants in Egyptian Patients With COVID-19 [NCT04736901]90 participants (Actual)Observational2020-12-01Completed
Pharmacokinetics and Pharmacodynamics of rivAroxaban After Bariatric Surgery and in mORBid Obesity [NCT04180436]Phase 167 participants (Actual)Interventional2020-01-15Completed
The Impact of Factor Xa Inhibition on Thrombosis, Platelet Activation, and Endothelial Function in Peripheral Artery Disease [NCT05009862]Phase 475 participants (Anticipated)Interventional2022-04-19Recruiting
Evaluation of Thromboembolic Events in Patients With Bileaflet Mechanical Valves in Mitral Position Before and After Rivaroxaban Use: RMV Study [NCT02894307]0 participants Expanded AccessNo longer available
An Open-label, International, Multicenter, Interventional Study Exploring the Efficacy of Once-daily Oral Rivaroxaban (BAY 59-7939) for the Treatment of Left Atrial/Left Atrial Appendage Thrombus in Subjects With Nonvalvular Atrial Fibrillation or Atrial [NCT01839357]Phase 360 participants (Actual)Interventional2013-08-31Completed
Prospective Multicenter Observational Non-interventional Local Study on Prescription Behavior of Anticoagulation Therapy in Secondary Stroke Prevention in Atrial Fibrillation Patients [NCT01925755]209 participants (Actual)Observational2013-07-31Completed
A Multicenter, Open-label, Prospective, Randomized, Active-controlled Study on the Efficacy and Safety of Oral Rivaroxaban Versus Enoxaparin for Venous Thromboembolism Prophylaxis After Major Gynecological Cancer Surgery. [NCT04999176]Phase 3440 participants (Anticipated)Interventional2020-10-22Recruiting
Safety and Effectiveness Study Comparing Dabigatran, Rivaroxaban & Apixaban in Non-valvular Atrial Fibrillation Patients Enrolled in the US Department of Defense Military Health System [NCT03026556]42,534 participants (Actual)Observational2016-12-29Completed
PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF) [NCT03996772]Phase 3350 participants (Anticipated)Interventional2019-06-03Recruiting
RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement. [NCT00332020]Phase 32,457 participants (Actual)Interventional2006-02-28Completed
Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-P [NCT04006288]Phase 490 participants (Actual)Interventional2019-09-06Completed
Assessment of Dual Antiplatelet Therapy Versus Rivaroxaban In Atrial Fibrillation Patients Treated With Left Atrial Appendage Closure: The Randomized ADRIFT Study [NCT03273322]Phase 2/Phase 3105 participants (Actual)Interventional2017-09-13Completed
Single-dose, Open-label, Randomized, 2-way Crossover Bioequivalence Study of 20 mg Granules for Oral Suspension Rivaroxaban Versus 20 mg Tablets Rivaroxaban Under Fed Condition in Healthy Subjects [NCT04727021]Phase 130 participants (Actual)Interventional2017-07-04Completed
Randomized, Non-blinded, Two-way Crossover Study to Assess Bioequivalence Between a Rivaroxaban 10 mg Orally Disintegrating Tablet Administered With Water or Without Water and a Rivaroxaban 10 mg Film-coated Tablet in Japanese Healthy Male Adult Subjects [NCT04511611]Phase 180 participants (Actual)Interventional2019-01-24Completed
The Dabigatran, Apixaban, Rivaroxaban, Edoxaban, Warfarin Comparative Effectiveness Research Study [NCT03271450]416,000 participants (Anticipated)Observational2017-07-01Enrolling by invitation
DEFIANCE - ClotTriever® Thrombectomy System vs. Anticoagulation Alone for Treatment of Deep Vein Thrombosis [NCT05701917]300 participants (Anticipated)Interventional2023-01-06Recruiting
Oral Anticoagulation After Cardiac Surgery in the Era of Direct Oral Anticoagulants: is Large Use of Vitamin K Antagonists Still Justified? [NCT04002011]Phase 20 participants (Actual)Interventional2022-03-09Withdrawn(stopped due to Submission process abandoned. No patient enrolled.)
Randomized Trial of Aspirin Versus Rivaroxaban After Replacement of the Aortic Valve With a Biological Valve Prosthesis [NCT02974920]Phase 41,000 participants (Anticipated)Interventional2017-01-01Recruiting
Medically Ill Hospitalized Patients for COVID-19 THrombosis Extended ProphyLaxis With Rivaroxaban ThErapy: The MICHELLE Trial [NCT04662684]Phase 3320 participants (Actual)Interventional2020-10-16Completed
Single-dose, Open-label, Randomized, 2-way Crossover Pivotal Bioequivalence Study of 2x5 mg Tablets Rivaroxaban Versus 1x10 mg Tablet Rivaroxaban Under Fasted Condition in Healthy Subjects [NCT01436526]Phase 128 participants (Actual)Interventional2009-08-31Completed
[NCT00402467]Phase 2613 participants (Actual)Interventional2004-02-29Completed
Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis [NCT01516814]Phase 340 participants (Actual)Interventional2012-02-29Completed
Randomized, Open-label (Double Blind Among Rivaroxaban Groups in the Initial 3 Weeks), Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis Without Symptomatic Pulmonary Embolism [NCT01516840]Phase 360 participants (Actual)Interventional2012-03-31Completed
Xarelto in the Prophylaxis of Post Surgical Venous Thromboembolism After Elective Major Orthopedic Surgery or Hip or Knee in Indian Patients [NCT01523418]0 participants (Actual)Observational2014-10-31Withdrawn
Open-label Randomized Control Trial to Assess the Efficacy and Safety of Dual Anticoagulants i.e. Rivaroxaban Plus Aspirin and Clopidogrel Plus Aspirin in Patients Suffering From an Acute Coronary Syndrome [NCT05573958]Phase 490 participants (Anticipated)Interventional2022-10-01Not yet recruiting
Controlled, Double-Blind, Randomised, Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939 [NCT00398905]Phase 2726 participants (Actual)Interventional2004-01-31Completed
Non Inferiority Study of a Reduced Dose of Activated Charcoal on Rivaroxaban Pharmacokinetics. [NCT04767776]Phase 112 participants (Actual)Interventional2022-01-03Completed
Effectiveness and Safety of Rivaroxaban Compared With Apixaban in Cancer-Associated Venous Thromboembolism: A Head-to-Head (H2H) Analysis of the United States Cohort of the Observational Study in Cancer Associated Thrombosis for Rivaroxaban (H2H-OSCAR-US) [NCT05461807]2,437 participants (Actual)Observational2022-07-14Completed
Satisfaction and Quality of Life in Patients With a Diagnosis of DVT (Deep Venous Thrombosis) Who Take Rivaroxaban [NCT01805544]113 participants (Actual)Observational2013-05-31Completed
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation. [NCT00395772]Phase 2543 participants (Actual)Interventional2004-12-31Completed
Controlled, Double-Blind, Randomized, Dose-ranging Study of Once-daily Regimen of BAY59-7939 in the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXaHIP-OD [NCT00396786]Phase 2877 participants (Actual)Interventional2004-11-30Completed
OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial [NCT03759938]3,478 participants (Anticipated)Interventional2019-06-18Recruiting
Prospective, Non-randomized, Open-label, Mono-centric, Cohort Study on the Absorption of Oral Rivaroxaban in Patients With a Cervical Spinal Cord Injury [NCT02970773]Phase 40 participants (Actual)Interventional2017-12-04Withdrawn(stopped due to insufficient recruitment; sponsor-investigator has left the institution)
Randomized Crossover 2-Period Single-dose BE Study of Rivaroxaban Film-coated Tablets 20mg (Pharmtechnology LLC, Republic of Belarus) and Xarelto® Film-coated Tablets 20mg (Bayer AG, Germany) in Healthy Male Volunteers Under Fed Conditions [NCT04729998]Phase 134 participants (Anticipated)Interventional2021-01-30Not yet recruiting
Rivaroxaban for Improvement of Thromboembolism Outcomes in Patients With Multiple Myeloma on Lenalidomide-based Therapy: RithMM Trial [NCT03428373]Phase 2/Phase 386 participants (Anticipated)Interventional2023-07-30Recruiting
Replication of the EINSTEIN-PE Anticoagulant Trial in Healthcare Claims Data [NCT04879407]98,947 participants (Actual)Observational2020-10-10Completed
Replication of the EINSTEIN-DVT Anticoagulant Trial in Healthcare Claims Data [NCT04736420]78,605 participants (Actual)Observational2020-09-22Completed
Replication of the ROCKET-AF Anticoagulant Trial in Healthcare Claims Data [NCT04593056]102,636 participants (Actual)Observational2020-09-01Completed
Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms [NCT04192916]442 participants (Actual)Observational2019-09-01Completed
Prostate Cancer VTE in Sweden: Epidemiology and Anticoagulation Treatment of VTE [NCT03965741]97,765 participants (Actual)Observational2019-05-30Completed
Characterisation of a Novel Regimen of Very Low-dose Aspirin Combined With Rivaroxaban in Patients With Chronic Coronary Syndromes: WILL lOWer Dose Aspirin be Better With Rivaroxaban in Patients With Chronic Coronary Syndromes? [NCT04990791]Phase 448 participants (Anticipated)Interventional2021-08-26Recruiting
A Randomized Controlled Trial to Investigate Whether a Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at the Time of Device Surgery, in Patients With Moderate to High Risk of Arterial Thrombo-embolic Events, Leads to a Reduction in the [NCT01675076]Phase 3663 participants (Actual)Interventional2013-01-31Completed
THE CAPITAL PCI AF Study: The Safety and Efficacy of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention [NCT03331484]Phase 340 participants (Actual)Interventional2018-11-01Active, not recruiting
Coronary Artery Ectasia, Thrombotic Background and Efficacy of Various Anti Thrombotic Regimens. [NCT05718531]Phase 3200 participants (Anticipated)Interventional2023-02-01Not yet recruiting
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) [NCT02701062]Phase 4562 participants (Actual)Interventional2016-02-29Completed
APIXABAN DRUG UTILIZATION STUDY IN STROKE PREVENTION IN ATRIAL FIBRILLATION (SPAF) [NCT03441633]51,690 participants (Actual)Observational2016-02-18Completed
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists [NCT02960880]99,999 participants (Actual)Observational2016-10-15Completed
Real-World Comparative Observational Study in Non-Valvular Atrial Fibrillation Patients Using Oral Anticoagulants [NCT02754154]321,182 participants (Actual)Observational2014-12-31Completed
Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF: The CORRAL-AF Study [NCT04684212]2,931 participants (Anticipated)Interventional2023-12-01Not yet recruiting
RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement [NCT00329628]Phase 34,541 participants (Actual)Interventional2006-02-28Completed
Open-label, Randomized Trial of the Safety and Efficacy of Doxycycline and Rivaroxaban Therapy Versus National Standard Therapy in Ambulatory Patients With Mild Symptomatic COVID-19 [NCT04715295]Phase 4200 participants (Anticipated)Interventional2020-10-05Recruiting
An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interaction Between Tegoprazan and Novel Oral Anticoagulants (NOACs) After Multiple Oral Dosing in Healthy Volunteers [NCT05723510]Phase 187 participants (Actual)Interventional2023-03-06Completed
Xarelto® for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) [NCT01619007]5,145 participants (Actual)Observational2012-06-30Completed
Characterizing Recurrent Thromboembolism, Major Bleeding and All-Cause Death in Patients With Cancer-Associated Thromboembolism Treated With Rivaroxaban [NCT03214172]1,000 participants (Actual)Observational2017-07-15Completed
Randomized, Parallel-Group, Open-Label Study to Assess the Effects of 3-Factor and 4-Factor Prothrombin Complex Concentrates on the Pharmacodynamics of Rivaroxaban [NCT01656330]Phase 135 participants (Actual)Interventional2012-07-31Completed
An Exploratory Study of Effectiveness and Safety of Rivaroxaban in Patients With Left Ventricular Thrombus [NCT04970381]60 participants (Anticipated)Interventional2021-07-22Recruiting
A Pilot Study in Cancer Patients With Central Venous Catheter Associated Deep Vein Thrombosis in the Upper Extremity Treated With Rivaroxaban (Catheter 2) [NCT01708850]Phase 470 participants (Actual)Interventional2012-11-30Completed
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427]695 participants (Actual)Observational2012-11-30Completed
A Prospective Pharmacodynamic Study of Rivaroxaban Using Peak and Trough Coagulation Test Results in Patients on Therapeutic Doses of Rivaroxaban [NCT01743898]65 participants (Anticipated)Observational2012-10-31Completed
Anticoagulation With Rivaroxaban in Post Cardioversion Patients [NCT01747746]Phase 433 participants (Actual)Interventional2012-10-31Completed
Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Asia: A Non-interventional Study [NCT01750788]2,297 participants (Actual)Observational2013-01-13Completed
XANTUS-EL, Xarelto® on Prevention of Stroke and Noncentral Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A Non-interventional Study [NCT01800006]2,101 participants (Actual)Observational2013-01-14Completed
Thromboprophylaxis in Patients Undergoing Orthopedic Surgeries; Using Propensity Score Matching [NCT03483181]4,000 participants (Anticipated)Observational2018-01-01Recruiting
A Prospective, Randomized, Controlled, Analyst-blinded, Parallel Group Study to Investigate the Effect of Antithrombotic Triple Therapy With Ticagrelor and Acetylsalicylic Acid in Combination With Dabigatran or Rivaroxaban or Phenprocoumon on Markers of C [NCT01812200]Phase 460 participants (Actual)Interventional2012-10-31Completed
A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered VMX-C001 in Healthy Subjects (Part 1) and in Combination With Selected Dire [NCT05152420]Phase 1105 participants (Actual)Interventional2021-10-29Completed
Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux [NCT01499953]Phase 3472 participants (Actual)Interventional2012-04-30Completed
A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2) [NCT04351724]Phase 2/Phase 3500 participants (Anticipated)Interventional2020-04-16Recruiting
A Pilot Study of Using Statins in Patients With Acute Venous Thromboembolism (VTE) [NCT02331095]Early Phase 121 participants (Actual)Interventional2015-01-31Terminated(stopped due to Low recruitment)
A Phase 2, Open Label, Pilot Study to Examine the Use of Rivaroxaban Plus Aspirin vs. Clopidogrel Plus Aspirin for the Prevention of Restenosis After Infrainguinal Percutaneous Transluminal Angioplasty for Critical Limb Ischemia [NCT02260622]Phase 220 participants (Actual)Interventional2014-10-31Completed
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban in SwEden (OSCAR-SE) [NCT05150938]5,737 participants (Actual)Observational2022-03-18Completed
Efficacy and Safety of Vascular Boot Warming Program After Acute DVT±PE for Earlier Resolution of Venous Thromboembolism (VTE) and Prevention of Post Thrombotic Syndrome: A Pilot Study. [NCT03465735]15 participants (Actual)Interventional2017-01-13Terminated(stopped due to Due to lack of recruitment of eligible participants)
Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement [NCT04258488]Phase 41,300 participants (Anticipated)Interventional2022-02-21Recruiting
Study of Risk Factors of Major Cardiovascular Events in Patients With Nonvalvular Atrial Fibrillation Treated With a Direct Oral Anticoagulant (Rivaroxaban) [NCT02975453]1,481 participants (Actual)Observational2016-12-05Completed
Primary Thromboprophylaxis in Patients With Malignancy and Central Venous Catheters: a Randomized Controlled Trial [NCT05029063]Phase 31,828 participants (Anticipated)Interventional2022-10-05Recruiting
The Effects of Hypothermia and Acidosis on Coagulation During Treatment With Rivaroxaban Measured With Rotational Thromboelastometry (ROTEM) [NCT05669313]15 participants (Actual)Observational2022-09-04Completed
Prospective Multicentre Non-interventional Study on Compliance and Patient/Doctor Behavior of VTE Prevention in Major Orthopedic Surgery [NCT01444586]2,293 participants (Actual)Observational2011-10-31Completed
Low-dose Rivaroxaban Monotherapy Versus Guideline Determined Medication Therapy After Left Atrial Appendage Occlusion: a Randomized, Open-label, Multicentre, Superiority Trial [NCT05960721]4,220 participants (Anticipated)Interventional2023-07-06Recruiting
Prediction of the COBRRA AF Anticoagulant Trial in Healthcare Claims Data [NCT05256797]529,536 participants (Actual)Observational2021-05-03Completed
Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data [NCT05083455]89,215 participants (Actual)Observational2020-09-22Completed
COSIMO Cancer Associated Thrombosis - Patient Reported Outcomes With Rivaroxaban. A Non-interventional Study on Patients Changing to Xarelto® for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer. [NCT02742623]528 participants (Actual)Observational2016-10-11Completed
PK Study of Oral Rivaroxaban in Healthy Subjects [NCT01464450]Phase 155 participants (Actual)Interventional2011-10-31Completed
Randomized,Double-blind Trial Comparing the Effects of a Rivaroxaban Regimen During the First 30 Days,Versus Aspirin for the Acute Treatment of TIA or Minor Stroke [NCT01923818]Phase 2/Phase 33,700 participants (Anticipated)Interventional2013-09-30Not yet recruiting
A Pilot Study Assessing the Feasibility of a Randomized Controlled Trial Investigating Primary Thromboprophylaxis With Rivaroxaban in Patients With Malignancy and Central Venous Catheters [NCT03506815]Phase 3100 participants (Actual)Interventional2019-03-15Completed
7-day Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children From Birth to Less Than 6 Months With Arterial or Venous Thrombosis [NCT02564718]Phase 1/Phase 210 participants (Actual)Interventional2015-11-19Completed
HIP Fracture Oral thromboPROphylaxis: A Pilot Randomized Controlled Trial (Hip PRO Pilot) [NCT05775965]Phase 3250 participants (Anticipated)Interventional2023-06-30Not yet recruiting
Early Rivaroxaban for Acute Ischemic Stroke or TIA Patients With Atrial Fibrillation: a Prospective, Multicenter, Cohort Study [NCT03749057]Phase 4400 participants (Anticipated)Interventional2018-11-20Recruiting
Early Versus Late Initiation of Direct Oral Anticoagulants in Post-ischaemic Stroke Patients With Atrial fibrillatioN (ELAN): an International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial [NCT03148457]2,013 participants (Actual)Interventional2017-11-06Completed
Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients With Coronavirus (COVID-19) - COALIZAO ACTION Trial [NCT04394377]Phase 4615 participants (Actual)Interventional2020-06-21Completed
Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk [NCT02111564]Phase 312,024 participants (Actual)Interventional2014-01-07Completed
Randomized Crossover 2-Period Single-dose BE Study of Rivaroxaban Film-coated Tablets 10mg (Pharmtechnology LLC, Republic of Belarus) and Xarelto® Film-coated Tablets 10mg (Bayer AG, Germany) in Healthy Male Volunteers in Fasting Conditions [NCT04753489]Phase 134 participants (Anticipated)Interventional2021-02-13Not yet recruiting
Venous Thromboembolism in Renally Impaired Patients and Direct Oral Anticoagulants [NCT02664155]Phase 3203 participants (Actual)Interventional2016-10-19Terminated(stopped due to recruiting difficulties)
The Direct Oral Anticoagulation Versus Warfarin After Cardiac Surgery Trial [NCT04284839]Phase 36,215 participants (Anticipated)Interventional2021-07-18Recruiting
[NCT02422602]196 participants (Actual)Interventional2013-11-26Completed
A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acut [NCT04508023]Phase 31,284 participants (Actual)Interventional2020-08-13Terminated(stopped due to The study was terminated prematurely due to enrollment challenges.)
Multicentric Randomized Study of Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis. [NCT02555111]Phase 3112 participants (Actual)Interventional2015-09-30Completed
A Parallel Group Study in Healthy Participants to Quantify Subclinical Gastrointestinal Blood Loss Following Administration of Aspirin Alone or Aspirin in Combination With Rivaroxaban [NCT05546957]60 participants (Actual)Interventional2023-01-05Completed
Global Multicenter, Open-label, Randomized, Event-driven, Active-controlled Study Comparing a rivAroxaban-based Antithrombotic Strategy to an antipLatelet-based Strategy After Transcatheter aortIc vaLve rEplacement (TAVR) to Optimize Clinical Outcomes [NCT02556203]Phase 31,653 participants (Actual)Interventional2015-12-16Terminated(stopped due to Imbalance in the efficacy and safety endpoints between treatment arms in favor of comparator)
Pharmacokinetics and Bioequivalence of Generic and Branded Rivaroxaban Tablet in Healthy Chinese Volunteers Under Fasting and Fed Conditions [NCT04424381]Phase 172 participants (Actual)Interventional2019-06-04Completed
Randomized, Pragmatic, Open Controlled Multicentre Study, Evaluating the Use of Rivaroxaban in Mild or Moderate COVID-19 Patients [NCT04757857]Phase 4660 participants (Actual)Interventional2020-09-29Terminated(stopped due to Sustained reduction in the number of new COVID-19 cases as well as lower than expected event rates)
Monotherapy Anticoagulation To Expedite Home Treatment of Venous [NCT03404635]1,300 participants (Actual)Observational2017-08-04Completed
Treatment Satisfaction Under Rivaroxaban (ACTS/TSQM) [NCT01598051]741 participants (Actual)Observational2012-05-31Completed
Rivaroxaban for Treatment of Patients With Suspected or Confirmed Heparin-Induced Thrombocytopenia [NCT01598168]Phase 322 participants (Actual)Interventional2013-01-31Terminated(stopped due to slow recruitment)
SafeTy and Efficacy of Direct Oral Anticoagulant Versus Aspirin for Reduction Of RisK of CErebrovascular Events in Patients Undergoing Ventricular Tachycardia Ablation (STROKE-VT) [NCT02666742]Phase 4246 participants (Actual)Interventional2017-02-16Completed
The Preventive Effect of Anticoagulants on the Formation of Thrombosis After Splenectomy in Liver Cirrhosis Patients With Portal Hypertension [NCT04397289]Phase 1/Phase 270 participants (Actual)Interventional2018-02-12Completed
VICTORIE (VTE In Cancer - Treatment, Outcomes and Resource Use In Europe) [NCT04618913]1 participants (Anticipated)Observational2020-12-14Active, not recruiting
Rivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or Without SLE (RISAPS): a Randomised, Controlled, Open-label, Phase IIb, Non-inferiority Proof of Principle Trial. [NCT03684564]Phase 243 participants (Actual)Interventional2021-07-09Active, not recruiting
Impact of Steady State Cobicistat and Darunavir/Cobicistat on the Pharmacokinetics and Pharmacodynamics of Oral Anticoagulants (Rivaroxaban, Apixaban) in Healthy Volunteers [NCT03864406]Phase 112 participants (Actual)Interventional2019-06-04Completed
A Randomized, Double-Blind, Double-Dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects With Acute Coronary Syndrom [NCT02293395]Phase 23,037 participants (Actual)Interventional2015-04-20Completed
Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), [NCT02313909]Phase 37,213 participants (Actual)Interventional2014-12-23Terminated(stopped due to Study halted early due to no efficacy improvement over aspirin at an interim analysis and very little chance of showing overall benefit if study were completed)
Rhythm Evaluation for AntiCoagulaTion With COntinuous Monitoring [NCT01706146]Phase 459 participants (Actual)Interventional2012-10-31Completed
Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy: a Randomized Double-blind Trial (ERIKA Study) [NCT01629381]Phase 2500 participants (Actual)Interventional2012-05-31Completed
XENITH: Rivaroxaban for Pulmonary Embolism Managed With Catheter Directed Thrombolysis [NCT02506985]Phase 410 participants (Actual)Interventional2015-07-31Terminated
30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Young Children With Various Manifestations of Venous Thrombosis [NCT02309411]Phase 246 participants (Actual)Interventional2015-01-15Completed
Pilot Study of Post-thrombotic Syndrome & Predictors of Recurrence in Cancer Patients With Catheter-related Thrombosis [NCT01999179]27 participants (Actual)Interventional2014-06-30Completed
A Prospective, Multicenter, Randomized Controlled Study of Postoperative Thrombosis Prevention in Patients With Cushing's Disease [NCT04486859]206 participants (Anticipated)Interventional2020-12-01Recruiting
Rivaroxaban Versus Warfarin in Acute Ischemic Stroke With Atrial Fibrillation: Acute Stroke With Xarelto to Reduce Intracranial Bleeding, Recurrent Embolic Stroke, and Hospital Stay, Phase 2, Conceptual Multicenter Trial [NCT02042534]Phase 2195 participants (Actual)Interventional2014-01-31Completed
Medical Need of Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Head Trauma, Fracture, and Emergency Surgery Using Large Scale Claims Database (Please Note That This Study Contains no Patients Treated With Idarucizumab Although the St [NCT03254147]53,969 participants (Actual)Observational2017-10-15Completed
Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Incidence of Heavy Menstrual Bleeding in Women of Reproductive Age Treated With Direct Oral Anticoagulants Because of Venous Thromboembolism [NCT04477837]150 participants (Anticipated)Observational [Patient Registry]2020-10-15Recruiting
Left Atrial Appendage Occlusion Versus Novel Oral Anti-coagulation in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention: a Randomized, Multicentre, Open-label, Non-inferiority Trial [NCT05353140]1,386 participants (Anticipated)Interventional2022-09-01Recruiting
Real-world Dosing Patterns of Rivaroxaban in the United States (RIVA-D) [NCT03242278]12,507 participants (Actual)Observational2016-02-12Completed
The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis [NCT03413618]Phase 490 participants (Actual)Interventional2017-12-20Completed
THE REAL WORLD EVIDENCE ON TREATMENT PATTERNS, EFFECTIVENESS, AND SAFETY OF DRUGS FOR STROKE PREVENTION IN NONVALVULAR ATRIAL FIBRILLATION PATIENTS IN KOREA [NCT03572972]64,684 participants (Actual)Observational2018-01-31Completed
Stroke/Systemic Embolism and Major Bleeding in Patients Newly Treated With Oral Anticoagulants: a Real World Study From Portuguese Administrative Claims Data [NCT04808934]0 participants (Actual)Observational2020-06-01Withdrawn(stopped due to Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.)
The Optimal Anticoagulation for Enhanced Risk Patients Post-Catheter Ablation for Atrial Fibrillation Trial [NCT02168829]Phase 41,284 participants (Actual)Interventional2016-01-31Active, not recruiting
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention [NCT06103266]Phase 450 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Randomized, Placebo-controlled, Parallel-group Study in Healthy Male Subjects to Investigate the Pharmacodynamics During the Switching Procedure From Warfarin to Rivaroxaban [NCT01507051]Phase 196 participants (Actual)Interventional2008-11-30Completed
Efficacy and Safety of Rivaroxaban in the Management of Acute Non-neoplastic Portal Vein Thrombosis in HCV Related Compensated Cirrhosis [NCT03201367]40 participants (Actual)Interventional2014-05-01Completed
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty [NCT04878497]1,000,000 participants (Anticipated)Observational2021-03-30Active, not recruiting
Multi-center、Randomize、Open、Non-inferiority Study of Prophylactic Effect of Rivaroxaban on Venous Thromboembolism in AECOPD [NCT03277001]438 participants (Anticipated)Interventional2017-10-01Not yet recruiting
A Pilot Trial of Restarting Direct Oral Anticoagulants After Traumatic Intracranial Hemorrhage [NCT04891861]Phase 3100 participants (Anticipated)Interventional2021-07-01Not yet recruiting
The Effect of Factor Xa Inhibition, With Rivaroxaban, on the Pathology of Sickle Cell Disease [NCT02072668]Phase 214 participants (Actual)Interventional2014-02-28Completed
A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin Versus Direct Oral Anticoagulants for Cancer-associated Venous Thromboembolism in Patients With Advanced Upper Gastrointestinal, Hepatobiliary and Pancrea [NCT03139487]Phase 2176 participants (Anticipated)Interventional2017-08-07Recruiting
Safety and Effectiveness of Rivaroxaban and Apixaban Compared to Warfarin in Non-valvular Atrial Fibrillation Patients in the Routine Clinical Practice in the UK [NCT03847181]45,164 participants (Actual)Observational2019-02-28Completed
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort [NCT04979780]3,708 participants (Actual)Observational2021-07-20Completed
Rivaroxaban Treatment Discontinuation Rates in Routine Clinical Practice in Italy in Patients With Non-valvular Atrial Fibrillation [NCT04174859]812 participants (Actual)Observational2019-12-10Completed
Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in Daily Clinical Practice - A French Cohort Within the Nationwide Claims and Hospital Database [NCT02864758]99,999 participants (Actual)Observational2016-09-08Completed
Microvascular and Antiinflammatory Effects of Rivaroxaban Compared to Low Dose Aspirin in Type-2 Diabetic Patients With Very High Cardiovascular Risk and Subclinical Inflammation [NCT02164578]Phase 3179 participants (Actual)Interventional2015-04-30Completed
A Prospective, Randomized, Open-label, Parallel-group, Active-controlled, Multicenter Study Exploring the Efficacy and Safety of Once-daily Oral Rivaroxaban (BAY59-7939) Compared With That of Dose-adjusted Oral Vitamin K Antagonists (VKA) for the Preventi [NCT01674647]Phase 31,504 participants (Actual)Interventional2012-10-31Completed
AntiCoagulation Versus AcetylSalicylic Acid After Transcatheter Aortic Valve Implantation [NCT05035277]Phase 3360 participants (Anticipated)Interventional2021-12-04Recruiting
Validation of Rivaroxaban Assay for US Registration [NCT02333929]100 participants (Actual)Observational2015-03-31Completed
Anticoagulation for Development of Further Decompensation and Survival in Advanced Cirrhosis After Transjugular Intrahepatic Portosystemic Shunt: a Multicenter Randomized Controlled Study [NCT03005444]254 participants (Anticipated)Interventional2017-06-14Recruiting
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism: The Pilot Study [NCT02559856]Phase 472 participants (Actual)Interventional2016-05-31Completed
Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement: Balancing Safety and Effectiveness [NCT02810704]Phase 420,000 participants (Anticipated)Interventional2016-12-31Recruiting
A Prospective Observational Cohort Study of Predictive Factors Related to Prognosis of In-hosiptal Patients With Ischemic Stroke Due to Large-artery Atherosclerosis [NCT04847752]1,000 participants (Anticipated)Observational2021-03-01Recruiting
Effectiveness and Safety of Low Dose Rivaroxaban Plus Aspirin in Patients With Chronic Coronary Syndrome and High Ischemic Risk [NCT04753372]645 participants (Actual)Observational [Patient Registry]2020-12-21Completed
Real-world Evidence for Non-valvular Atrial Fibrillation Patients Treated With Oral Anticoagulation in the Nordics [NCT04249401]134,897 participants (Actual)Observational2020-03-01Completed
30-day, Single-arm Study of the Safety, Efficacy and the Pharmacokinetic and Pharmacodynamic Properties of Oral Rivaroxaban in Children With Various Manifestations of Venous Thrombosis [NCT01684423]Phase 264 participants (Actual)Interventional2013-02-19Completed
Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty [NCT01720108]Phase 33,426 participants (Actual)Interventional2013-02-24Completed
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial. [NCT04333407]320 participants (Actual)Interventional2020-04-03Terminated(stopped due to Difficulty in recruiting eligible participants)
A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Diseas [NCT01877915]Phase 35,081 participants (Actual)Interventional2013-09-10Completed
A Randomized Trial of the Safety of Non-vitamin K Oral Anticoagulants Compared to Warfarin Early After Cardiac Surgery: a Pilot Study [NCT05006287]Phase 2100 participants (Anticipated)Interventional2021-10-01Not yet recruiting
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR) [NCT05399277]Phase 3700 participants (Anticipated)Interventional2023-05-17Recruiting
XALIA LEA- Xarelto for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE) in Latin America, EMEA and Asia [NCT02210819]1,987 participants (Actual)Observational2014-06-27Completed
Assessment of Anti-Coagulation Therapy on Patient With Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction [NCT05892042]320 participants (Anticipated)Interventional2023-05-01Recruiting
Effectiveness and Safety of Rivaroxaban Used in Clinical Practice of Extended Anticoagulation for Pulmonary Embolism Patients in China, XAPEC-EXT [NCT04527042]496 participants (Anticipated)Observational2020-11-30Not yet recruiting
Single-dose Study Testing Rivaroxaban Granules for Oral Suspension Formulation in Children From 2 Months to 12 Years With Previous Thrombosis [NCT02497716]Phase 147 participants (Actual)Interventional2015-11-04Completed
International Registry on the Use of the Direct Oral Anticoagulants for the Treatment of Unusual Site Venous Thromboembolism [NCT03778502]300 participants (Anticipated)Observational [Patient Registry]2019-10-01Recruiting
A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation [NCT01729871]Phase 3253 participants (Actual)Interventional2013-02-28Completed
A Randomized, Double-Blind, Vehicle-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered PRT064445 After Dosing to Steady State With One of Four Direct/Indirect fXa Inhibit [NCT03578146]Phase 248 participants (Actual)Interventional2012-12-31Completed
Xarelto® on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation [NCT01606995]6,784 participants (Actual)Observational2012-06-12Completed
Prevention of Thromboembolism With Rivaroxaban in Genitourinary Cancer Patients Receiving Systemic Therapy: A Randomized Placebo-Controlled, Double-Blind Clinical Trial [NCT05920343]Phase 2/Phase 3120 participants (Anticipated)Interventional2024-02-29Not yet recruiting
AntiCoagulants and COGnition (ACCOG Trial): a Single-blind Randomized Controlled Trial Comparing the Neurocognitive Effects of Rivaroxaban Versus Vitamin K Antagonist [NCT04073316]Phase 448 participants (Anticipated)Interventional2020-02-13Recruiting
An Efficacy and Safety Study of New Oral Anticoagulants and Vitamin K Antagonists for the Anticoagulation for the Implantation of Vena Cava Filters: A Prospective Randomized Controlled Trial [NCT04066764]Phase 3200 participants (Anticipated)Interventional2020-05-08Recruiting
An Open-label, Randomized, Controlled, Multicenter Study to Evaluate DUAL Antithrombotic Therapy With Rivaroxaban Plus Ticagrelor vs. Rivaroxaban Plus Clopidogrel in Patients With Atrial Fibrillation and Acute Coronary Syndrome [NCT04023630]Phase 44,000 participants (Anticipated)Interventional2019-10-01Not yet recruiting
An Open-label Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of a Single Dose of Rivaroxaban in Subjects With End-Stage Renal Disease (ESRD) on Maintenance Hemodialysis [NCT02289703]Phase 116 participants (Actual)Interventional2015-01-31Completed
Multicenter, Open-label, Active-controlled, Randomized Study to Evaluate the Efficacy and Safety of an age-and Body Weight-adjusted Rivaroxaban Regimen Compared to Standard of Care in Children With Acute Venous Thromboembolism [NCT02234843]Phase 3500 participants (Actual)Interventional2014-11-13Completed
Multicentre, Prospective Randomized Open Label, Blinded-endpoint (PROBE) Controlled Trial of Early Anticoagulation With Rivaroxaban Versus Standard of Care in Determining Safety at 365 Days in Symptomatic Cerebral Venous Thrombosis [NCT03178864]Phase 255 participants (Actual)Interventional2019-03-12Completed
An International, Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Trial Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Thrombotic Vascular Events in Patients With Symptomatic Peripheral Artery Disease Un [NCT02504216]Phase 36,564 participants (Actual)Interventional2015-08-18Completed
A Randomized Controlled Trial of Rivaroxaban Combined With Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone 1 Month After Drug-coated Balloon Angioplasty in Patients With Acute Coronary Syndrome Without High Bleeding Risk [NCT05750758]120 participants (Anticipated)Interventional2022-05-10Recruiting
Risk Factors of Outcomes Associated With Disease Progression in Patients With Atrial Fibrillation and Heart Failure (HF) Who Are Receiving a Direct Oral Anticoagulant (Rivaroxaban) [NCT03455439]552 participants (Actual)Observational2018-03-16Completed
Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban and Aspirin to Aspirin Alone Following Total Hip and Knee Arthroplasty (EPCATIII) [NCT04075240]Phase 35,400 participants (Anticipated)Interventional2021-02-04Recruiting
An Open-label, Randomized, Controlled, Multicenter Study Exploring Two Treatment Strategies of Rivaroxaban and a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy in Subjects With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention [NCT01830543]Phase 32,124 participants (Actual)Interventional2013-05-10Completed
Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism [NCT02064439]Phase 33,365 participants (Actual)Interventional2014-03-05Completed
A Single Center, Open Label, Randomized, Single-dose, Two Period Two Way Cross-over Study to Explore the Bioequivalence of Xaroban 20mg (Rivaroxaban) Tablet and Xarelto 20mg (Rivaroxaban) Tablet Under Fed Conditions in Healthy Male Pakistani Subjects. [NCT04689919]Phase 126 participants (Actual)Interventional2022-02-19Completed
REal-LIfe Evidence on Stroke Prevention in Patients With Atrial Fibrillation [NCT02485873]8,607 participants (Actual)Observational2015-05-31Completed
Rivaroxaban Versus Low-molecular-weight Heparin in Preventing Thrombosis Among Cancer Patients After Femoral Venepuncture [NCT03282643]Phase 1/Phase 274 participants (Actual)Interventional2016-02-16Completed
The Blood Saving Effect and Wound-related Complications of Tranexamic Acid in Mininally Invasive Total Knee Arthroplasty With Rivaroxaban as Thromboprophylaxis [NCT02458729]Phase 4294 participants (Actual)Interventional2012-08-31Completed
A Multi-center Randomized Controlled Study of High/Low-dosage Rivaroxaban Compared With DAPT After Left Atrial Appendage Occulsion in Patients With Non-valvular Atrial Fibrillation(ESCORT-AF Study(B)) [NCT04135677]Phase 4826 participants (Anticipated)Interventional2022-11-11Recruiting
Comparison of Topical and Infusion Tranexamic Acid on Blood Loss and Risk of Deep Vein Thrombosis After Total Knee Arthroplasty [NCT02453802]Phase 490 participants (Anticipated)Interventional2015-06-30Not yet recruiting
Rivaroxaban Versus Warfarin in the Evaluation of Progression of Coronary Calcium [NCT02376010]Phase 4110 participants (Actual)Interventional2015-04-02Completed
RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement. [NCT00361894]Phase 32,531 participants (Actual)Interventional2006-02-28Completed
BARIVA:Short Versus Extended Prophylaxis of Rivaroxaban for Venous Thromboembolism After Bariatric Surgery [NCT03522259]Phase 2260 participants (Anticipated)Interventional2018-07-19Active, not recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00362232 (16) [back to overview]Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.
NCT00362232 (16) [back to overview]Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE
NCT00362232 (16) [back to overview]Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.
NCT00362232 (16) [back to overview]Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.
NCT00362232 (16) [back to overview]Incidence of DVT (Proximal, Distal) Per Protocol Population.
NCT00362232 (16) [back to overview]Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.
NCT00362232 (16) [back to overview]Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.
NCT00362232 (16) [back to overview]Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.
NCT00362232 (16) [back to overview]Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population
NCT00362232 (16) [back to overview]Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.
NCT00362232 (16) [back to overview]Incidence of Symptomatic VTE During Follow-up Per Protocol Population.
NCT00362232 (16) [back to overview]Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.
NCT00362232 (16) [back to overview]Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.
NCT00362232 (16) [back to overview]Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.
NCT00362232 (16) [back to overview]The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit
NCT00362232 (16) [back to overview]Treatment-emergent Major Bleedings Per Safety Population.
NCT00402597 (6) [back to overview]The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke
NCT00402597 (6) [back to overview]Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)
NCT00402597 (6) [back to overview]The Number of Deaths (All Cause)
NCT00402597 (6) [back to overview]The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke
NCT00402597 (6) [back to overview]The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit
NCT00402597 (6) [back to overview]The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)
NCT00403767 (10) [back to overview]The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death
NCT00403767 (10) [back to overview]The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction
NCT00403767 (10) [back to overview]The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism
NCT00403767 (10) [back to overview]The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke
NCT00403767 (10) [back to overview]The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death
NCT00403767 (10) [back to overview]The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death
NCT00403767 (10) [back to overview]The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)
NCT00403767 (10) [back to overview]All-cause Mortality
NCT00403767 (10) [back to overview]The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety
NCT00403767 (10) [back to overview]The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)
NCT00439725 (20) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With All Death
NCT00439725 (20) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With Symptomatic Recurrent PE During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With Recurrent DVT During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With Other Vascular Events
NCT00439725 (20) [back to overview]Percentage of Participants With Major Bleeding
NCT00439725 (20) [back to overview]Percentage of Participants With Clinically Relevant Bleeding
NCT00439725 (20) [back to overview]Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period
NCT00439725 (20) [back to overview]Percentage of Participants With Death (PE) Until the Intended End of Study Treatment
NCT00439725 (20) [back to overview]Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period
NCT00439777 (16) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
NCT00439777 (16) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With All Deaths
NCT00439777 (16) [back to overview]Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
NCT00439777 (16) [back to overview]Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
NCT00439777 (16) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
NCT00439777 (16) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period
NCT00439777 (16) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
NCT00439777 (16) [back to overview]Percentage of Participants With Recurrent DVT During Observational Period
NCT00439777 (16) [back to overview]Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
NCT00439777 (16) [back to overview]Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period
NCT00440193 (15) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period
NCT00440193 (15) [back to overview]Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
NCT00440193 (15) [back to overview]Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
NCT00440193 (15) [back to overview]Percentage of Participants With Recurrent DVT During Observational Period
NCT00440193 (15) [back to overview]Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period
NCT00440193 (15) [back to overview]Percentage of Participants With All Deaths
NCT00440193 (15) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period
NCT00440193 (15) [back to overview]Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
NCT00440193 (15) [back to overview]Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period
NCT00494871 (12) [back to overview]Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death
NCT00494871 (12) [back to overview]Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death
NCT00494871 (12) [back to overview]Event Rate of Vascular Death
NCT00494871 (12) [back to overview]Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism
NCT00494871 (12) [back to overview]Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding
NCT00494871 (12) [back to overview]Event Rate of Stroke With Serious Residual Disability
NCT00494871 (12) [back to overview]Event Rate of Stroke
NCT00494871 (12) [back to overview]Event Rate of Non-CNS Systemic Embolism
NCT00494871 (12) [back to overview]Event Rate of Myocardial Infarction
NCT00494871 (12) [back to overview]Event Rate of All-cause Death
NCT00494871 (12) [back to overview]Event Rate of Adjudicated Major Bleeding
NCT00494871 (12) [back to overview]Event Rate Adjudicated Non-major Clinically Relevant Bleeding
NCT00571649 (14) [back to overview]Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
NCT00571649 (14) [back to overview]Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
NCT00571649 (14) [back to overview]Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
NCT00571649 (14) [back to overview]Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population
NCT00571649 (14) [back to overview]Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days
NCT00571649 (14) [back to overview]Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days
NCT00571649 (14) [back to overview]Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)
NCT00571649 (14) [back to overview]Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)
NCT00786422 (10) [back to overview]Percentage of Participants With All Deaths
NCT00786422 (10) [back to overview]Percentage of Participants With Other Vascular Events
NCT00786422 (10) [back to overview]Percentage of Participants With Treatment Emergent Deaths - 7 Days Window
NCT00786422 (10) [back to overview]Pharmacodynamics - Prothrombin Time (PT), Baseline Value
NCT00786422 (10) [back to overview]Pharmacodynamics - Prothrombin Time (PT), Slope
NCT00786422 (10) [back to overview]Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban
NCT00786422 (10) [back to overview]Pharmacokinetics - Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban
NCT00786422 (10) [back to overview]Pharmacokinetics - Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban
NCT00786422 (10) [back to overview]Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)
NCT00786422 (10) [back to overview]Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
NCT00809965 (5) [back to overview]The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
NCT00809965 (5) [back to overview]The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
NCT00809965 (5) [back to overview]The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
NCT00809965 (5) [back to overview]The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
NCT00809965 (5) [back to overview]The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
NCT01094886 (4) [back to overview]Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa
NCT01094886 (4) [back to overview]Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time
NCT01094886 (4) [back to overview]Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)
NCT01094886 (4) [back to overview]Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time
NCT01436526 (8) [back to overview]Half-life Associated With the Terminal Slope (t½)
NCT01436526 (8) [back to overview]Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)
NCT01436526 (8) [back to overview]Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation
NCT01436526 (8) [back to overview]Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation
NCT01436526 (8) [back to overview]Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation
NCT01436526 (8) [back to overview]Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)
NCT01436526 (8) [back to overview]Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)
NCT01436526 (8) [back to overview]Mean Residence Time (MRT)
NCT01499953 (6) [back to overview]Major Bleeding (Main Safety Outcome)
NCT01499953 (6) [back to overview]Rate of Major VTE
NCT01499953 (6) [back to overview]Clinically Relevant Non-major, Minor and Total (Any) Bleeding
NCT01499953 (6) [back to overview]Rates of Surgery for SVT
NCT01499953 (6) [back to overview]Rate of Objectively Confirmed VTE Complications
NCT01499953 (6) [back to overview]Composite Primary Efficacy Outcome
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor IIa Activity
NCT01507051 (42) [back to overview]Maximum Drug Concentration in Plasma (Cmax) of Rivaroxaban After First Dose
NCT01507051 (42) [back to overview]Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of S-warfarin After the Last Dose of Warfarin
NCT01507051 (42) [back to overview]Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of R-warfarin After the Last Dose of Warfarin
NCT01507051 (42) [back to overview]Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of S-warfarin After the Last Dose of Warfarin
NCT01507051 (42) [back to overview]Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of R-warfarin After the Last Dose of Warfarin
NCT01507051 (42) [back to overview]Drug Concentration in Plasma at Expected Time of Minimum (Trough) Concentration (Ctrough) of Rivaroxaban After Second to Fourth Dose
NCT01507051 (42) [back to overview]Drug Concentration in Plasma at Expected Time of Maximum (Peak) Concentration (Cpeak) of Rivaroxaban After Second to Fourth Dose
NCT01507051 (42) [back to overview]Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Rivaroxaban After First Dose
NCT01507051 (42) [back to overview]Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Rivaroxaban After First Dose
NCT01507051 (42) [back to overview]Half Life Associated With Terminal Slope (t1/2) of S-warfarin After the Last Dose of Warfarin
NCT01507051 (42) [back to overview]Half Life Associated With Terminal Slope (t1/2) of Rivaroxaban After Last Dose
NCT01507051 (42) [back to overview]Half Life Associated With Terminal Slope (t1/2) of R-warfarin After the Last Dose of Warfarin
NCT01507051 (42) [back to overview]Emax,BA (Baseline Adjusted Maximum Effect) on Prothrombin Time (Coagulation Test)
NCT01507051 (42) [back to overview]Emax on PT (Measured as INR=International Normalized Ratio)
NCT01507051 (42) [back to overview]Emax on Factor Xa Activity
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test)
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on PiCT (Prothrombinase-induced Clotting Time)
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on HepTest (Coagulation Test)
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on Factor VIIa Activity
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on Factor IIa Activity
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak Time
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Lag Time
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) AUC
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on aPTT (Activated Partial Thromboplastin Time)
NCT01507051 (42) [back to overview]Emax (Maximum Effect) on Anti-Factor Xa Activity
NCT01507051 (42) [back to overview]AUCBA(0-tn) (Baseline Adjusted Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of PiCT (Prothrombinase-induced Clotting Time)
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of HepTest (Coagulation Test)
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor VIIa Activity
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak Time
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Lag Time
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) AUC
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of aPTT (Activated Partial Thromboplastin Time)
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Anti-Factor Xa Activity
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) for PT (Measured as INR=International Normalized Ratio)
NCT01507051 (42) [back to overview]AUC(0-tn) (Area Under the Inverse Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor Xa Activity
NCT01507051 (42) [back to overview]Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Divided by Dose Per kg Body Weight [AUC(0-24)Norm] of Rivaroxaban After First Dose
NCT01507051 (42) [back to overview]Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of Rivaroxaban After First Dose
NCT01629381 (4) [back to overview]Major Bleedings
NCT01629381 (4) [back to overview]Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality
NCT01629381 (4) [back to overview]Combined Incidence of All DVT Plus Symptomatic PE
NCT01629381 (4) [back to overview]Overall Incidence of Bleeding
NCT01674647 (11) [back to overview]Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death
NCT01674647 (11) [back to overview]Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality
NCT01674647 (11) [back to overview]Number of Participants With Strokes
NCT01674647 (11) [back to overview]Number of Participants With Transient Ischemic Attacks
NCT01674647 (11) [back to overview]Number of Participants With Major Bleedings as Per Central Adjudication
NCT01674647 (11) [back to overview]Number of Participants With Composite of Major and Non-major Bleeding Events
NCT01674647 (11) [back to overview]Number of Participants With Cardiovascular Deaths
NCT01674647 (11) [back to overview]Number of Participants With All-cause Mortality
NCT01674647 (11) [back to overview]Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms
NCT01674647 (11) [back to overview]Number of Participants With Myocardial Infarctions
NCT01674647 (11) [back to overview]Number of Participants With Non-central Nervous System Systemic Embolisms
NCT01684423 (7) [back to overview]Anti-factor Xa Values at Specified Time Points
NCT01684423 (7) [back to overview]Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events
NCT01684423 (7) [back to overview]Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
NCT01684423 (7) [back to overview]Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden
NCT01684423 (7) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
NCT01684423 (7) [back to overview]Change From Baseline in Prothrombin Time at Specified Time Points
NCT01684423 (7) [back to overview]Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
NCT01706146 (2) [back to overview]Number of Days on Anticoagulation
NCT01706146 (2) [back to overview]Bleeding Incidence
NCT01729871 (6) [back to overview]Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism
NCT01729871 (6) [back to overview]Number of Participants With Vascular Death
NCT01729871 (6) [back to overview]Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death
NCT01729871 (6) [back to overview]Number of Participants With Myocardial Infarction (MI)
NCT01729871 (6) [back to overview]Number of Participants With Ischemic Stroke
NCT01729871 (6) [back to overview]Number of Participants With Incidence of Post-Procedure Major Bleeding Events
NCT01776424 (8) [back to overview]The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part
NCT01776424 (8) [back to overview]The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
NCT01776424 (8) [back to overview]The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part
NCT01776424 (8) [back to overview]The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death
NCT01776424 (8) [back to overview]The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death
NCT01776424 (8) [back to overview]The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death
NCT01776424 (8) [back to overview]All-cause Mortality in LTOLE Part
NCT01776424 (8) [back to overview]All-cause Mortality
NCT01830543 (9) [back to overview]Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
NCT01830543 (9) [back to overview]Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
NCT01830543 (9) [back to overview]Percentage of Participants With Stroke
NCT01830543 (9) [back to overview]Percentage of Participants With Stent Thrombosis
NCT01830543 (9) [back to overview]Percentage of Participants With Myocardial Infarction
NCT01830543 (9) [back to overview]Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)
NCT01830543 (9) [back to overview]Percentage of Participants With Cardiovascular Death
NCT01830543 (9) [back to overview]Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)
NCT01830543 (9) [back to overview]Percentage of Participants With Clinically Significant Bleeding
NCT01877915 (9) [back to overview]Event Rate of Re-Hospitalization for Worsening of Heart Failure
NCT01877915 (9) [back to overview]Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability
NCT01877915 (9) [back to overview]Event Rate of Bleeding Events That Requiring Hospitalization
NCT01877915 (9) [back to overview]Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure
NCT01877915 (9) [back to overview]Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke
NCT01877915 (9) [back to overview]Event Rate of Cardio Vascular Death
NCT01877915 (9) [back to overview]Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)
NCT01877915 (9) [back to overview]Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event
NCT01877915 (9) [back to overview]Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)
NCT01999179 (5) [back to overview]Number of Participants With Recurrent Thrombosis
NCT01999179 (5) [back to overview]PTS Assessment Completion
NCT01999179 (5) [back to overview]Biomarker Sample Collection
NCT01999179 (5) [back to overview]Number of Participants With Major Bleeding
NCT01999179 (5) [back to overview]Number of Participants With Post-thrombotic Syndrome
NCT02042534 (5) [back to overview]The Number of Patients With Recurrent Ischemic Lesion
NCT02042534 (5) [back to overview]Length of Hospitalization
NCT02042534 (5) [back to overview]Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging
NCT02042534 (5) [back to overview]Number of Participants With Modified Rankin Score of 0 or 1 at Week 4
NCT02042534 (5) [back to overview]The Number of Patients With Intracranial Bleeding
NCT02064439 (4) [back to overview]Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
NCT02064439 (4) [back to overview]Number of Participants With First Treatment-emergent Major Bleeding
NCT02064439 (4) [back to overview]Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
NCT02064439 (4) [back to overview]Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in D-Dimer
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in AH
NCT02072668 (12) [back to overview]Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)
NCT02072668 (12) [back to overview]Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in RF
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in TAT
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in TH1
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in TM
NCT02072668 (12) [back to overview]Change in Ratio From Baseline to Week 4 in AH/AO
NCT02072668 (12) [back to overview]Change From Baseline to Week 4 in PF
NCT02111564 (7) [back to overview]Event Rate Based on Time From Randomization to First Occurrence of VTE-Related Death Adjudicated by CEC
NCT02111564 (7) [back to overview]Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC
NCT02111564 (7) [back to overview]Time From Randomization to First Occurrence of Composite of All Symptomatic Venous Thromboembolism (VTE) and VTE Related Death Adjudicated by Clinical Event Committee (CEC)
NCT02111564 (7) [back to overview]Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC
NCT02111564 (7) [back to overview]Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC
NCT02111564 (7) [back to overview]Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC
NCT02111564 (7) [back to overview]Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC
NCT02164578 (10) [back to overview]Clinically Relevant Non-major (CRNM) Bleeding
NCT02164578 (10) [back to overview]Clinically Relevant Non-major (CRNM) Bleeding
NCT02164578 (10) [back to overview]Change in Skin Blood Flow
NCT02164578 (10) [back to overview]Change in Skin Blood Flow
NCT02164578 (10) [back to overview]Change in Pulse Wave Velocity
NCT02164578 (10) [back to overview]Change in Pulse Wave Velocity
NCT02164578 (10) [back to overview]Change in Post-ischemic Forearm Blood Flow
NCT02164578 (10) [back to overview]Change in Post-ischemic Forearm Blood Flow
NCT02164578 (10) [back to overview]Major Bleeding
NCT02164578 (10) [back to overview]Major Bleeding
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
NCT02234843 (36) [back to overview]Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period
NCT02234843 (36) [back to overview]Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
NCT02234843 (36) [back to overview]Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period
NCT02234843 (36) [back to overview]Ctrough,ss in Plasma
NCT02234843 (36) [back to overview]Cmax,ss in Plasma
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
NCT02234843 (36) [back to overview]AUC(0-24)ss in Plasma
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years
NCT02234843 (36) [back to overview]Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
NCT02234843 (36) [back to overview]Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period
NCT02234843 (36) [back to overview]Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
NCT02234843 (36) [back to overview]Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
NCT02234843 (36) [back to overview]Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
NCT02234843 (36) [back to overview]Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years
NCT02234843 (36) [back to overview]Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years
NCT02234843 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years
NCT02234843 (36) [back to overview]Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication)
NCT02260622 (10) [back to overview]Number of Participants With 2 Class Improvement on the Rutherford Scale
NCT02260622 (10) [back to overview]Overall Survival
NCT02260622 (10) [back to overview]Reintervention, Above Ankle Amputation and Restenosis (RAS)
NCT02260622 (10) [back to overview]The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR)
NCT02260622 (10) [back to overview]TVR
NCT02260622 (10) [back to overview]Minor Bleeding
NCT02260622 (10) [back to overview]Major Bleeding
NCT02260622 (10) [back to overview]MACE
NCT02260622 (10) [back to overview]Peri-procedure Death
NCT02260622 (10) [back to overview]Event-free Survival
NCT02293395 (1) [back to overview]Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
NCT02309411 (7) [back to overview]Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
NCT02309411 (7) [back to overview]Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events
NCT02309411 (7) [back to overview]Number of Subjects With Symptomatic Recurrent Venous Thromboembolism
NCT02309411 (7) [back to overview]Anti-factor Xa Values at Specified Time Points
NCT02309411 (7) [back to overview]Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points
NCT02309411 (7) [back to overview]Change From Baseline in Prothrombin Time at Specified Time Points
NCT02309411 (7) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points
NCT02313909 (8) [back to overview]Incidence Rate of Clinically Relevant Non-Major Bleeding Events
NCT02313909 (8) [back to overview]Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction
NCT02313909 (8) [back to overview]Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)
NCT02313909 (8) [back to overview]Incidence Rate of All-Cause Mortality
NCT02313909 (8) [back to overview]Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
NCT02313909 (8) [back to overview]Incidence Rate of the Composite Efficacy Outcome (Adjudicated)
NCT02313909 (8) [back to overview]Incidence Rate of Life-Threatening Bleeding Events
NCT02313909 (8) [back to overview]Incidence Rate of Intracranial Hemorrhage
NCT02331095 (11) [back to overview]Change in the Levels of C-Reactive Protein at 3 Months
NCT02331095 (11) [back to overview]Change in Low-Density Lipoproteins (LDL) at 3 Months
NCT02331095 (11) [back to overview]The Rate of Residual (Chronic) Vein Obstruction by Doppler Ultrasound
NCT02331095 (11) [back to overview]The Reduction of Peak Thrombin Concentration
NCT02331095 (11) [back to overview]The Reduction of Endogenous Thrombin Potential
NCT02331095 (11) [back to overview]The Reduction of Clinical Post-thrombotic Syndrome (PTS), as Objectively Evaluated With Villalta Scoring System
NCT02331095 (11) [back to overview]The Rate of Major, Non-major, and All Hemorrhages Defined by the International Society on Thrombosis and Haemostasis (ISTH) Criteria
NCT02331095 (11) [back to overview]The Rate of Arterial Thrombotic Events
NCT02331095 (11) [back to overview]The Composite Rate of Recurrent Venous Thromboembolism (VTE) and VTE Related Mortality
NCT02331095 (11) [back to overview]Change in Triglyceride Levels at 3 Months
NCT02331095 (11) [back to overview]Change in the Levels of D-Dimer at 3 Months
NCT02376010 (2) [back to overview]Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA)
NCT02376010 (2) [back to overview]Coronary Artery Calcium (Serial Calcium Scans)
NCT02504216 (11) [back to overview]Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology
NCT02504216 (11) [back to overview]Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology
NCT02504216 (11) [back to overview]Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)
NCT02504216 (11) [back to overview]Number of Mortality (All-cause)
NCT02504216 (11) [back to overview]Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding
NCT02504216 (11) [back to overview]Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events
NCT02504216 (11) [back to overview]Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding
NCT02504216 (11) [back to overview]Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology
NCT02504216 (11) [back to overview]Number of Participants With Venous Thromboembolic (VTE) Events
NCT02504216 (11) [back to overview]Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature
NCT02504216 (11) [back to overview]Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology
NCT02555878 (13) [back to overview]Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4
NCT02555878 (13) [back to overview]Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3
NCT02555878 (13) [back to overview]Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2
NCT02555878 (13) [back to overview]Percentage of Participants With All-Cause Mortality
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Minor Bleeding
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
NCT02555878 (13) [back to overview]Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding
NCT02555878 (13) [back to overview]Percentage of Participants With Time to the First Occurrence of Any Bleeding
NCT02556203 (8) [back to overview]Number of Participants With Death or First Thromboembolic Event (DTE)
NCT02556203 (8) [back to overview]Number of Participants With Cardiovascular Death or Thromboembolic Event
NCT02556203 (8) [back to overview]Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds
NCT02556203 (8) [back to overview]Number of Participants With Death or First Thromboembolic Event (DTE)
NCT02556203 (8) [back to overview]Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds
NCT02556203 (8) [back to overview]Number of Participants With Net-clinical Benefit
NCT02556203 (8) [back to overview]Number of Participants With Primary Bleeding Event (PBE)
NCT02556203 (8) [back to overview]Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds
NCT02564718 (14) [back to overview]Change From Baseline in Prothrombin Time at Day 3
NCT02564718 (14) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8
NCT02564718 (14) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
NCT02564718 (14) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3
NCT02564718 (14) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3
NCT02564718 (14) [back to overview]Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events
NCT02564718 (14) [back to overview]Change From Baseline in Prothrombin Time at Day 1
NCT02564718 (14) [back to overview]Anti-factor Xa Activity (Anti-Xa) Values at Day 8
NCT02564718 (14) [back to overview]Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1
NCT02564718 (14) [back to overview]Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3
NCT02564718 (14) [back to overview]Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1
NCT02564718 (14) [back to overview]Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging
NCT02564718 (14) [back to overview]Anti-factor Xa Activity (Anti-Xa) Values at Day 1
NCT02564718 (14) [back to overview]Anti-factor Xa Activity (Anti-Xa) Values at Day 3
NCT02584660 (6) [back to overview]Mean Duration of Hospitalization
NCT02584660 (6) [back to overview]Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire
NCT02584660 (6) [back to overview]Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)
NCT02584660 (6) [back to overview]Percentage of Participants With Reoccurrence of Symptomatic Venous Thromboembolism Event (VTE) (Composite of Recurrent PE, New or Recurrent DVT) or VTE-related Death
NCT02584660 (6) [back to overview]Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding
NCT02584660 (6) [back to overview]Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason
NCT02666742 (12) [back to overview]Number of Participants With Heart Block
NCT02666742 (12) [back to overview]Number of Participants With Transient Ischemic Attack
NCT02666742 (12) [back to overview]Number of Participants With Stroke
NCT02666742 (12) [back to overview]Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours
NCT02666742 (12) [back to overview]Number of Participants With Acute Procedure Related Complications
NCT02666742 (12) [back to overview]Number of Participants With Groin Hematoma
NCT02666742 (12) [back to overview]Number of Participants With Fatal Pulmonary Embolism
NCT02666742 (12) [back to overview]Number of Participants With Cardiac Tamponade
NCT02666742 (12) [back to overview]Number of Participants With In-hospital Mortality
NCT02666742 (12) [back to overview]Number of Participants With Retroperitoneal Bleed
NCT02666742 (12) [back to overview]Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)
NCT02666742 (12) [back to overview]Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
NCT02701062 (8) [back to overview]Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
NCT02701062 (8) [back to overview]Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
NCT02701062 (8) [back to overview]Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
NCT02701062 (8) [back to overview]Number of Perioperative Complications Associated With AtriClip Placement
NCT02701062 (8) [back to overview]Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
NCT02701062 (8) [back to overview]Number of Subjects With Intraoperative Successful Exclusion of LAA.
NCT02744092 (11) [back to overview]Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
NCT02744092 (11) [back to overview]Cumulative Rates of Major Bleeding
NCT02744092 (11) [back to overview]Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02829957 (9) [back to overview]Number of Participants Who Discontinued Planned Drug Administration
NCT02829957 (9) [back to overview]Number of Participants With Clinically Relevant Non-major Bleeding
NCT02829957 (9) [back to overview]Number of Participants With Venous Thromboembolism (VTE)
NCT02829957 (9) [back to overview]Number of Patients That Held Drug for Menorrhagia
NCT02829957 (9) [back to overview]PBAC Scores
NCT02829957 (9) [back to overview]Physical Component Summary of Standard From 36
NCT02829957 (9) [back to overview]Number of Participants Who Crossed Over to Another Anticoagulant
NCT02829957 (9) [back to overview]Number of Participants With Major Hemorrhage
NCT02829957 (9) [back to overview]Hemoglobin Concentration
NCT02833948 (10) [back to overview]The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan
NCT02833948 (10) [back to overview]The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan
NCT02833948 (10) [back to overview]Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis.
NCT02833948 (10) [back to overview]Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography.
NCT02833948 (10) [back to overview]Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis.
NCT02833948 (10) [back to overview]Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis.
NCT02833948 (10) [back to overview]Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography.
NCT02833948 (10) [back to overview]Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis.
NCT02833948 (10) [back to overview]Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan
NCT02833948 (10) [back to overview]The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan
NCT02846532 (36) [back to overview]Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]aPTT at Day 4 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]Absolute PT at Day 4 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Percentage of Participants With Bleeding Events
NCT02846532 (36) [back to overview]Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)
NCT02846532 (36) [back to overview]aPTT at Month 3 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]aPTT at Month 3 (2.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute PT at Day 1 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute PT at Day 4 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute PT at Day 4 (6-8 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute PT at Day 4 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]Absolute PT at Month 3 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute PT at Month 3 (2.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute PT at Month 3 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Anti-FXa at Day 1 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Anti-FXa at Day 4 (6-8 Hours Postdose)
NCT02846532 (36) [back to overview]Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]Anti-FXa at Month 3 (2.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]Anti-FXa at Month 3 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]aPTT at Month 3 (Up to 3 Hours Predose)
NCT02846532 (36) [back to overview]aPTT at Day 1 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]aPTT at Day 4 (0.5-1.5 Hours Postdose)
NCT02846532 (36) [back to overview]aPTT at Day 4 (1.5-4 Hours Postdose)
NCT02846532 (36) [back to overview]aPTT at Day 4 (6-8 Hours Postdose)
NCT03026556 (13) [back to overview]Hemorrhagic Stroke
NCT03026556 (13) [back to overview]Lower GI Bleeding
NCT03026556 (13) [back to overview]Major Urogenital Bleeding
NCT03026556 (13) [back to overview]Major Other Bleeding
NCT03026556 (13) [back to overview]Major Intracranial Bleeding
NCT03026556 (13) [back to overview]Stroke Overall (Hemorrhagic, Ischemic, Uncertain)
NCT03026556 (13) [back to overview]Major Extracranial Bleeding
NCT03026556 (13) [back to overview]Ischemic Stroke
NCT03026556 (13) [back to overview]Upper GI Bleeding
NCT03026556 (13) [back to overview]All-cause Mortality
NCT03026556 (13) [back to overview]TIA
NCT03026556 (13) [back to overview]Overall Major Bleeding
NCT03026556 (13) [back to overview]Major GI Bleeding
NCT03196349 (7) [back to overview]Number of Subjects Experiencing Clinically Relevant Non-major Bleeding
NCT03196349 (7) [back to overview]Number of Subjects Experiencing Major Bleeding
NCT03196349 (7) [back to overview]Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)
NCT03196349 (7) [back to overview]Number of Subjects With Clinically Relevant Bleeding Events
NCT03196349 (7) [back to overview]Number of Subjects With Premature Termination of Study Medication
NCT03196349 (7) [back to overview]Number of Subjects With Recurrent Venous Thromboembolism (VTE)
NCT03196349 (7) [back to overview]Number of Subjects Experiencing All-cause Mortality
NCT03254147 (2) [back to overview]The Number of Patients With Cardiac Tamponade and Pericardiocentesis.
NCT03254147 (2) [back to overview]The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.
NCT03310021 (6) [back to overview]Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.
NCT03310021 (6) [back to overview]Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.
NCT03310021 (6) [back to overview]Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.
NCT03310021 (6) [back to overview]Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.
NCT03328832 (3) [back to overview]Total Blood Loss After Operation
NCT03328832 (3) [back to overview]Blood Transfusion Rate
NCT03328832 (3) [back to overview]Incidence of Thrombosis Events
NCT03413618 (11) [back to overview]Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score
NCT03413618 (11) [back to overview]Number of Participants With Full Recanalization of the Popliteal Vein
NCT03413618 (11) [back to overview]Minor Bleeding
NCT03413618 (11) [back to overview]Major Bleeding
NCT03413618 (11) [back to overview]Extension of Residual Venous Obstruction by Marder Score
NCT03413618 (11) [back to overview]Clinically Relevant Non-major Bleeding
NCT03413618 (11) [back to overview]Adverse Events
NCT03413618 (11) [back to overview]The Value of Venous Clinical Severity Score
NCT03413618 (11) [back to overview]The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items
NCT03413618 (11) [back to overview]Number of Participants With Symptomatic Pulmonary Embolism
NCT03413618 (11) [back to overview]Number of Participants With Recurrent Symptomatic or Asymptomatic DVT
NCT03441633 (10) [back to overview]Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
NCT03441633 (10) [back to overview]Risk of Thromboembolic Events: CHADS2 Score
NCT03441633 (10) [back to overview]Risk of Thromboembolic Events: CHA2DS2Vasc Score
NCT03441633 (10) [back to overview]Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year
NCT03441633 (10) [back to overview]Number of Participants by Comorbidity
NCT03441633 (10) [back to overview]Number of Participants by Comedications
NCT03441633 (10) [back to overview]Risk of Bleeding Events: HAS-BLED Score
NCT03441633 (10) [back to overview]Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)
NCT03441633 (10) [back to overview]Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)
NCT03441633 (10) [back to overview]International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA
NCT03572972 (16) [back to overview]Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03572972 (16) [back to overview]Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis
NCT03572972 (16) [back to overview]Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis
NCT03578146 (9) [back to overview]Andexanet Total Volume of Distribution (Vss)
NCT03578146 (9) [back to overview]Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration
NCT03578146 (9) [back to overview]Andexanet Total Systemic Clearance (CL)
NCT03578146 (9) [back to overview]Andexanet Time of Maximum Observed Plasma Concentration (Tmax)
NCT03578146 (9) [back to overview]Andexanet Maximum Observed Plasma Concentration (Cmax)
NCT03578146 (9) [back to overview]Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )
NCT03578146 (9) [back to overview]Andexanet Apparent Terminal Elimination Half-life (t1/2)
NCT03578146 (9) [back to overview]Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration
NCT03578146 (9) [back to overview]Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration
NCT03718429 (3) [back to overview]Platelet Aggregation Measured by VerifyNow PRU
NCT03718429 (3) [back to overview]Platelet-Mediated Global Thrombogenicity
NCT03718429 (3) [back to overview]Thrombin Generation
NCT03864406 (8) [back to overview]Time to Maximum Plasma Concentration (Tmax) for Rivaroxaban
NCT03864406 (8) [back to overview]Terminal Elimination Half-life (t½) for Rivaroxaban
NCT03864406 (8) [back to overview]Minimum Total Plasma Concentration (Cmin) for Rivaroxaban
NCT03864406 (8) [back to overview]Maximum Total Plasma Concentration (Cmax) for Rivaroxaban
NCT03864406 (8) [back to overview]Area Under the Concentration Versus Time Curve (AUC0-24hr) for Rivaroxaban
NCT03864406 (8) [back to overview]Area Under the Concentration Versus Time Curve (AUC0-∞) for Rivaroxaban
NCT03864406 (8) [back to overview]Apparent Volume of Distribution (V/F) for Rivaroxaban
NCT03864406 (8) [back to overview]Apparent Oral Clearance (CL/F) for Rivaroxaban
NCT04006288 (1) [back to overview]Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)
NCT04504032 (15) [back to overview]Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28
NCT04504032 (15) [back to overview]Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35
NCT04504032 (15) [back to overview]Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35
NCT04504032 (15) [back to overview]Number of Participants With Serious Adverse Events Through Day 35
NCT04504032 (15) [back to overview]Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21
NCT04504032 (15) [back to overview]Number of Participants With Hospitalization Through Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Median Number of Days of Hospitalization Through Day 35
NCT04504032 (15) [back to overview]Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28
NCT04504032 (15) [back to overview]Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28
NCT04504032 (15) [back to overview]Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28
NCT04508023 (5) [back to overview]Number of Participants Who Were Hospitalized or Dead on Day 35
NCT04508023 (5) [back to overview]Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint
NCT04508023 (5) [back to overview]Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes
NCT04508023 (5) [back to overview]Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria
NCT04508023 (5) [back to overview]Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria
NCT05022563 (60) [back to overview]Number of Participants Who Completely Discontinued Index Anticoagulant Treatment
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants Who Switched to Another Anticoagulant Therapy
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery
NCT05022563 (60) [back to overview]Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE
NCT05022563 (60) [back to overview]Time to Treatment Switch
NCT05022563 (60) [back to overview]Time to Treatment Interruption
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Cancer-related Event
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation
NCT05022563 (60) [back to overview]Overall Index Anticoagulant Treatment Duration
NCT05022563 (60) [back to overview]Number of Participants With Interruption in Index Anticoagulant Treatment
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism
NCT05022563 (60) [back to overview]Time to Treatment Discontinuation
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Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 16 days after surgery

InterventionPercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)6.94
Enoxaparin 30 mg Twice a Day (Bid)10.11

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Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 16 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)6.32
Enoxaparin 30 mg Twice a Day (Bid)8.97

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Incidence of DVT (Proximal, Distal) Per Protocol Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 16 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)6.37
Enoxaparin 30 mg Twice a Day (Bid)8.66

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Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 16 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)1.14
Enoxaparin 30 mg Twice a Day (Bid)1.88

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Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 16 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)1.04
Enoxaparin 30 mg Twice a Day (Bid)1.48

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Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population

Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 16 days after surgery

InterventionPercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)6.71
Enoxaparin 30 mg Twice a Day (Bid)9.34

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Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 47 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)0.31
Enoxaparin 30 mg Twice a Day (Bid)0.21

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Incidence of Symptomatic VTE During Follow-up Per Protocol Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography (NCT00362232)
Timeframe: Up to 47 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)0.35
Enoxaparin 30 mg Twice a Day (Bid)0.11

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The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions (NCT00362232)
Timeframe: Up to 47 days after surgery

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)2.04
Enoxaparin 30 mg Twice a Day (Bid)2.33

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Treatment-emergent Major Bleedings Per Safety Population.

Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report) (NCT00362232)
Timeframe: from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).

Interventionpercentage of participants (Number)
Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)0.66
Enoxaparin 30 mg Twice a Day (Bid)0.27

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The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke

The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact. (NCT00402597)
Timeframe: Day 1 to Day 210

InterventionPatients (Number)
Placebo63
Riva 5 mg Total Daily Dose (TDD)18
Riva 10 mg TDD40
Riva 15 mg TDD21
Riva 20 mg TDD21

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Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)

The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention. (NCT00402597)
Timeframe: Day 1 to Day 210

InterventionPatients (Number)
Placebo36
Riva 5 mg Total Daily Dose (TDD)17
Riva 10 mg TDD109
Riva 15 mg TDD43
Riva 20 mg TDD89

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The Number of Deaths (All Cause)

The number of patients who died due to any cause from the time of randomization to the last date of patient contact. (NCT00402597)
Timeframe: Day 1 to Day 210

InterventionPatients (Number)
Placebo18
Riva 5 mg Total Daily Dose (TDD)11
Riva 10 mg TDD9
Riva 15 mg TDD4
Riva 20 mg TDD9

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The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke

The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact. (NCT00402597)
Timeframe: Day 1 to Day 210

InterventionPatients (Number)
Placebo66
Riva 5 mg Total Daily Dose (TDD)18
Riva 10 mg TDD40
Riva 15 mg TDD21
Riva 20 mg TDD22

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The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit

The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban. (NCT00402597)
Timeframe: Day 1 to Day 210

InterventionPatients (Number)
Placebo88
Riva 5 mg Total Daily Dose (TDD)24
Riva 10 mg TDD71
Riva 15 mg TDD35
Riva 20 mg TDD48

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The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)

The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact. (NCT00402597)
Timeframe: Day 1 to Day 210

InterventionPatients (Number)
Placebo83
Riva 5 mg Total Daily Dose (TDD)23
Riva 10 mg TDD55
Riva 15 mg TDD27
Riva 20 mg TDD36

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The Composite Event of Stroke/Non-CNS Systemic Embolism/Vascular Death

The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban346
Warfarin410

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The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Myocardial Infarction

The number of patients with the first occurrence of a myocardial infarction while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban101
Warfarin126

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The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Non-CNS Systemic Embolism

The number of patients with the first occurrence of a non-CNS systemic embolism while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban5
Warfarin22

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The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Stroke

The number of patients with the first occurrence of a stroke while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban184
Warfarin221

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The Composite Event of Stroke/Non-CNS Systemic Embolism/Myocardial Infarction/Vascular Death

The number of patients with the first occurrence of a stroke, non-CNS systemic embolism, myocardial infarction, or vascular death while on treatment. The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban433
Warfarin519

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The Individual Components of the Composite Primary and Major Secondary Efficacy Outcome Measures: Vascular Death

The number of patients with the occurrence of vascular death while on treatment. The statistical analysis is based on time from randomization to the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban170
Warfarin193

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The Composite of Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Superiority)

The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban189
Warfarin243

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All-cause Mortality

The number of patients who died due to any cause while on treatment. The statistical analysis is based on time from randomization to the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban208
Warfarin250

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The Composite Event of Major/Non-major Clinically Relevant Bleeding Events: Primary Safety

The number of patients with the first occurrence of a major or non-major clinically relevant bleeding event while on treatment. The statistical analysis is based on time from the first dose of study drug to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban1475
Warfarin1449

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The Composite Event of Stroke/Non-CNS Systemic Embolism: Primary Efficacy (Non-Inferiority)

The number of patients with the first occurrence of a stroke or non-CNS systemic embolism while on treatment (defined as the time interval from the first dose to the last dose of study drug plus 2 days). The statistical analysis is based on time from randomization to the first occurrence of the event while on treatment. (NCT00403767)
Timeframe: Up to 4 years

InterventionPatients (Number)
Rivaroxaban188
Warfarin241

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.4
Placebo1.1

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Percentage of Participants With All Death

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. Treatment-emergent events and all events post randomization were reported. Treatment-emergent: after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days) (NCT00439725)
Timeframe: 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
Treatment-emergent (time window: 2 days)All post-randomization
Placebo0.20.3
Rivaroxaban (Xarelto, BAY59-7939)0.20.2

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE, All Cause Mortality, Strokes and Myocardial Infarctions Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.5
Placebo7.4

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), or lung scintigraphy (for PE), and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.3
Placebo7.2

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Placebo1.1

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Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. For definition of DVT/PE, kindly refer to the link in the Protocol section. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.3
Placebo7.1

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Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Placebo0.9

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Percentage of Participants With Symptomatic Recurrent PE During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.3
Placebo0.2

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Percentage of Participants With Recurrent VTE (PE or DVT) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Placebo7.1

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Percentage of Participants With Recurrent VTE (PE or DVT) During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Placebo0.9

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Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.8
Placebo5.2

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Percentage of Participants With Recurrent DVT During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound or venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.9
Placebo0.7

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Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.0
Placebo7.1

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Percentage of Participants With Symptomatic Recurrent PE Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either spiral computed tomography (CT) scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.3
Placebo2.2

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Percentage of Participants With Other Vascular Events

All pre-defined vascular events (acute coronary syndromes, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism and vascular death) were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on results/films/images of confirmatory testing, and/or case summaries. On treatment events and all events post randomization were reported. On treatment: after intake of first tablet of study medication as randomized but not more than 1 day after stop of study medication (referred to as time window: 1 day) (NCT00439725)
Timeframe: 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
On treatment (time window: 1 day)All post-randomization
Placebo0.70.7
Rivaroxaban (Xarelto, BAY59-7939)0.50.8

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Percentage of Participants With Major Bleeding

All events were adjudicated and confirmed by a central independent adjudication committee (CIAC) blinded to treatment. Major bleeding event was overt bleeding associated with a 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Treatment-emergent [after intake of first tablet of study medication as randomized but not more than 2 days after stop of study medication (referred to as time window: 2 days)] events and all events post randomization were reported. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
Treatment-emergent (time window: 2 days)All post-randomization
Placebo0.00.2
Rivaroxaban (Xarelto, BAY59-7939)0.70.7

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Percentage of Participants With Clinically Relevant Bleeding

All events adjudicated/confirmed by CIAC blinded to treatment. Clinically relevant bleeding included major bleeding (definition: see outcome 7) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of daily life activities. Treatment-emergent events (after intake of 1st study medication tablet as randomized up to 2 days after stop of study medication ['time window: 2 days']) and all events post randomization were reported (NCT00439725)
Timeframe: 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
Treatment-emergent (time window: 2 days)All post-randomization
Placebo1.21.9
Rivaroxaban (Xarelto, BAY59-7939)6.06.0

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Percentage of Participants With Net Clinical Benefit as Composite of Recurrent DVT or Non-fatal or Fatal PE and Major Bleeding Events During Observational Period

Events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral CT scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units, occurring in a critical site or contributing to death. (NCT00439725)
Timeframe: 30 days observational period after last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Placebo0.9

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Percentage of Participants With Death (PE) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.0
Placebo0.2

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Percentage of Participants With Death (PE Cannot be Excluded) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439725)
Timeframe: 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.2
Placebo0.0

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Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. (NCT00439777)
Timeframe: 3-, 6-, or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.1
Enoxaparin/VKA1.8

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Percentage of Participants With Symptomatic Recurrent VTE (i.e. the Composite of Recurrent DVT or Fatal or Non-fatal PE) During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.9
Enoxaparin/VKA0.7

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.1
Enoxaparin/VKA1.5

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6-, or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.0
Enoxaparin/VKA3.4

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Percentage of Participants With All Deaths

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
All post-randomizationTreatment-emergent (time window: 2 days)Treatment-emergent (time window: 7 days)
Enoxaparin/VKA2.10.81.1
Rivaroxaban (Xarelto, BAY59-7939)2.61.21.5

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Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

,
InterventionPercentage of participants (Number)
Death (PE)Death (PE cannot be excluded)Symptomatic PE and DVTSymptomatic recurrent PE onlySymptomatic recurrent DVT onlyDeath (bleeding)Death (cardiovascular)Death (other)Major bleeding
Enoxaparin/VKA00.0500.50.10.090.050.70.5
Rivaroxaban (Xarelto, BAY59-7939)0.0900.090.50.20.090.30.80.3

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Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)10.3
Enoxaparin/VKA11.4

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Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Enoxaparin/VKA1.2

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Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6-, or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)3.4
Enoxaparin/VKA4.0

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Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.5
Enoxaparin/VKA1.4

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Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding (associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death), cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography (PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.5
Enoxaparin/VKA4.8

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Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
Death (PE)Death (PE cannot be excluded)Symptomatic PE and DVTSymptomatic recurrent PE onlySymptomatic recurrent DVT onlyDeath (bleeding)Death (cardiovascular)Death (other)Major bleeding
Enoxaparin/VKA0.040.20.10.80.70.20.11.52.4
Rivaroxaban (Xarelto, BAY59-7939)0.10.30.01.00.70.20.41.31.4

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Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)

All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.5
Enoxaparin/VKA1.5

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Percentage of Participants With Recurrent DVT During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.3
Enoxaparin/VKA0.1

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Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.7
Enoxaparin/VKA0.8

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Percentage of Participants With Recurrent PE Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00439777)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.4
Enoxaparin/VKA1.2

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Percentage of Participants With an Event for Net Clinical Benefit 2 Until the Intended End of Study Treatment

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to transfusion of ≥2 units, occurring in a critical site or contributing to death, cardiovascular death, myocardial infarction, stroke, and non CNS (central nervous system) systemic embolism. Net clinical benefit was considered greater in those participants with fewer composite events. All events confirmed by independent committee blinded to treatment, based on compression ultrasound, venography, spiral CT scan, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy, results/films/images of confirmatory testing and/or case summaries (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)3.6
Enoxaparin/VKA4.7

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Percentage of Participants With an Event for Net Clinical Benefit 1 During Observational Period

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE or major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.1
Enoxaparin/VKA1.1

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Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment

Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.9
Enoxaparin/VKA4.2

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Percentage of Participants With an Event for Net Clinical Benefit 2 During Observational Period

Net clinical benefit 2: composite of recurrent DVT or non-fatal or fatal PE, major bleeding, cardiovascular death, myocardial infarctions, stroke, or non CNS systemic embolism. Major bleeding was associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound (DVT), venography (DVT), spiral CT scanning (PE), pulmonary angiography ( PE), ventilation/perfusion lung scan (PE), lung scintigraphy (PE), autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.2
Enoxaparin/VKA1.3

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Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.9
Enoxaparin/VKA1.6

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Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)8.1
Enoxaparin/VKA8.1

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Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)

All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.7
Enoxaparin/VKA0.8

[back to top]

Percentage of Participants With Recurrent DVT During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.6
Enoxaparin/VKA0.3

[back to top]

Percentage of Participants With the Individual Components of Efficacy Outcomes Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
Death (PE)Death (PE cannot be excluded)Symptomatic PE and DVTSymptomatic recurrent PE onlySymptomatic recurrent DVT onlyDeath (bleeding)Death (cardiovascular)Death (other)Major bleeding
Enoxaparin/VKA00.301.01.60.30.22.01.3
Rivaroxaban (Xarelto, BAY59-7939)0.060.20.061.20.80.060.11.80.9

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Percentage of Participants With the Individual Components of Efficacy Outcomes During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of ≥2 units, occurring in a critical site or contributing to death. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

,
InterventionPercentage of participants (Number)
Death (PE)Death (PE cannot be excluded)Symptomatic PE and DVTSymptomatic recurrent PE onlySymptomatic recurrent DVT onlyDeath (bleeding)Death (cardiovascular)Death (other)Major bleeding
Enoxaparin/VKA00.0700.10.30.10.30.80.6
Rivaroxaban (Xarelto, BAY59-7939)00.0700.30.60.070.071.30.2

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Percentage of Participants With All Deaths

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

,
InterventionPercentage of participants (Number)
All post-randomizationTreatment-emergent (time window: 2 days)Treatment-emergent (time window: 7 days)
Enoxaparin/VKA3.01.11.5
Rivaroxaban (Xarelto, BAY59-7939)2.41.01.2

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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.0
Enoxaparin/VKA5.1

[back to top]

Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.2
Enoxaparin/VKA1.8

[back to top]

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries. (NCT00440193)
Timeframe: 3-, 6- or 12-month study treatment period

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.1
Enoxaparin/VKA3.0

[back to top]

Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) During Observational Period

All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), results/films/images of confirmatory testing, and/or case summaries. (NCT00440193)
Timeframe: Up to 30 days after the last intake of study medication

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.8
Enoxaparin/VKA0.5

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Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, and Vascular Death

"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Any death that was not clearly non-vascular." (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.83
Warfarin2.85

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Event Rate of the Composite Endpoint of Adjudicated Stroke, Non-CNS Systemic Embolism, Myocardial Infarction, and Vascular Death

"Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded. Myocardial infarction: assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for ≥2 leads, or autopsy confirmation. Any death that was not clearly non-vascular." (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.18
Warfarin2.97

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Event Rate of Vascular Death

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia) (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.69
Warfarin0.24

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Event Rate of the Composite Endpoint of Adjudicated Stroke and Non-central Nervous System (CNS) Systemic Embolism

"This is the principal efficacy endpoint. Stroke included hemorrhagic, ischemic infarction and unknown. Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded." (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.26
Warfarin2.61

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Event Rate of the Composite Endpoint of Adjudicated Major Bleeding or Adjudicated Non-major Clinically Relevant Bleeding

Major bleeding: clinically overt bleeding (COB) associated with a fall in hemoglobin ≥2 g/dL, leading to transfusion ≥2 units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Non-major clinically relevant bleeding: COB that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life. (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)18.04
Warfarin16.42

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Event Rate of Stroke With Serious Residual Disability

All events were adjudicated and confirmed by a central independent committee blinded to treatment. A stroke was considered disabling if the participant's modified Rankin score was between 3 and 5, inclusive. (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.57
Warfarin1.19

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Event Rate of Stroke

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded.), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available.). (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)1.15
Warfarin2.49

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Event Rate of Non-CNS Systemic Embolism

"All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-CNS systemic embolism was abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (such as trauma, atherosclerosis, and instrumentation). Arterial emboli in the following areas were non-CNS systemic embolism: peripheral arterial in the upper and lower extremities, renal, mesenteric, splenic, hepatic, ocular/retinal and others. Pulmonary embolism or myocardial infarction was excluded from this category." (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.11
Warfarin0.12

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Event Rate of Myocardial Infarction

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Myocardial infarction was assessed based on either cardiac bio-markers (troponin I, troponin T, or creatine kinase-muscle and brain subunit isozyme), new abnormal Q waves appeared on ECG for 2 or more leads, or autopsy confirmation. (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.34
Warfarin0.12

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Event Rate of All-cause Death

All events were adjudicated and confirmed by a central independent committee blinded to treatment. All-cause death included vascular death and non-vascular death. (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.80
Warfarin0.59

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Event Rate of Adjudicated Major Bleeding

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 g/dL or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)3.00
Warfarin3.59

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Event Rate Adjudicated Non-major Clinically Relevant Bleeding

All events were adjudicated and confirmed by a central independent committee blinded to treatment. Non-major clinically relevant bleeding was clinically overt bleeding that does not meet the definition of major bleeding, but requires medical intervention or unscheduled contact with the physician, (temporary) discontinuation of the study treatment, discomfort to the subject such as pain, or impairment of activities of daily life. (NCT00494871)
Timeframe: Up to 2 days after the last dose

InterventionEvents per 100 patient-years (Number)
Rivaroxaban (Xarelto, BAY59-7939)15.42
Warfarin12.99

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Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related). (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.8
Enoxaparin4.5

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Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days

All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths. (NCT00571649)
Timeframe: Up to Day 90 + 7 days

,
InterventionPercentage of participants (Number)
Any eventDeath (cardiovascular)Death (other)VTE related death
Enoxaparin6.21.43.71.1
Rivaroxaban (Xarelto, BAY59-7939)6.71.44.31.0

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Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90

Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category. (NCT00571649)
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days

,
InterventionPercentage of participants (Number)
Any event-Day 10Ischemic stroke-Day 10Acute MI-Day 10Death (cardiovascular)-Day 10Any event-Day 35Ischemic stroke-Day 35Acute MI-Day 35Death (cardiovascular)-Day 35Any event-Day 90Ischemic stroke-Day 90Acute MI-Day 90Death (cardiovascular)-Day 90
Enoxaparin1.00.30.40.41.60.50.50.82.81.10.71.4
Rivaroxaban (Xarelto, BAY59-7939)1.00.30.50.41.80.50.60.92.80.80.91.4

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Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days

A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related). (NCT00571649)
Timeframe: Up to Day 35 + 6 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)8.6
Enoxaparin9.2

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Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days)

Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin or transfusion of >=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding. (NCT00571649)
Timeframe: Up to Day 10 + 5 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2.8
Enoxaparin1.2

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Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days)

Major bleeding events were defined as events leading to >=2 g/dL fall in hemoglobin; or transfusion of >= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding (NCT00571649)
Timeframe: Up to Day 35 + 6 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4.1
Enoxaparin1.7

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Percentage of Participants With All Deaths

All deaths were adjudicated by a central independent adjudication committee. Participants who died for any reason were counted for this measure. (NCT00786422)
Timeframe: Up to 3 months and on-treatment (up to 2 days after stop of study drug) plus an observational period planned for one month

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)12.0

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Percentage of Participants With Other Vascular Events

All events were adjudicated and confirmed by a central independent adjudication committee. Other vascular events comprised ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), unstable angina (UA), ischemic stroke, transient ischemic attack (TIA), non-central nervous system systemic embolism and vascular death. (NCT00786422)
Timeframe: Up to 3 months treatment and during subsequent 1 day

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.0

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Percentage of Participants With Treatment Emergent Deaths - 7 Days Window

Treatment emergent deaths were adjudicated by a central independent adjudication committee. Participants who died from treatment emergent adverse events were counted for this measure. (NCT00786422)
Timeframe: Up to 3 months treatment and during subsequent 7 days

InterventionPercentage of participants (Number)
Rivaroxaban (Xarelto, BAY59-7939)8.0

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Pharmacodynamics - Prothrombin Time (PT), Baseline Value

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Mean and standard deviation (SD) values are presented for PT baseline. (NCT00786422)
Timeframe: The baseline value of prothrombin time is measured or calculated at a rivaroxaban concentration of 0 µg/L and is based on the observations that were made during the 3 months treatment period

InterventionSeconds (Mean)
Rivaroxaban (Xarelto, BAY59-7939)15.8

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Pharmacodynamics - Prothrombin Time (PT), Slope

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out of PT is in seconds. The PT slope describes the linear increase of PT for one unit increase in concentration, thus the unit of PT slope is s*(µg/L)^-1. The final population PK/PD model included a fixed slope that was fitted to the data of the 19 patients that were eligible for evaluation. The estimated mean value (fixed/ the same for all patients in this study) is presented for PT slope. (NCT00786422)
Timeframe: Up to 3 months treatment

Interventions*(µg/L)^-1 (Number)
Rivaroxaban (Xarelto, BAY59-7939)0.0389

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Pharmacokinetics - AUC(0-24)ss (Area Under the Measurement Versus Time Curve From Time 0 to 24 Hours After First Dosing on a Day at Steady State) of Rivaroxaban

AUC(0-24)ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inducer. (NCT00786422)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

Intervention(µg*h)/L (Median)
Rivaroxaban Initial Treatment2836
Rivaroxaban Extended Treatment2319

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Pharmacokinetics - Cmax,ss (Maximum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban

Cmax,ss was predicted from rivaroxaban plasma concentrations for each individual participant and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer. (NCT00786422)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

Interventionµg/L (Median)
Rivaroxaban Initial Treatment200
Rivaroxaban Extended Treatment167

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Pharmacokinetics - Cmin,ss (Minimum Observed Drug Concentration in Measured Matrix at Steady State During a Dosage Interval) of Rivaroxaban

Cmin,ss was predicted for each individual participant from rivaroxaban plasma concentrations and was only considered for the time period during which participants concomitantly received rivaroxaban and a strong CYP3A4 inducer. (NCT00786422)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

Interventionµg/L (Median)
Rivaroxaban Initial Treatment42
Rivaroxaban Extended Treatment35

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Percentage of Participants With Clinically Relevant Bleeding (i.e. Major Bleeding and Clinically Relevant Non-major Bleeding)

All events were adjudicated and confirmed by a central independent adjudication committee. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. (NCT00786422)
Timeframe: Up to 3 months treatment and during subsequent 2 days

InterventionPercentage of participants (Number)
Any confirmed bleedingClinically relevant non-major bleedingTrivial bleeding
Rivaroxaban (Xarelto, BAY59-7939)12.08.08.0

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Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Non-fatal or Fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment

All events were adjudicated and confirmed by a central independent adjudication committee. The composite efficacy outcome symptomatic recurrent VTE was analyzed descriptively, with the components: Death due to PE, death for which PE cannot be excluded, symptomatic PE and DVT, symptomatic recurrent PE only, and symptomatic recurrent DVT only up to the end of intended treatment period (3 months; 98 study days) and on-treatment (up to 2 days after stop of study drug). (NCT00786422)
Timeframe: Up to 3 months treatment and during subsequent 30-day observational period for an individual participant

InterventionPercentage of participants (Number)
symptomatic recurrent VTE (composite)DeathSymptomatic recurrent deep vein thrombosis only
Rivaroxaban (Xarelto, BAY59-7939)8.04.04.0

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The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke

The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment. (NCT00809965)
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

InterventionPercentage of patients (Number)
Placebo7.5
Rivaroxaban 2.5 mg Bid6.3
Rivaroxaban 5 mg Bid6.3

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The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery

The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment. (NCT00809965)
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

InterventionPercentage of patients (Number)
Placebo7.6
Rivaroxaban 2.5 mg Bid7.1
Rivaroxaban 5 mg Bid7.2

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The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization

The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment. (NCT00809965)
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

InterventionPercentage of patients (Number)
Placebo8.7
Rivaroxaban 2.5 mg Bid7.3
Rivaroxaban 5 mg Bid7.6

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The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization

The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment. (NCT00809965)
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

InterventionPercentage of patients (Number)
Placebo9.4
Rivaroxaban 2.5 mg Bid8.5
Rivaroxaban 5 mg Bid8.2

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The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke

The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment. (NCT00809965)
Timeframe: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)

InterventionPercentage of patients (Number)
Placebo7.4
Rivaroxaban 2.5 mg Bid6.1
Rivaroxaban 5 mg Bid6.1

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Summary of Change From Day 1 to Day 3 in Area Under the Curve (AUC) of aFXa

Descriptive statistics for Area Under the Curve (AUC) on Study Day 1 and Day 3 for Anti-Factor Xa, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose (NCT01094886)
Timeframe: Day 1, Day 3

InterventionIU/ml*hour (Mean)
Day 1Day 3
Rivaroxaban21.3520.74

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Summary of Change From Day 1 to Day 3 in AUC of Prothrombin Time

Descriptive statistics for AUC on Study Day 1 and Day 3 for prothrombin time, based on the 7 consecutive blood draws at 0, 2, 4, 6, 8, 12 and 24 hours post dose (NCT01094886)
Timeframe: Day 1, Day 3

Interventionsec*hour (Mean)
Day 1Day 3
Rivaroxaban420.46391.37

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Summary of Change From Day 3 to Day 1 in Maximum Anti-Factor Xa (aFXa)

Descriptive statistics for per-patient maximum Anti-Factor Xa laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3 (NCT01094886)
Timeframe: Day 1, Day 3

InterventionIU/ml (Mean)
Day 1Day 3
Rivaroxaban1.661.83

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Summary of Change From Day 3 to Day 1 in Maximum Prothrombin Time

Descriptive statistics for per-patient maximum prothrombin time laboratory value selected from the 7 consecutive blood draws (0, 2, 4, 6, 8, 12 and 24 hrs post dose) on Day 1 and Day 3 (NCT01094886)
Timeframe: Day 1, Day 3

Interventionsec (Mean)
Day 1Day 3
Rivaroxaban21.5720.51

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Half-life Associated With the Terminal Slope (t½)

Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionhr (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg8.932
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg8.721

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Maximum Observed Drug Concentration in Plasma After Single Dose Administration Divided by Dose Per kg Body Weight (Cmax, Norm)

Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionkg/L (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg1.412
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg1.265

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Maximum Observed Drug Concentration in Plasma After Single Dose Administration (Cmax) Incl. Bioequivalence (BE) Evaluation

Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionµg/L (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg179.8
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg161.1

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Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity After Single Dose (AUC) Incl. Bioequivalence (BE) Evaluation

The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample (AUC is defined as area under the concentration vs. time curve from zero to infinity after single (first) dose). (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionµg*hr/L (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg1374
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg1268

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Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration [AUC (0-tn)] Incl. Bioequivalence (BE) Evaluation

The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC (0-tn)] is defined as AUC from time 0 to the last data point above the Lower Limit of Quantification. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionµg*hr/L (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg1354
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg1252

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Area Under the Plasma Concentration Versus Time Curve Divided by Dose Per kg Body Weight (AUCnorm)

The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; AUCnorm is defined as AUC divided by dose per kg body weight. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionkg*hr/L (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg10.79
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg9.957

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Time to Reach Maximum Drug Concentration in Plasma After Single Dose (Tmax)

Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionhr (Median)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg2.50
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg2.50

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Mean Residence Time (MRT)

The mean residence time is the average time that the molecules introduced into the body stay in the body. (NCT01436526)
Timeframe: 0 min, 15 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 15 hours, 24 hours, 36 hours, 48 hours and 72 hours post administration

Interventionhr (Geometric Mean)
Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg8.874
Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg9.284

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Major Bleeding (Main Safety Outcome)

"associated with a fall of hemoglobin of 2 g/l or more, or;~leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or;~occurring into a critical site such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or;~fatal bleeding." (NCT01499953)
Timeframe: 45 +/- 5 days

InterventionParticipants (Count of Participants)
Rivaroxaban0
Fondaparinux0

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Rate of Major VTE

"composite of:~symptomatic pulmonary embolism~symptomatic proximal DVT~VTE-related death" (NCT01499953)
Timeframe: 90 +/-10 days

,
InterventionParticipants (Count of Participants)
Deep vein thrombosisPulmonary embolismVTE-related death
Fondaparinux200
Rivaroxaban600

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Clinically Relevant Non-major, Minor and Total (Any) Bleeding

"Clinically relevant, non-major bleeding is defined as any overt bleeding and~associated with a medical intervention, or~unscheduled contact with the physician (presence or telephone contact)~temporary or complete cessation of study drug~associated with any relevant discomfort to the patient (pain, impairment of activities of daily life)" (NCT01499953)
Timeframe: 45 +/- 5 days

,
InterventionParticipants (Count of Participants)
CRNM bleedingMinor bleedingAny bleeding
Fondaparinux11516
Rivaroxaban61520

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Rates of Surgery for SVT

(NCT01499953)
Timeframe: 90 +/-10 days

InterventionParticipants (Count of Participants)
Rivaroxaban0
Fondaparinux2

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Rate of Objectively Confirmed VTE Complications

The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension towards the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis (confirmed by ultrasonography) up to day 45. (NCT01499953)
Timeframe: 45 +/- 5 days

InterventionParticipants (Count of Participants)
Rivaroxaban7
Fondaparinux4

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Composite Primary Efficacy Outcome

For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT. (NCT01499953)
Timeframe: 90 +/- 10 days

InterventionParticipants (Count of Participants)
Rivaroxaban15
Fondaparinux15

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor IIa Activity

Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor IIa activity was the area under the measurement (Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at baseline divided by Factor IIa activity [measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)62.26
Warfarin Followed by Placebo58.60
Rivaroxaban (Xarelto, BAY59-7939)3.908

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Maximum Drug Concentration in Plasma (Cmax) of Rivaroxaban After First Dose

Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

Interventionmicrog/L (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)219.8
Rivaroxaban (Xarelto, BAY59-7939)221.0

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Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of S-warfarin After the Last Dose of Warfarin

Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose. (NCT01507051)
Timeframe: 0 h (predose) and 24 h after the last administration of warfarin

,
Intervention1/Liter (Geometric Mean)
before last administrationafter last administration
Warfarin Followed by Placebo0.046710.04786
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)0.047240.05580

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Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration, Normalized by Dose (Ctrough,ss/D) of R-warfarin After the Last Dose of Warfarin

Ctrough,ss/D refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration, normalized by dose. (NCT01507051)
Timeframe: 0 h (predose) and 24 h after the last administration of warfarin

,
Intervention1/Liter (Geometric Mean)
before last administrationafter last administration
Warfarin Followed by Placebo0.078430.07915
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)0.071540.08633

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Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of S-warfarin After the Last Dose of Warfarin

Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration. (NCT01507051)
Timeframe: 0 h (predose) and 24 h after the last administration of warfarin

,
InterventionMicrog/L (Geometric Mean)
before last administrationafter last administration
Warfarin Followed by Placebo429.9424.9
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)498.2478.4

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Drug Concentration in Plasma at Steady State at Expected Time of Minimum (Trough) Concentration (Ctrough,ss) of R-warfarin After the Last Dose of Warfarin

Ctrough,ss refers to the drug concentration at steady state at the time when it is expected to reach its minimum (trough) concentration. (NCT01507051)
Timeframe: 0 h (predose) and 24 h after the last administration of warfarin

,
InterventionMicrog/L (Geometric Mean)
before last administrationafter last administration
Warfarin Followed by Placebo721.8702.8
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)754.4740.2

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Drug Concentration in Plasma at Expected Time of Minimum (Trough) Concentration (Ctrough) of Rivaroxaban After Second to Fourth Dose

Ctrough refers to the time after dosing when the drug concentration is expected to reach its minimum (trough) concentration. (NCT01507051)
Timeframe: Always 24 h after the second, third, and fourth dose

,
InterventionMicrog/L (Geometric Mean)
second dosethird dosefourth dose
Rivaroxaban (Xarelto, BAY59-7939)17.0715.8515.61
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)13.0614.3412.43

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Drug Concentration in Plasma at Expected Time of Maximum (Peak) Concentration (Cpeak) of Rivaroxaban After Second to Fourth Dose

Cpeak refers to the time after dosing when the drug concentration is expected to reach its maximum (peak) concentration. (NCT01507051)
Timeframe: Always 3 h after second, third, and fourth dose

,
InterventionMicrog/L (Geometric Mean)
second dosethird dosefourth dose
Rivaroxaban (Xarelto, BAY59-7939)206.7201.0214.5
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)211.2206.1201.4

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Time to Reach Maximum Drug Concentration in Plasma (Tmax) of Rivaroxaban After First Dose

Tmax refers to the time after dosing when a drug attains its highest measurable concentration (Cmax). It is obtained by collecting a series of blood samples at various times after dosing, and measuring them for drug content. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

Interventionhours (Median)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)3.008
Rivaroxaban (Xarelto, BAY59-7939)3.000

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Maximum Drug Concentration in Plasma Divided by Dose Per kg Body Weight (Cmax,Norm) of Rivaroxaban After First Dose

Cmax refers to the highest measured drug concentration which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; Cmax,norm is defined as Cmax divided by dose (mg) per kg body weight. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

InterventionKg/L (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)0.8812
Rivaroxaban (Xarelto, BAY59-7939)0.8857

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Half Life Associated With Terminal Slope (t1/2) of S-warfarin After the Last Dose of Warfarin

Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. (NCT01507051)
Timeframe: Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin

Interventionhours (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)28.24
Warfarin Followed by Placebo27.08

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Half Life Associated With Terminal Slope (t1/2) of Rivaroxaban After Last Dose

Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. (NCT01507051)
Timeframe: 3, 24, 48, and 72 h after the last administration of rivaroxaban

Interventionhours (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)6.885
Rivaroxaban (Xarelto, BAY59-7939)6.931

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Half Life Associated With Terminal Slope (t1/2) of R-warfarin After the Last Dose of Warfarin

Half-life refers to the elimination of the drug, i.e. the time it takes for the blood plasma concentration to reach half the concentration in the terminal phase of elimination. (NCT01507051)
Timeframe: Blood samples taken at 24, 30, 48, 54, 72, 96, and 120 h after the last administration of warfarin

Interventionhours (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)40.08
Warfarin Followed by Placebo40.24

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Emax,BA (Baseline Adjusted Maximum Effect) on Prothrombin Time (Coagulation Test)

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax,BA on PT was measured as maximum PT (measured in seconds) minus PT (measured in seconds) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionseconds (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)44.98
Warfarin Followed by Placebo11.59
Rivaroxaban (Xarelto, BAY59-7939)7.31

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Emax on PT (Measured as INR=International Normalized Ratio)

Prothrombin time - INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. Emax on PT (INR) was measured as the ratio of maximum INR divided by baseline INR. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)6.655
Warfarin Followed by Placebo2.250
Rivaroxaban (Xarelto, BAY59-7939)1.793

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Emax on Factor Xa Activity

Test to measure the activity of endogenous Factor Xa. Emax on Factor Xa activity was calculated as 100*(Factor Xa activity at baseline [measured as activity per mL] - minimum of Factor Xa activity [measured as activity per mL]) / Factor Xa activity at baseline [measured as activity per mL]. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

InterventionPercentage of inhibition (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)75.95
Warfarin Followed by Placebo43.41
Rivaroxaban (Xarelto, BAY59-7939)49.73

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Emax (Maximum Effect) on Prothrombin Time (PT) (Coagulation Test)

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. Emax on PT was measured as the ratio of maximum PT (measured in seconds) divided by PT (measured in seconds) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)4.393
Warfarin Followed by Placebo1.884
Rivaroxaban (Xarelto, BAY59-7939)1.573

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Emax (Maximum Effect) on PiCT (Prothrombinase-induced Clotting Time)

This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on PiCT was measured as the ratio of maximum PiCT (measured in seconds) divided by PiCT (measured in seconds) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)3.158
Warfarin Followed by Placebo1.139
Rivaroxaban (Xarelto, BAY59-7939)2.723

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Emax (Maximum Effect) on HepTest (Coagulation Test)

This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. Emax on HepTest was measured as the ratio of maximum HepTest (measured in seconds) divided by HepTest (measured in seconds) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)2.148
Warfarin Followed by Placebo1.163
Rivaroxaban (Xarelto, BAY59-7939)2.009

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Emax (Maximum Effect) on Factor VIIa Activity

Factor VII is a coagulation factor that is required for the coagulation process. Emax on Factor VIIa activity was measured as the ratio of Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma) at baseline divided by minimum Factor VIIa activity (measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma). (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)12.80
Warfarin Followed by Placebo6.769
Rivaroxaban (Xarelto, BAY59-7939)1.346

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Emax (Maximum Effect) on Factor IIa Activity

Factor II (Thrombin) is a coagulation factor that is required for the coagulation process. Emax on Factor IIa activity was measured as the ratio of Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma) at baseline divided by minimum Factor IIa activity (measured as percent of actual Factor IIa activity compared to Factor IIa activity in reference plasma). (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)3.166
Warfarin Followed by Placebo2.958
Rivaroxaban (Xarelto, BAY59-7939)1.126

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Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak Time

ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak time was measured as the ratio of maximum ETP peak time (measured in minutes as time to reach the maximum coagulation activity) divided by ETP peak time (measured in minutes as time to reach the maximum coagulation activity) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)4.164
Warfarin Followed by Placebo1.375
Rivaroxaban (Xarelto, BAY59-7939)3.790

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Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Peak

ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP peak was measured as the ratio of ETP peak (measured in nm as maximum coagulation activity) at baseline divided by minimum ETP peak (measured in nm as maximum coagulation activity). (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)18.73
Warfarin Followed by Placebo2.523
Rivaroxaban (Xarelto, BAY59-7939)6.758

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Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) Lag Time

ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. Emax on ETP lag time was measured as the ratio of maximum ETP lag time (in minutes as measure for the start of coagulation) divided by ETP lag time (in minutes as measure for the start of coagulation) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)3.954
Warfarin Followed by Placebo1.748
Rivaroxaban (Xarelto, BAY59-7939)2.569

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Emax (Maximum Effect) on ETP (Endogenous Thrombin Potential) AUC

ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. Emax on ETP AUC was measured as the ratio of ETP AUC (measured in nm*min as integral of fluorescence measurements) at baseline divided by minimum ETP AUC (measured in nm*min as integral of fluorescence measurements). (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)4.257
Warfarin Followed by Placebo2.610
Rivaroxaban (Xarelto, BAY59-7939)1.813

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Emax (Maximum Effect) on aPTT (Activated Partial Thromboplastin Time)

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. Emax on aPTT was measured as the ratio of maximum aPTT (measured in seconds) divided by aPTT (measured in seconds) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)1.843
Warfarin Followed by Placebo1.304
Rivaroxaban (Xarelto, BAY59-7939)1.409

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Emax (Maximum Effect) on Anti-Factor Xa Activity

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. Emax on anti-Factor Xa activity was measured as the ratio of maximum anti-Factor Xa activity (measured in U/L) divided by anti-Factor Xa activity (measured in U/L) at baseline. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)15.83
Warfarin Followed by Placebo2.281
Rivaroxaban (Xarelto, BAY59-7939)18.57

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AUCBA(0-tn) (Baseline Adjusted Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUCBA(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points minus PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventions*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)413.4
Warfarin Followed by Placebo179.9
Rivaroxaban (Xarelto, BAY59-7939)33.06

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Prothrombin Time (Coagulation Test)

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT was the area under the measurement (PT [measured in seconds] at different time-points divided by PT [measured in seconds] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)55.36
Warfarin Followed by Placebo37.89
Rivaroxaban (Xarelto, BAY59-7939)20.41

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of PiCT (Prothrombinase-induced Clotting Time)

This coagulation test can be adapted to measure different anticoagulants, including inhibitors of Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PiCT was the area under the measurement (PiCT [measured in seconds] at different time-points divided by PiCT [measured in seconds] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)37.36
Warfarin Followed by Placebo4.221
Rivaroxaban (Xarelto, BAY59-7939)39.20

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of HepTest (Coagulation Test)

This coagulation test was developed to monitor heparin and especially low-molecular weight heparins (LMWH). It is sensitive to measure Factor X. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of HepTest was the area under the measurement (HepTest [measured in seconds] at different time-points divided by HepTest [measured in seconds] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)27.37
Warfarin Followed by Placebo15.08
Rivaroxaban (Xarelto, BAY59-7939)28.25

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor VIIa Activity

Factor VII is a coagulation factor that is required for the coagulation process. AUC(0-tn) of Factor VIIa activity was the area under the measurement (Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at baseline divided by Factor VIIa activity [measured as percent of actual Factor VIIa activity compared to Factor VIIa activity in reference plasma] at different time-points) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)134.2
Warfarin Followed by Placebo94.83
Rivaroxaban (Xarelto, BAY59-7939)9.283

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak Time

ETP peak time assesses the overall function of the clotting cascade. The peak time assesses the time required to reach the maximal thrombin generation. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak time was the area under the measurement (ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at different time-points divided by ETP peak time [measured in minutes as time to reach the maximum coagulation activity] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)49.14
Warfarin Followed by Placebo19.83
Rivaroxaban (Xarelto, BAY59-7939)55.58

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Peak

ETP peak assesses the overall function of the clotting cascade. The peak assesses the overall maximal ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP peak was the area under the measurement (ETP peak [measured in nm as maximum coagulation activity] at baseline divided by ETP peak measured [in nm as maximum coagulation activity] at different time-points) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)166.8
Warfarin Followed by Placebo46.75
Rivaroxaban (Xarelto, BAY59-7939)74.67

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) Lag Time

ETP lag time assesses the overall function of the clotting cascade. The lag time assesses the time required until thrombin is generated. Increasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP lag time was the area under the measurement (ETP lag time [in minutes as measure for the start of coagulation] at different time-points divided by ETP lag time [in minutes as measure for the start of coagulation] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)63.75
Warfarin Followed by Placebo34.93
Rivaroxaban (Xarelto, BAY59-7939)42.79

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of ETP (Endogenous Thrombin Potential) AUC

ETP AUC assesses the overall function of the clotting cascade. The AUC assesses the overall ability to generate thrombin. Decreasing values compared to baseline indicate an anticoagulant effect. AUC(0-tn) of ETP AUC was the area under the measurement (ETP AUC [measured in nm*min as integral of fluorescence measurements] at baseline divided by ETP AUC [measured in nm*min as integral of fluorescence measurements] at different time-points) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)69.69
Warfarin Followed by Placebo51.28
Rivaroxaban (Xarelto, BAY59-7939)18.06

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of aPTT (Activated Partial Thromboplastin Time)

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V, VIII, IX, X, XI and XII. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of aPTT was the area under the measurement (aPTT [measured in seconds] at different time-points divided by aPTT [measured in seconds] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)32.48
Warfarin Followed by Placebo22.55
Rivaroxaban (Xarelto, BAY59-7939)21.82

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) of Anti-Factor Xa Activity

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. Higher Values than the baseline indicate a more pronounced inhibition. AUC(0-tn) of anti-Factor Xa activity was the area under the measurement (anti-Factor Xa activity [measured in U/L] at different time-points divided by anti-Factor Xa activity [measured in U/L] at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)124.9
Warfarin Followed by Placebo19.63
Rivaroxaban (Xarelto, BAY59-7939)151.6

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AUC(0-tn) (Area Under the Measurement Versus Time Curve From Time 0 to the Last Data Point) for PT (Measured as INR=International Normalized Ratio)

Prothrombin time - INR measured in seconds that is calculated as INR which is a correction for PT assay differences and an optimization to measure vitamin K antagonists. Higher values than the baseline indicate anticoagulant effects. AUC(0-tn) of PT (INR) was the area under the measurement (PT measured as INR at different time-points divided by PT measured as INR at baseline) versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

Interventionratio*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)72.30
Warfarin Followed by Placebo43.60
Rivaroxaban (Xarelto, BAY59-7939)23.21

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AUC(0-tn) (Area Under the Inverse Measurement Versus Time Curve From Time 0 to the Last Data Point) of Factor Xa Activity

Test to measure the activity of endogenous Factor Xa. AUC(0-tn) of Factor Xa activity was the area under the inverse measurement [100*(Factor Xa activity at baseline (measured as activity per mL) - Factor Xa activity (measured as activity per mL) at different time-points) / Factor Xa activity at baseline (measured as activity per mL)] versus time curve from time 0 to the last data point. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban or placebo

InterventionPercentage of inhibition*h (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)1238
Warfarin Followed by Placebo834.8
Rivaroxaban (Xarelto, BAY59-7939)514.1

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Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours Divided by Dose Per kg Body Weight [AUC(0-24)Norm] of Rivaroxaban After First Dose

The AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample; [AUC(0-24)norm] is defined as AUC divided by dose per kg body weight from zero to 24 hours after first (single) dose. (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

InterventionKg*h/L (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)6.569
Rivaroxaban (Xarelto, BAY59-7939)6.901

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Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of Rivaroxaban After First Dose

The AUC is a measure of systemic drug exposure which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample ([AUC(0-24)] is defined as area under the concentration vs. time curve from zero to 24 hours after first (single) dose). (NCT01507051)
Timeframe: 0 (predose), 1, 2, 3, 4, 6, 8, 12, and 24 h after first administration of rivaroxaban

Interventionmicrog*h/L (Geometric Mean)
Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)1639
Rivaroxaban (Xarelto, BAY59-7939)1722

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Major Bleedings

Major bleeding include: clinically overt haemorrhage associated with haemoglobin drop of at least 2 g/L or requiring the transfusion of two or more units of packed red-blood cells; retroperitoneal or intracranial events; bleeding requiring re-intervention; and hemarthrosis with a joint drainage of more than 450 millilitres of blood. (NCT01629381)
Timeframe: 3 months

Interventionparticipants (Number)
Placebo0
Rivaroxaban 10 mg for 7 Days0

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Incidence of Symptomatic Venous Thromboembolism Plus Asymptomatic Proximal Vein Thrombosis and All-cause Mortality

During the scheduled visit in case of suspected DVT a bilateral whole-leg colour-coded Doppler ultrasonography (CCDU) is scheduled for all patients at 7 (+1) days of follow-up; additionally, CCDU will be performed if the patients develop symptoms or signs suggestive of venous thromboembolism earlier; in case of suspected PE a multi-slice chest TC-angio is arranged; in case of death for all cause autoptic findings are requested or, if necessary, clinical ground is considered. A follow-up visit is planned 3-month period after the randomization. (NCT01629381)
Timeframe: 3-month period

Interventionparticipants (Number)
Rivaroxaban1
Placebo7

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Combined Incidence of All DVT Plus Symptomatic PE

As described for the assessment of the primary efficacy outcomes (NCT01629381)
Timeframe: 3 months

Interventionparticipants (Number)
Placebo8
Rivaroxaban 10 mg for 7 Days2

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Overall Incidence of Bleeding

As described for the primary safety outcome (NCT01629381)
Timeframe: 3 months

Interventionparticipants (Number)
Placebo6
Rivaroxaban 10 mg for 7 Days4

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Number of Participants With Composite of the Following Events, Adjudicated Centrally: Stroke, Transient Ischemic Attack, Non-central Nervous System Systemic Embolism, Myocardial Infarction and Cardiovascular Death

Stroke, TIA, Non-CNS Embolism, MI and cardiovascular death were adjudicated and confirmed by Clinical Endpoints Committee (CEC). Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Cardiovascular death included death in subjects with non-valvular atrial fibrillation (AF). Number of subjects with composite events were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)5
Vitamin K Antagonist (VKA)5

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Number of Participants With Composite of Strokes, Transient Ischemic Attacks, Non-central Nervous System Systemic Embolisms, Myocardial Infarctions and All-cause Mortality

Stroke, TIA, Non- CNS systemic embolism, MI and all-cause mortality were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. TIA including information if with or without matching lesion. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). MI was assessed based on either cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. All-cause mortality included vascular death and non-vascular death. Number of subjects with composite events were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)6
Vitamin K Antagonist (VKA)6

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Number of Participants With Strokes

All events were adjudicated and confirmed by a CEC blinded to treatment. Stroke included hemorrhagic (Stroke with local collections of intraparenchymal blood. Subarachnoid hemorrhage, subdural hemorrhage, and epidural hemorrhage were excluded), ischemic infarction (Stroke without focal collection of intracranial blood) and unknown (No imaging data and anatomic findings were available). Number of subjects with strokes were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2
Vitamin K Antagonist (VKA)2

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Number of Participants With Transient Ischemic Attacks

All events were adjudicated and confirmed by a CEC blinded to treatment. Number of subjects with TIA were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0
Vitamin K Antagonist (VKA)0

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Number of Participants With Major Bleedings as Per Central Adjudication

Bleeding events were adjudicated and confirmed by CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the International Society on Thrombosis and Hemostasis (ISTH) criteria. Major bleeding was clinically overt bleeding associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or higher, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death. Number of subjects with confirmed adjudicated bleeding events occurring in greater than (>)1 total subjects were reported. (NCT01674647)
Timeframe: From randomization up to the date of the last dose of study drug + 2 days

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)6
Vitamin K Antagonist (VKA)4

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Number of Participants With Composite of Major and Non-major Bleeding Events

All events were adjudicated and confirmed by a CEC blinded to treatment. The CEC categorized the bleeding events as major or non-major. The bleeding events were defined per the ISTH criteria. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life. Number of subjects with clinically relevant major and non-major bleeding events were reported. (NCT01674647)
Timeframe: From randomization up to the date of the last dose of study drug + 2 days

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)33
Vitamin K Antagonist (VKA)14

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Number of Participants With Cardiovascular Deaths

All events were adjudicated and confirmed by a CEC blinded to treatment. Any death that was not clearly non-vascular (e.g., deaths due to spontaneous bleeding, myocardial infarction, stroke, cardiac failure, and arrhythmia). Number of subjects with cardiovascular deaths were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)4
Vitamin K Antagonist (VKA)2

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Number of Participants With All-cause Mortality

All events were adjudicated and confirmed by a CEC blinded to treatment. All-cause mortality included vascular death and non-vascular death. Number of subjects with all-cause mortality were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)5
Vitamin K Antagonist (VKA)3

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Number of Participants With Composite of Strokes and Non-central Nervous System Systemic Embolisms

Stroke and Non-CNS Embolism were adjudicated and confirmed by CEC. Stroke included hemorrhagic and ischemic infarction. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with composite events were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)2
Vitamin K Antagonist (VKA)3

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Number of Participants With Myocardial Infarctions

All events were adjudicated and confirmed by a CEC blinded to treatment. MI was assessed based onmeither cardiac biomarkers, new abnormal Q waves appeared on electrocardiogram for >= 2 leads, or autopsy confirmation. Number of subjects with MI were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)1
Vitamin K Antagonist (VKA)1

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Number of Participants With Non-central Nervous System Systemic Embolisms

All events were adjudicated and confirmed by a CEC blinded to treatment. Non CNS systemic embolism included emboli in peripheral arterial of the upper and lower extremities, ocular and retinal (pulmonary embolism and MI were excluded from the category). Number of subjects with non-CNS embolism were reported. (NCT01674647)
Timeframe: From randomization to the date of last dose of study drug +2 days for subjects who completed planned treatment or the earlier date [last planned dose, follow-up visit at the end of 30-day follow-up period] for subjects who prematurely stopped treatment

InterventionParticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939)0
Vitamin K Antagonist (VKA)1

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Anti-factor Xa Values at Specified Time Points

The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. (NCT01684423)
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

,,
Interventionmicrogram per liter (mcg/L) (Mean)
Day 15: pre-doseDay 15: 2 to 4 hours post-doseDay 15: 6 to 8 hours post-doseDay 31: 10 to 16 hours post-doseDay 31: 20 to 24 hours post-dose
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years31.55399.41577.92930.927NA
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years16.081185.481105.223NA16.038
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years8.136252.85368.670NA8.409

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Number of Subjects With Major and Clinically Relevant Non-Major Bleeding Events

"Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and:~associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or~leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or~occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or~contributing to death.~Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:~medical intervention, or~unscheduled contact (visit or telephone call) with a physician, or~cessation (temporary) of study treatment, or~discomfort for the child such as pain or~impairment of activities of daily life (such as loss of school days or hospitalization)." (NCT01684423)
Timeframe: From start of study drug administration until end of the 30-day treatment period

,,,,
InterventionParticipants (Number)
Major bleeding eventsClinically relevant non-major bleeding events
Comparator, Age: 12 - <18 Years00
Comparator, Age: 6 - < 12 Years00
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years01
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years03
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years00

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Number of Subjects With Symptomatic Recurrent Venous Thromboembolism

The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence of venous thrombosis was documented by the appropriate imaging test. (NCT01684423)
Timeframe: From start of study drug administration until end of the 30-day treatment period

InterventionParticipants (Number)
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years0
Comparator, Age: 12 - <18 Years0
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years0
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years0
Comparator, Age: 6 - < 12 Years0

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Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden

The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. Asymptomatic deterioration in thrombotic burden was documented by the appropriate imaging test and the results were classified as normalized, improved, no relevant change, deteriorated, not evaluable or not available. (NCT01684423)
Timeframe: Repeat imaging at the end of the 30 day treatment period

,,,,
InterventionParticipants (Number)
NormalizedImprovedNo relevant changeDeterioratedNot evaluableNot available
Comparator, Age: 12 - <18 Years200029
Comparator, Age: 6 - < 12 Years140011
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years492004
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years340004
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years281002

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points

Geometric and percentage geometric coefficient of variation (%CV) were reported. (NCT01684423)
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

,,
Interventionmicrogram per liter (mcg/L) (Geometric Mean)
Day 15: pre-doseDay 15: 2 to 4 hours post-doseDay 15: 6 to 8 hours post-doseDay 31: 10 to 16 hours post-doseDay 31: 20 to 24 hours post-dose
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years41.6025119.2201100.599243.5223NA
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years20.4822219.6933124.6723NA21.3252
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years7.4367240.631996.8051NA9.4654

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Change From Baseline in Prothrombin Time at Specified Time Points

Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. (NCT01684423)
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

,,
Interventionseconds (Mean)
Day 15: 2 to 4 hours post-doseDay 15: 6 to 8 hours post-doseDay 31: 10 to 16 hours post-doseDay 31: 20 to 24 hours post-dose
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years3.1471.9840.156NA
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years8.9644.218NA-0.082
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years9.0832.817NA-0.327

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Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points

The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. (NCT01684423)
Timeframe: 0 hours (pre-dose) to 8 hours post-dose on Day 15 and 24 hours post-dose on Day 31

,,
Interventionseconds (Mean)
Day 15: 2 to 4 hours post-doseDay 15: 6 to 8 hours post-doseDay 31: 10 to 16 hours post-doseDay 31: 20 to 24 hours post-dose
Rivaroxaban (BAY59-7939) Suspension, BID, Age: 6 - <12 Years2.9951.858-0.483NA
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 12 - <18 Years10.9826.136NA1.345
Rivaroxaban (BAY59-7939) Tablet, OD, Age: 6 - <12 Years12.8185.900NA1.240

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Number of Days on Anticoagulation

Assess subject anticoagulant utilization and number of days on anticoagulation (NCT01706146)
Timeframe: up to 12 months

Interventiondays (Mean)
Non-Coumadin Oral Anticoagulant24.9

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Bleeding Incidence

To assess the bleeding incidence with implantable monitor-guided intermittent anticoagulation. (NCT01706146)
Timeframe: up to 12 months

Interventionparticipants (Number)
Non-Coumadin Oral Anticoagulant3

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Number of Participants With Non-Central Nervous System (Non-CNS) Systemic Embolism

The Non-CNS systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms, (example; trauma, atherosclerosis, instrumentation). (NCT01729871)
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

InterventionParticipants (Number)
Rivaroxaban0
Vitamin K Antagonist0

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Number of Participants With Vascular Death

Any death that was not clearly non-vascular. Examples of vascular death included deaths due to bleeding, Myocardial Infarction (MI), stroke, heart failure and arrhythmias. (NCT01729871)
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

InterventionParticipants (Number)
Rivaroxaban0
Vitamin K Antagonist1

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Number of Participants With Composite Endpoint of Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (Non-CNS) Systemic Embolism and Vascular Death

The composite endpoint include Myocardial Infarction (MI), Ischemic Stroke, Non-Central Nervous System (non-CNS) Systemic Embolism and Vascular Death. (NCT01729871)
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

InterventionParticipants (Number)
Rivaroxaban0
Vitamin K Antagonist2

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Number of Participants With Myocardial Infarction (MI)

The MI was defined as clinical symptoms consistent with myocardial ischemia and cardiac biomarker elevation greater than the site's upper limit of normal (ULN) or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram (ECG) or autopsy confirmation, OR Creatine kinase-muscle and brain subunit [or creatine kinase (CK) in the absence of CK-MB] greater than (>) 3 or 5 or 10 x ULN for samples obtained within 24 hours of the procedure if the baseline values were normal or at least a 50 percent (%) increase over elevated baseline values that were stable or decreasing or development of new pathological Q waves in at least 2 contiguous leads on the electrocardiogram. Symptoms of cardiac ischemia were not required. (NCT01729871)
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

InterventionParticipants (Number)
Rivaroxaban0
Vitamin K Antagonist0

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Number of Participants With Ischemic Stroke

Stroke was defined as a new, sudden, focal neurological deficit resulting from a presumed cerebrovascular cause that was not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or seizure. (NCT01729871)
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

InterventionParticipants (Number)
Rivaroxaban0
Vitamin K Antagonist1

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Number of Participants With Incidence of Post-Procedure Major Bleeding Events

Post-procedure major bleeding events include Thrombolysis in Myocardial Infarction (TIMI), International Society on Thrombosis and Haemostasis (ISTH) and Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) Severe/life threatening bleeding. (NCT01729871)
Timeframe: Up to 30 plus or minus (+-) 5 days after the catheter ablation procedure

,
InterventionParticipants (Number)
TIMI Major BleedingISTH Major BleedingGUSTO Severe/Life Threatening Bleeding
Rivaroxaban000
Vitamin K Antagonist010

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The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria in LTOLE Part

"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the primary safety outcome major bleeding was evaluated. LTOLE: long-term open-lable extension" (NCT01776424)
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding from COMPASS LTOLE initiation visit up until 2 days after the last treatment in LTOLE part was considered. The mean time in follow-up was 421 days.

InterventionParticipants (Count of Participants)
LTOLE Part: Rivaroxaban 2.5mg + Aspirin 100mg138

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The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria

"Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).~Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis." (NCT01776424)
Timeframe: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5mg + Aspirin 100mg288
Rivaroxaban 5mg + Aspirin Placebo255
Rivaroxaban Placebo + Aspirin 100mg170

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The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death in LTOLE Part

Count of participants from COMPASS LTOLE initiation visit to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. LTOLE: long-term open-lable extension (NCT01776424)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after from COMPASS LTOLE initiation visit up until last LTOLE part contact date was considered. The mean time in follow-up was 428 days.

InterventionParticipants (Count of Participants)
LTOLE Part: Rivaroxaban 2.5mg + Aspirin 100mg353

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The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death

Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5mg + Aspirin 100mg379
Rivaroxaban 5mg + Aspirin Placebo448
Rivaroxaban Placebo + Aspirin 100mg496

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The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death

Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5mg + Aspirin 100mg329
Rivaroxaban 5mg + Aspirin Placebo397
Rivaroxaban Placebo + Aspirin 100mg450

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The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death

Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5mg + Aspirin 100mg389
Rivaroxaban 5mg + Aspirin Placebo453
Rivaroxaban Placebo + Aspirin 100mg516

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All-cause Mortality in LTOLE Part

Count of participants from COMPASS LTOLE initiation visit to death by all cause were evaluated. LTOLE: long-term open-lable extension (NCT01776424)
Timeframe: For each participants, death by any cause after COMPASS LTOLE initiation visit up until the the last LTOLE part contact date was considered. The mean time in follow-up until that date was 428 days.

InterventionParticipants (Count of Participants)
LTOLE Part: Rivaroxaban 2.5mg + Aspirin 100mg282

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All-cause Mortality

Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis. (NCT01776424)
Timeframe: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5mg + Aspirin 100mg313
Rivaroxaban 5mg + Aspirin Placebo366
Rivaroxaban Placebo + Aspirin 100mg378

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Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding

TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 696, 706, 697)End of DAPT-1 Month (n= 0, 108, 113)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 350, 341)
Rivaroxaban 15 mg1.0NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)1.00.90.41.4
Vitamin K Antagonist (VKA)1.91.82.51.5

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Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent). (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 696, 706, 697)End of DAPT-1 Month (n= 0, 108,113)End of DAPT-6 Month (n= 0, 248,243)End of DAPT-12 Month (n= 0, 350,341)
Rivaroxaban 15 mg2.0NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)1.70.92.81.1
Vitamin K Antagonist (VKA)2.94.43.71.8

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Percentage of Participants With Stroke

The percentage of participants with the first occurrence of Stroke were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg1.2NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)1.41.92.40.6
Vitamin K Antagonist (VKA)12.701.2

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Percentage of Participants With Stent Thrombosis

The percentage of participants with the first occurrence of stent thrombosis were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg0.7NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)0.91.91.60
Vitamin K Antagonist (VKA)0.60.90.40.6

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Percentage of Participants With Myocardial Infarction

The percentage of participants with the first occurrence of Myocardial Infarction were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg2.7NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)2.42.82.82
Vitamin K Antagonist (VKA)30.92.54.1

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Percentage of Participants With Composite of Adverse Cardiovascular Events (Cardiovascular Death, Myocardial Infarction (MI) and Stroke)

Percentage of participants who experienced adverse cardiovascular events (cardiovascular death, myocardial Infarction (MI) and stroke) collectively, were assessed. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg5.9NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)5.15.66.54
Vitamin K Antagonist (VKA)5.24.53.76.5

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Percentage of Participants With Cardiovascular Death

The percentage of participants with the first occurrence of cardiovascular death were evaluated. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 694, 704, 695)End of DAPT-1 Month (n= 0, 108, 112)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 348, 340)
Rivaroxaban 15 mg2.2NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)21.92.41.7
Vitamin K Antagonist (VKA)1.61.81.61.5

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Percentage of Participants With Bleeding Requiring Medical Attention (BRMA)

A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. (NCT01830543)
Timeframe: Up to Month 12 and end of DAPT-Month 1, 6 and 12

,,
Interventionpercentage of participants (Number)
Up to Month 12 (n= 696, 706, 697)End of DAPT-1 Month (n= 0, 108, 113)End of DAPT-6 Month (n= 0, 248, 243)End of DAPT-12 Month (n= 0, 350, 341)
Rivaroxaban 15 mg13.4NANANA
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)14.416.712.914.9
Vitamin K Antagonist (VKA)19.918.62318.2

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Percentage of Participants With Clinically Significant Bleeding

Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event. (NCT01830543)
Timeframe: Up to Month 12

Interventionpercentage of participants (Number)
Rivaroxaban 15 mg15.7
Rivaroxaban 2.5 mg Twice Daily (BID)/15 mg Once Daily(QD)16.6
Vitamin K Antagonist (VKA)24.0

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Event Rate of Re-Hospitalization for Worsening of Heart Failure

Event rate of re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban17.24
Placebo17.45

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Event Rate of Either Fatal Bleeding or Bleeding Into a Critical Space With Potential for Permanent Disability

Event rate of either fatal bleeding or bleeding into critical space with potential for permanent disability were assessed. Fatal bleeding event was death within 7 days after a bleeding event which required hospitalization or met International Society on Thrombosis and Haemostasis(ISTH) major bleeding definition criteria. Fatal bleeding events included those met criteria in 3 categories: 1: Any ISTH major bleeding event consider primary cause of death by investigator; 2: Any ISTH major bleeding event not considered to be primary cause of death by investigator but resulted in death within 7 days;3: Any bleeding event resulted in hospital stay and death within 7 days. Bleeding into critical space with potential for permanent disability included 7 critical spaces: intracranial, intraspinal, intraocular. Event rate estimated based on time to first occurrence of event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to 227 Weeks

,
InterventionEvent rate per 100 patient-year (Number)
Fatal BleedingCritical Space Bleeding with Permanent Disability
Placebo0.220.48
Rivaroxaban0.220.32

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Event Rate of Bleeding Events That Requiring Hospitalization

Event rate of bleeding events and required Hospitalization were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to 227 Weeks

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban1.52
Placebo1.16

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Event Rate of All-Cause Mortality (ACM) or Re-Hospitalization for Worsening Heart Failure

Event rate of all-Cause Mortality (ACM) or re-Hospitalization for worsening heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban24.84
Placebo24.57

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Event Rate of All-Cause Mortality, Myocardial Infarction (MI), or Stroke

Event Rate of all-cause mortality (ACM), MI, or stroke were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 patient [pt]-year [yr]) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban13.44
Placebo14.27

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Event Rate of Cardio Vascular Death

Event rate of cardio vascular death were assessed. CV death included deaths due to spontaneous bleeding, MI, stroke, worsening HF and arrhythmias, death due to CV procedures and sudden death. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban9.46
Placebo9.96

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Event Rate of Cardio Vascular Death or Re-Hospitalization for Worsening of Heart Failure (RHHF)

Event rate of cardio vascular (CV) death or re-hospitalization for worsening of heart failure were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban23.32
Placebo23.46

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Event Rate of International Society on Thrombosis and Haemostasis (ISTH) Major Bleeding Event

Event rate of ISTH major bleeding event were assessed. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to 227 Weeks

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban2.04
Placebo1.21

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Event Rate of Re-Hospitalization for Cardio Vascular Events (RHCV)

Event rate due to cardio vascular events were assessed. Hospitalization for a CV Event required that participants be hospitalized (in-patient or emergency department) for greater than 24 hours and must have met the following criterion:Discharge summary with primary reason for admission listed as CV in nature (example, bleeding, arrhythmia, ACS, MI) other than HF which was captured in the HF re-hospitalization. Event rate estimated based on the time to the first occurrence of the event were reported in the study. Event Rate / (100 pt-yr) = 100*n/(total risk exposure), where n is the number of events. (NCT01877915)
Timeframe: Up to Global treatment end date (approximately 54 months)

InterventionEvent rate per 100 patient-year (Number)
Rivaroxaban13.30
Placebo14.04

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Number of Participants With Recurrent Thrombosis

Number of participants with recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

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PTS Assessment Completion

Percentage of participants who completed post-thrombotic syndrome assessments (NCT01999179)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant17

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Biomarker Sample Collection

Number of participants that completed sample collection for biomarker analysis to predict recurrent venous thrombosis (NCT01999179)
Timeframe: 1 year

Interventionparticipants (Number)
Low-molecular-weight Heparin or Direct Oral Anticoagulant7

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Number of Participants With Major Bleeding

Number of participants with major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant1

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Number of Participants With Post-thrombotic Syndrome

The number of participants with post-thrombotic syndrome 6 months after catheter removal in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation (NCT01999179)
Timeframe: 6 months after catheter removal

InterventionParticipants (Count of Participants)
Low-molecular-weight Heparin or Direct Oral Anticoagulant0

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The Number of Patients With Recurrent Ischemic Lesion

Recurrent ischemic lesion confirmed by relevant neuroimagings (NCT02042534)
Timeframe: at 1 month

InterventionParticipants (Number)
Rivaroxaban28
Warfarin31

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Length of Hospitalization

Time to event will be calculated (NCT02042534)
Timeframe: at 1month

Interventiondays (Mean)
Rivaroxaban4.6
Warfarin5.6

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Number of Participants With Intracranial Bleeding and/or Recurrent Ischemic Lesion as Confirmed by MRI Imaging

"Intracranial bleeding: symptomatic hemorrhage confirmed by CT or MRI or asymptomatic hemorrhage on follow-up GRE or SWI imaging at 1 month~Recurrent ischemic lesion: symptomatic ischemic stroke confirmed by relevant neuroimagings or asymptomatic recurrent ischemic lesion on follow-up or FLAIR imaging at 1 month" (NCT02042534)
Timeframe: 1 month after randomization

InterventionParticipants (Number)
Rivaroxaban47
Warfarin48

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Number of Participants With Modified Rankin Score of 0 or 1 at Week 4

"modified Rankin Score~0 : No symptoms at all~: No significant disability despite symptoms; able to carry out all usual duties and activities~: Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance~: Moderate disability; requiring some help, but able to walk without assistance~: Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance~: Severe disability; bedridden, incontinent and requiring constant nursing care and attention~: Dead" (NCT02042534)
Timeframe: at 1 month

Interventionparticipants (Number)
Rivaroxaban79
Warfarin64

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The Number of Patients With Intracranial Bleeding

Intracranial bleeding confirmed by relevant neuroimagings (NCT02042534)
Timeframe: at 1 month

InterventionParticipants (Number)
Rivaroxaban30
Warfarin25

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Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism

"The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.~Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant." (NCT02064439)
Timeframe: Up to 12 months, at least 6 months

,,
Interventionparticipants (Number)
CompositeSymptomatic recurrent Deep vein thrombosis (DVT)Symptomatic recurrent PEDeath (PE)Death (unexplained and PE cannot be ruled out)
Acetylsalicylic (ASA) 100 mg, OD50291911
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD138500
Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD179602

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Number of Participants With First Treatment-emergent Major Bleeding

"The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.~Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant." (NCT02064439)
Timeframe: Up to 12 months, at least 6 months

,,
Interventionparticipants (Number)
Any major bleedingFatal bleedingNon-fatal critical organ bleedNon-fatal non-critical organ bleeding
Acetylsalicylic (ASA) 100 mg, OD3111
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD5023
Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD6141

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Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days

The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days. (NCT02064439)
Timeframe: Up to 12 months, at least 6 months

Interventionparticipants (Number)
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD12
Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD17
Acetylsalicylic (ASA) 100 mg, OD12

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Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism

The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant. (NCT02064439)
Timeframe: Up to 12 months, at least 6 months

,,
Interventionparticipants (Number)
CompositeIschemic strokeNon-CNS systemic embolismMyocardial infarctionSymptomatic recurrent DVTSymptomatic recurrent PEDeath (PE)Death (unexplained and PE cannot be ruled out)Death (cardiovascular: myocardial infarction)Death (cardiovascular: ischemic stroke)
Acetylsalicylic (ASA) 100 mg, OD5621429181100
Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD18410850000
Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD19201960100

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Change From Baseline to Week 4 in D-Dimer

Assay for D--dimer is performed using commercially available enzyme-linked immunosorbent assay (ELISA). (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionng/mL (Mean)
Rivaroxaban-471
Placebo-1035

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Change From Baseline to Week 4 in AH

Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: hyperemia area (AH) (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionperfusion units*seconds (Mean)
Rivaroxaban128
Placebo-1189

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Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)

Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA). (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionpg/mL (Mean)
Rivaroxaban40.9
Placebo10.7

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Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)

Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA). (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionpg/mL (Mean)
Rivaroxaban-1.1
Placebo-0.54

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Change From Baseline to Week 4 in RF

Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: rest flow (RF) (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionperfusion units (Mean)
Rivaroxaban0.29
Placebo-0.62

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Change From Baseline to Week 4 in TAT

Assay for thrombin antithrombin (TAT) complexes performed using commercially available enzyme-linked immunosorbent assay (ELISA). (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionug/mL (Mean)
Rivaroxaban-34.44
Placebo0.35

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Change From Baseline to Week 4 in TH1

Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to half before hyperemia (TH1) (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionseconds (Mean)
Rivaroxaban0.84
Placebo-0.51

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Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2

Interleukin-2 (IL-2) was measured using Luminex MAP technology at the UNC core facility (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionpg/mL (Mean)
Rivaroxaban-1.14
Placebo0.36

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Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8

Interleukin-8 (IL-8) was measured using Luminex MAP technology at the UNC core facility (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionpg/mL (Mean)
Rivaroxaban0.95
Placebo-4.08

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Change From Baseline to Week 4 in TM

Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to max (TM) (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionseconds (Mean)
Rivaroxaban-0.97
Placebo-2.01

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Change in Ratio From Baseline to Week 4 in AH/AO

Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variables measured: hyperemia area (AH) and occlusion area (AO) (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionratio of AH to AO (Mean)
Rivaroxaban0.05
Placebo-0.81

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Change From Baseline to Week 4 in PF

Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: peak flow (PF) (NCT02072668)
Timeframe: Baseline, 4 weeks

Interventionperfusion units (Mean)
Rivaroxaban3.14
Placebo-12.62

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Event Rate Based on Time From Randomization to First Occurrence of All-Cause Mortality (ACM) Adjudicated by CEC

Event rate based on time from randomization to first occurrence of ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg1.19
Placebo1.49

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Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE, Myocardial Infarction (MI), Non-Hemorrhagic Stroke, and Cardiovascular (CV) Death Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE (lower extremity DVT and non-fatal PE), MI, non-hemorrhagic stroke, and CV death (death due to a known CV cause and death in which a CV cause cannot be ruled out; by this definition, a VTE-related death was considered a CV death) as adjudicated by CEC was reported. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg1.58
Placebo2.03

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Event Rate Based on Time From Randomization to the First Occurrence of a Composite of Symptomatic VTE and All-Cause Mortality (ACM) Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a composite of symptomatic VTE and ACM (adjudicated by CEC) was assessed. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg1.31
Placebo1.80

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Event Rate Based on Time From Randomization to the First Occurrence of a Symptomatic Venous Thromboembolism Event (VTE) Adjudicated by CEC

Event rate based on time from randomization to the first occurrence of a symptomatic VTE (adjudicated by CEC) was assessed. Symptomatic VTE included lower extremity DVT and non-fatal PE. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or Day 45. (NCT02111564)
Timeframe: Up to Day 45

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg0.19
Placebo0.42

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Event Rate Based on Time From Randomization to the First Occurrence of Major Bleeding Adjudicated by CEC

A major bleeding event was defined using validated International Society on Thrombosis and Haemostasis (ISTH) bleeding criteria. A major bleeding event was defined as overt bleeding that was associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or a critical site defined as intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or a fatal outcome. Event rate was defined as number of events per 100 participants in 45 days of follow up. Participants who did not have events were censored on the minimum of last visit before or on death, or last dose + 2 days. (NCT02111564)
Timeframe: From randomization to 2 days after the last dose (Day 45)

InterventionEvents per 100 participants in 45 days (Number)
Rivaroxaban 10 mg or 7.5 mg0.28
Placebo0.15

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Clinically Relevant Non-major (CRNM) Bleeding

"Clinically relevant non-major (CRNM) bleeding defined as at least one of the following:~spontaneous skin hematoma of at least 25 cm~spontaneous nose bleeding of more than 5 minutes duration~macroscopic hematuria, either spontaneous or, if associated with an intervention, lasting more than 24 hours~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding for more than 5 minutes~bleeding leading to hospitalization and/or requiring surgical treatment~bleeding leading to a transfusion of less than 2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator" (NCT02164578)
Timeframe: Week 1 to week 52

Interventionevents (Number)
Rivaroxaban6
Aspirin1

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Clinically Relevant Non-major (CRNM) Bleeding

"Clinically relevant non-major (CRNM) bleeding defined as at least one of the following:~spontaneous skin hematoma of at least 25 cm~spontaneous nose bleeding of more than 5 minutes duration~macroscopic hematuria, either spontaneous or, if associated with an intervention, lasting more than 24 hours~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding for more than 5 minutes~bleeding leading to hospitalization and/or requiring surgical treatment~bleeding leading to a transfusion of less than 2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator" (NCT02164578)
Timeframe: Week 1 to week 20

Interventionevents (Number)
Rivaroxaban11
Aspirin1

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Change in Skin Blood Flow

Change in skin blood flow for assessment of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF) (NCT02164578)
Timeframe: Baseline to week 52

Interventionarbitrary units (Mean)
Rivaroxaban-7.3
Aspirin5.8

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Change in Skin Blood Flow

Change in skin blood flow for assessment of peripheral skin microcirculatory function (measured by laserdopplerfluxmetry; LDF) (NCT02164578)
Timeframe: Baseline to week 20

Interventionarbitrary units (Mean)
Rivaroxaban3.47
Aspirin-6.01

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Change in Pulse Wave Velocity

Change in pulse wave velocity as a marker of arterial stiffness (measured by IEM Mobil-O-Graph) (NCT02164578)
Timeframe: Baseline and week 52

Interventionm/s (Mean)
Rivaroxaban0.24
Aspirin0.51

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Change in Pulse Wave Velocity

Change in pulse wave velocity as a marker for arterial stiffness (measured by IEM Mobil-O-Graph) (NCT02164578)
Timeframe: Baseline to week 20

Interventionm/s (Mean)
Rivaroxaban0.02
Aspirin0.14

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Change in Post-ischemic Forearm Blood Flow

Difference of change in post-ischemic forearm blood flow measured by venous occlusion plethysmography at baseline and after 52 weeks treatment with rivaroxaban or aspirin. (NCT02164578)
Timeframe: Baseline and week 52

Interventionml/100ml (Mean)
Rivaroxaban6.11
Aspirin1.56

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Change in Post-ischemic Forearm Blood Flow

"Change of maximal postischemic forearm blood flow during reactive hyperaemia after 5 min of forearm ischemia (FBF max. ml/100ml).~Difference of change in post-ischemic forearm blood flow measured by venous occlusion plethysmography at baseline and after 20 weeks treatment with rivaroxaban or aspirin." (NCT02164578)
Timeframe: Baseline and week 20

Interventionml/100ml (Mean)
Rivaroxaban3.60
Aspirin1.00

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Major Bleeding

Major bleeding defined as clinically overt and associated with one of the following: 1) reduction of hemoglobin level of 2 g/L or 2) required transfusion of at least 2 units of red cells or, involved a critical organ or was fatal, in accordance with the recommendation of the International Society on Thrombosis and Hemostasis (ISTH). (NCT02164578)
Timeframe: Week 1 to week 52

Interventionevents (Number)
Rivaroxaban0
Aspirin0

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Major Bleeding

Major bleeding defined as clinically overt and associated with one of the following: 1) reduction of hemoglobin level of 2 g/L or 2) required transfusion of at least 2 units of red cells or, involved a critical organ or was fatal, in accordance with the recommendation of the International Society on Thrombosis and Hemostasis (ISTH). (NCT02164578)
Timeframe: Week 1 to week 20

Interventionevents (Number)
Rivaroxaban1
Aspirin0

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=154Day 30 (2.5-4h) n=149Day 60 (2-8h) n=153
Rivaroxaban, Aged 12-<181.171.381.33

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=1Day 30 (2.5-4h) n=34Day 60 (2-8h) n=32
Rivaroxaban, Aged 2-<60.991.361.33

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (2.5-4h) n=1Day 60 (2-8h) n=2
Rivaroxaban, Aged 0.5-<21.411.05

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Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Main Treatment Period

The Central independent adjudication committee (CIAC) classified bleeding as: Major bleeding defined as overt bleeding and: · associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact (visit or telephone call) with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life (such as loss of school days or hospitalization). (NCT02234843)
Timeframe: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

InterventionPercentage of participants (Number)
Rivaroxaban Group3
Comparator Group1.9
Rivaroxaban, Aged 12-<181.7
Rivaroxaban, Aged 6-<123.0
Rivaroxaban, Aged 2-<66.5
Rivaroxaban, Aged 0.5-<24.8
Rivaroxaban, Aged Birth-<0.56.7
Comparator, Aged 12-<182.2
Comparator, Aged 6-<120.0
Comparator, Aged 2-<60.0
Comparator, Aged 0.5-<211.1
Comparator, Aged Birth-<0.50.0

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Incidence Rates of the Composite of All Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging During the Main Treatment Period

The secondary efficacy outcome defined as the composite of all symptomatic recurrent venous thromboembolism and asymptomatic deterioration on repeat imaging as assessed by central independent adjudication committee. (CIAC) Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population (NCT02234843)
Timeframe: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

InterventionPercentage of participants (Number)
Rivaroxaban, Aged 12-<182.2
Rivaroxaban, Aged 6-<120.0
Rivaroxaban, Aged 2-<62.1
Rivaroxaban, Aged 0.5-<20.0
Rivaroxaban, Aged Birth-<0.50.0
Comparator, Aged 12-<184.3
Comparator, Aged 6-<122.9
Comparator, Aged 2-<64.5
Comparator, Aged 0.5-<20.0
Comparator, Aged Birth-<0.50.0

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Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-1.5h) n=141Day 30 (2.5-4h) n=164Day 60 (2-8h) n=167Day 90 (20-24h) n=58
Rivaroxaban, Aged 12-<18164.46254.66255.4062.12

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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period

The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population (NCT02234843)
Timeframe: During the main study treatment period (i.e., 3 months, except for children with central venous catheter venous thromboembolism (CVC-VTE) aged <2 years for whom it was 1 month)

InterventionPercentage of participants (Number)
Rivaroxaban Group1.2
Comparator Group3.0

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Ctrough,ss in Plasma

Ctrough,ss refers to the drug concentration at the end of the dosage interval at steady state (NCT02234843)
Timeframe: 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours(one sampling interval in steady state)

Interventionmicrogram per liter (Geometric Mean)
Rivaroxaban, Aged 12-<1820.7
Rivaroxaban, Aged 6-<1221.4
Rivaroxaban, Aged 2-<631.6
Rivaroxaban, Aged 0.5-<222.9
Rivaroxaban, Aged Birth-<0.518.5

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Cmax,ss in Plasma

Maximum drug concentration in measured matrix at steady state during a dosage interval (NCT02234843)
Timeframe: 0 hours to 24 hours, 0 hours to 12 hours or 0 hours to 8 hours (one dosing interval in steady state)

Interventionmicrogram per liter (Geometric Mean)
Rivaroxaban, Aged 12-<18237
Rivaroxaban, Aged 6-<12184
Rivaroxaban, Aged 2-<6182
Rivaroxaban, Aged 0.5-<2136
Rivaroxaban, Aged Birth-<0.5119

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=18Day 30 (2.5-4h) n=20Day 60 (2-8h) n=20
Rivaroxaban, Aged 6-<121.461.671.52

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AUC(0-24)ss in Plasma

AUC(0-24)ss: Area under the concentration vs. time curve from time 0 to 24 hours at steady state. (NCT02234843)
Timeframe: over 24 hours

Interventionmicrogram*hour per liter (Geometric Mean)
Rivaroxaban, Aged 12-<182120
Rivaroxaban, Aged 6-<121960
Rivaroxaban, Aged 2-<62380
Rivaroxaban, Aged 0.5-<21840
Rivaroxaban, Aged Birth-<0.51590

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 12-<18 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=156Day 30 (2.5-4h) n=150Day 60 (2-8h) n=156
Rivaroxaban, Aged 12-<181.291.571.52

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Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period

Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life. (NCT02234843)
Timeframe: During extended treatment period: up to month 12.

,,,,,
InterventionPercentage of participants (Number)
Extension 1 (month 3 to 6)Extension 2 (month 6 to 9)Extension 3 (month 9 to 12)
Comparator, Aged 12-<180.05.30.0
Comparator, Aged 2-<60.00.00.0
Comparator, Aged 6-<120.00.00.0
Rivaroxaban, Aged 12-<181.12.60.0
Rivaroxaban, Aged 2-<60.00.00.0
Rivaroxaban, Aged 6-<120.00.00.0

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-3h) n=4Day 60 (2-6h) n=4
Rivaroxaban, Aged 2-<61.501.13

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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period

Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population. (NCT02234843)
Timeframe: During extended treatment period: up to month 12.

,,,,,
InterventionPercentage of participants (Number)
Extension 1 (month 3 to 6)Extension 2 (month 6 to 9)Extension 3 (month 9 to 12)
Comparator, Aged 12-<182.25.30.0
Comparator, Aged 2-<60.00.00.0
Comparator, Aged 6-<120.00.00.0
Rivaroxaban, Aged 12-<180.02.60.0
Rivaroxaban, Aged 2-<60.00.00.0
Rivaroxaban, Aged 6-<120.00.00.0

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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During Extended Treatment Period

Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant in the specific subgroup entered in the specific optional extension period, no analysis of an outcome was possible., The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference Population. (NCT02234843)
Timeframe: During extended treatment period: up to month 12.

,,
InterventionPercentage of participants (Number)
Extension 1 (month 3 to 6)
Comparator, Aged 0.5-<20.0
Comparator, Aged Birth-<0.50.0
Rivaroxaban, Aged Birth-<0.50.0

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Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (2.5-4h) n=37Day 60 (2-8h) n=36Day 90 (10-16h) n=18
Rivaroxaban, Aged 2-<6177.78150.0354.40

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Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-1.5h) n=1Day 30 (2.5-4h) n=2Day 60 (2-8h) n=4
Rivaroxaban, Aged 0.5-<2247.54160.71121.09

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Anti-Xa Values: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 16 hours on Day 90

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-1.5h) n=37Day 30 (2.5-4h) n=36Day 60 (2-8h) n=35Day 90 (10-16h) n=20
Rivaroxaban, Aged 6-<1296.82139.10126.5347.49

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Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-3h) n=10Day 60 (2-6h) n=5
Rivaroxaban, Aged Birth-<0.5118.12228.03

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Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, and up to 16 hours on Day 90

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-3h) n=4Day 60 (2-6h) n=4Day 90 (10-16h) n=1
Rivaroxaban, Aged 2-<6209.67140.4662.56

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Anti-Xa Values: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day 30, up to 6 hours post dose on Day 60, up to 16 hours on Day 90 and follow-up up to 30 days

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-3h) n=12Day 30 (2-6h) n=11Day 90 (10-16h) n=3Follow-up n=1
Rivaroxaban, Aged 0.5-<2111.35147.2423.4071.30

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Anti-Xa Values: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years

This is a method for measuring the inhibition of Factor Xa activity determined by an ex vivo using a photometric method. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, up to 8 hours post dose on Day 60, and up to 24 hours on Day 90

Interventionmicrogram per liter (mcg/L) (Mean)
Day 30 (0.5-1.5h) n=22Day 30 (2.5-4h) n=23Day 60 (2-8h) n=22Day 90 (20-24h) n=9
Rivaroxaban, Aged 6-<12206.89263.24243.4527.39

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Incidence Rates of All Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period

The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Incidence = number of events / number at risk, where: number of events = number of subjects having the event in the time window. number at risk = number of subjects in reference population (NCT02234843)
Timeframe: During the main study treatment period (i.e., 3 months, except for children with CVC-VTE aged <2 years for whom it was 1 month)

InterventionPercentage of participants (Number)
Rivaroxaban, Aged 12-<182.2
Rivaroxaban, Aged 6-<120.0
Rivaroxaban, Aged 2-<60.0
Rivaroxaban, Aged 0.5-<20.0
Rivaroxaban, Aged Birth-<0.50.0
Comparator, Aged 12-<183.3
Comparator, Aged 6-<122.9
Comparator, Aged 2-<64.5
Comparator, Aged 0.5-<20.0
Comparator, Aged Birth-<0.50.0

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60

Interventionratios (Mean)
Day 30 (0.5-3h) n=9Day 60 (2-6h) n=7
Rivaroxaban, Aged 0.5-<21.252.00

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 2-<6 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-3h) n=4Day 60 (2-6h) n=4
Rivaroxaban, Aged 2-<61.871.32

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day30, and up to 6 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-3h) n=11Day 60 (2-6h) n=4
Rivaroxaban, Aged Birth-<0.51.351.45

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Prothrombin Time (PT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years

Prothrombin time (PT) is a global clotting test assessing the extrinsic pathway of the blood coagulation cascade. The test is sensitive for deficiencies of Factors II, V, VII, and X, with sensitivity being best for Factors V, VII, and X and less pronounced for Factor II. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=33Day 30 (2.5-4h) n=33Day 60 (2-8h) n=34
Rivaroxaban, Aged 6-<121.171.261.21

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 2-<6 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=1Day 30 (2.5-4h) n=32Day 60 (2-8h) n=29
Rivaroxaban, Aged 2-<60.901.291.23

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension) in the Age Group 0.5-<2 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. 'NA' denotes the data that cannot be calculated. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (2.5-4h) n=1Day 60 (2-8h) n=2
Rivaroxaban, Aged 0.5-<21.131.10

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Twice Daily (Suspension and Tablet) in the Age Group 6-<12 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=30Day 30 (2.5-4h) n=30Day 60 (2-8h) n=31
Rivaroxaban, Aged 6-<121.111.151.18

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group Birth-<0.5 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-3h) n=9Day 60 (2-6h) n=3
Rivaroxaban, Aged Birth-<0.51.311.21

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Incidence Rates of the Composite of Treatment Emergent Overt Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding During Extended Treatment Period

Incidence rates for all children except those aged < 2 years with catheter-related thrombosis. If no participant entered in the specific optional extension period, no analysis of an outcome was possible. The CIAC classified bleeding as: Major bleeding defined as overt bleeding and: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Clinically relevant non-major bleeding defined as overt bleeding not meeting the criteria for major bleeding, but associated with: medical intervention, or unscheduled contact with a physician, or (temporary) cessation of study treatment, or discomfort for the child such as pain or impairment of activities of daily life. (NCT02234843)
Timeframe: During extended treatment period: up to month 12.

,,
InterventionPercentage of participants (Number)
Extension 1 (month 3 to 6)
Comparator, Aged 0.5-<20.0
Comparator, Aged Birth-<0.50.0
Rivaroxaban, Aged Birth-<0.50.0

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Three Times Daily (Suspension) in the Age Group 0.5-<2 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 3 hours post dose on Day 30, and up to 6 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-3h) n=9Day 60 (2-6h) n=6
Rivaroxaban, Aged 0.5-<21.201.10

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Activated Partial Thromboplastin Time (aPTT) Ratios to Baseline: Rivaroxaban Administered Once Daily (Suspension and Tablet) in the Age Group 6-<12 Years

The aPTT is a screening test for the intrinsic pathway and is sensitive for deficiencies of Factors I, II, V,VIII, IX, X, XI and XII. The initial read-out is in seconds. (NCT02234843)
Timeframe: Up to 4 hours post dose on Day 30, and up to 8 hours post dose on Day 60

Interventionratio (Mean)
Day 30 (0.5-1.5h) n=17Day 30 (2.5-4h) n=17Day 60 (2-8h) n=19
Rivaroxaban, Aged 6-<121.271.391.24

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Number of Subjects With the Composite of All Symptomatic Recurrent Venous Thromboembolism During the 30 Days Post-study Treatment Period (i.e. >2 and ≤ 30 Days After Stop of Study Medication)

The Central independent adjudication committee (CIAC) classified symptomatic recurrent venous thromboembolism (VTE). Age group with primary efficacy outcome was reported. (NCT02234843)
Timeframe: More than 2 and up to 30 days after stop of study medication

InterventionParticipants (Count of Participants)
Rivaroxaban, Aged 12-<180
Comparator, Aged 12-<182
Rivaroxaban, Aged 6-<120
Rivaroxaban, Aged 2-<60
Rivaroxaban, Aged 0.5-<20
Rivaroxaban, Aged Birth-<0.50
Comparator, Aged 6-<120
Comparator, Aged 2-<60
Comparator, Aged 0.5-<20
Comparator, Aged Birth-<0.50

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Number of Participants With 2 Class Improvement on the Rutherford Scale

"Clinical improvement defined as cumulative improvement of 2 classes of the Rutherford scale without the need for repeated TLR in surviving patients.~There are seven stages to consider. the lower the score the less severe the disease or condition.~Rutherford Scale:~Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.~Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene" (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin5
Rivaroxaban Plus Aspirin8

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Overall Survival

Overall survival. How long a patient is alive following the intervention. (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin11
Rivaroxaban Plus Aspirin9

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Reintervention, Above Ankle Amputation and Restenosis (RAS)

The primary outcome is a combined endpoint consisting of any Reintervention (surgical procedures to revascularize), Above ankle amputation and restenosis(recurrence of blockage in the vein) (RAS) at one year (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin7
Rivaroxaban Plus Aspirin4

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The Number of Patients Requiring Target Lesions Revascularization Between Day 1 and the Final Visit (TLR)

Target lesion revascularization (TLR) between day 1 and final visit (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin2
Rivaroxaban Plus Aspirin1

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TVR

Target vessel revascularization (TVR between day 1 and final visit) (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin2
Rivaroxaban Plus Aspirin1

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Minor Bleeding

Cumulative clinically relevant or minor bleeding between day 1 and day 90 (NCT02260622)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin1

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Major Bleeding

Cumulative rate of major bleeding between day 1 and day 90 (NCT02260622)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin0

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MACE

Cumulative rate of major adverse cardiovascular events between day 1 and final visit (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin0

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Peri-procedure Death

The number of patients that die within 30 days of the revascularization procedure. (NCT02260622)
Timeframe: 30 days

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin0
Rivaroxaban Plus Aspirin0

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Event-free Survival

Event-free survival How long a patient is alive without the need for any further intervention or vascular events. (NCT02260622)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Clopidogrel Plus Aspirin4
Rivaroxaban Plus Aspirin4

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Number of Subjects With Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging

The occurrence of asymptomatic deterioration in thrombotic burden was summarized by age group. At the end of the 30-day treatment period, a repeat imaging of the thrombus was performed. The images of the index event and repeat imaging were adjudicated by the central independent adjudication committee (CIAC). The thrombotic burden at the time of the index event was compared to the thrombotic burden at the time of repeat imaging. The outcome of the adjudication was classified as normalized, improved, no relevant change, deteriorated, or not evaluable. Due to missing repeated imaging, thrombotic burden assessments were not done in some subjects. (NCT02309411)
Timeframe: At the end of the 30-day treatment period

,
InterventionParticipants (Count of Participants)
NormalizedImprovedNo relevant changeDeterioratedNot evaluableNot availableMissing
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years4430004
Rivaroxaban, Suspension, BID, Age: 2-6 Years61510003

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Number of Subjects With Major Bleeding and Clinically Relevant Non-Major Bleeding Events

"Major bleeding is defined as overt bleeding and:~associated with a fall in hemoglobin of 2 gram/decilitre (g/dL) or more, or~leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or~occurring in a critical site, for example (e.g.) intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or~contributing to death.~Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with:~medical intervention, or~unscheduled contact (visit or telephone call) with a physician, or~cessation (temporary) of study treatment, or~discomfort for the child such as pain or~impairment of activities of daily life (such as loss of school days or hospitalization)." (NCT02309411)
Timeframe: During or within 2 days after stop of study treatment (up to 32 days)

,
InterventionParticipants (Count of Participants)
Major bleeding eventsClinically relevant non-major bleeding events
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years00
Rivaroxaban, Suspension, BID, Age: 2-6 Years00

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Number of Subjects With Symptomatic Recurrent Venous Thromboembolism

Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. The occurrence of recurrent venous thromboembolism was summarized by age group. Symptomatic recurrence, which is the composite of deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE), and fatal PE of venous thrombosis, had to be documented using appropriate (repeat) imaging test. (NCT02309411)
Timeframe: From start of the study treatment up to 30-days post study treatment period (approximately 60 days)

InterventionParticipants (Count of Participants)
Rivaroxaban, Suspension, BID, Age: 2-6 Years0
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years0

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Anti-factor Xa Values at Specified Time Points

The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. The anti-factor Xa assay is designed to measure plasma heparin, low molecular weight heparin and other anticoagulants. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. (NCT02309411)
Timeframe: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)

,
Interventionmicrogram per liter (mcg/L) (Mean)
Day 1: 2.5-4 hours post-doseDay 15: 2-8 hours post-doseDay 30: 10-16 hours post-dose
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years87.831131.36916.952
Rivaroxaban, Suspension, BID, Age: 2-6 Years128.457103.10519.069

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Change From Baseline in Activated Partial Thromboplastin Time at Specified Time Points

The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway. Day 30 (10-16 hours post-dose) was considered as a baseline. (NCT02309411)
Timeframe: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)

,
InterventionSeconds (Mean)
Day 1: 2.5-4 hours post-doseDay 15: 2-8 hours post-dose
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years-3.47921
Rivaroxaban, Suspension, BID, Age: 2-6 Years6.4552.814

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Change From Baseline in Prothrombin Time at Specified Time Points

Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. Day 30 (10-16 hours post-dose) was considered as a baseline. (NCT02309411)
Timeframe: Day 1 (2.5-4 hours post-dose); Day 15 (2-8 hours post-dose); Day 30 (10-16 hours post-dose)

,
InterventionSeconds (Mean)
Day 1: 2.5-4 hours post-doseDay 15: 2-8 hours post-dose
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years2.5144.764
Rivaroxaban, Suspension, BID, Age: 2-6 Years2.7772.586

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Specified Time Points

Concentration of rivaroxaban in plasma was measured at Day 1, 15 and 30 at specified time points. In the below table, 'n' signifies those subjects who were evaluable for this measure at given time points for each group. Geometric mean and percentage geometric coefficient of variation (%CV) were reported. (NCT02309411)
Timeframe: Day 1 (30-90 minutes, 2.5-4 hours post-dose); Day 15 (2-8 hours post-dose) and Day 30 (10-16 hours post-dose)

,
Interventionmicrogram per liter (mcg/L) (Geometric Mean)
Day 1: 30-90 minutes post-doseDay 1: 2.5-4 hours post-doseDay 15: 2-8 hours post-doseDay 30: 10-16 hours post-dose
Rivaroxaban Suspension, BID, Age: 6 Months-2 Years68.007276.537161.38175.9545
Rivaroxaban, Suspension, BID, Age: 2-6 Years72.8494108.6053112.357819.8714

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Incidence Rate of Clinically Relevant Non-Major Bleeding Events

Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD3.52
Acetylsalicylic Acid 100 mg OD2.32

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Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction

Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD6.20
Acetylsalicylic Acid 100 mg OD5.85

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Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)

Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD1.82
Acetylsalicylic Acid 100 mg OD0.67

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Incidence Rate of All-Cause Mortality

All-cause mortality includes all deaths of participants due to any cause. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD1.88
Acetylsalicylic Acid 100 mg OD1.50

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Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction

"Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to moderate disability (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from moderately severe disability (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging." (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

,
Interventionevent/100 participant-years (Number)
StrokeIschemic strokeDisabling strokeCV death(includes death due to hemorrhage)Myocardial infarction
Acetylsalicylic Acid 100 mg OD4.714.560.840.660.67
Rivaroxaban 15 mg OD5.114.711.200.990.49

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Incidence Rate of the Composite Efficacy Outcome (Adjudicated)

Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD5.14
Acetylsalicylic Acid 100 mg OD4.78

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Incidence Rate of Life-Threatening Bleeding Events

Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD1.02
Acetylsalicylic Acid 100 mg OD0.43

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Incidence Rate of Intracranial Hemorrhage

Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. (NCT02313909)
Timeframe: From randomization until the efficacy cut-off date (median 326 days)

Interventionevent/100 participant-years (Number)
Rivaroxaban 15 mg OD0.70
Acetylsalicylic Acid 100 mg OD0.35

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Change in the Levels of C-Reactive Protein at 3 Months

C-Reactive (CRP) was measured using high sensitivity. (NCT02331095)
Timeframe: 3 Months

,
Interventionmg/L (Median)
Enrollment3 Months
Anticoagulation5.53.9
Atorvastatin + Anticoagulation7.05.1

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Change in Low-Density Lipoproteins (LDL) at 3 Months

(NCT02331095)
Timeframe: 3 Months

,
Interventionmg/dL (Mean)
Enrollment3 Months
Anticoagulation123.8115.9
Atorvastatin + Anticoagulation116.976.1

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The Rate of Residual (Chronic) Vein Obstruction by Doppler Ultrasound

Residual venous obstruction was assed by Doppler Ultrasonography. Residual chronic DVT (to any degree) was reported. (NCT02331095)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Anticoagulation8
Atorvastatin + Anticoagulation8

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The Reduction of Peak Thrombin Concentration

"Determine the reduction of thrombin peak concentration measured by Thrombin Generation Assay (TGA) at 3 months in the anticoagulation +atorvastatin arm as compared to the anticoagulation arm." (NCT02331095)
Timeframe: 3 Months

,
InterventionnM (Median)
Enrollment3 Months
Anticoagulation3754
Atorvastatin + Anticoagulation6748

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The Reduction of Endogenous Thrombin Potential

"Determine the reduction of endogenous thrombin potential measured by Thrombin Generation Assay (TGA) at 3 months in the anticoagulation +atorvastatin arm as compared to the anticoagulation arm." (NCT02331095)
Timeframe: 3 Months

,
InterventionnM*min (Median)
Enrollment3 Months
Anticoagulation11551275
Atorvastatin + Anticoagulation14401143

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The Reduction of Clinical Post-thrombotic Syndrome (PTS), as Objectively Evaluated With Villalta Scoring System

The Villata score for Post-Thrombotic Syndrome (PTS) stratifies the severity of post-thrombotic syndrome in lower extremity DVT. The score contains a combination of 5 subjective symptoms as reported by the patient (cramps, itching, pins and needles, heaviness, and pain) and 6 objective signs measured by a provider (edema, skin induration, hyperpigmentation, prominent veins on legs, redness, and tenderness on calf compression). Each sign is scaled from 0 (no or minimal) to 3 (severe) with a total score ranged from 0 to 33. Higher scores represent more severe disease. (NCT02331095)
Timeframe: 3 Months

,
Interventionscores on a scale (Median)
Enrollment3 Months
Anticoagulation76
Atorvastatin + Anticoagulation4.53.5

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The Rate of Major, Non-major, and All Hemorrhages Defined by the International Society on Thrombosis and Haemostasis (ISTH) Criteria

Major bleeding events were defined by the International Society on Thrombosis and Haemostasis (ISTH) criteria, with overt bleeding in critical organs (e.g. central nervous system, retroperitoneum), a >2 gram/dL drop in hemoglobin from baseline, or requiring at least two units of packed red blood cell transfusion meeting the criteria for major bleeding. Clinically relevant, non-major bleeding (CRNMB) events were defined as any other bleeding events reported by patients but not otherwise meeting the above listed criteria for major bleeding. (NCT02331095)
Timeframe: 3 months and 9 months

,
InterventionParticipants (Count of Participants)
3 Months9 Months
Anticoagulation00
Atorvastatin + Anticoagulation00

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The Rate of Arterial Thrombotic Events

Arterial thromboembolism was defined a new myocardial infarction (based on typical electrocardiographic findings and/or elevation of cardiac enzymes) or cerebral vascular accident (based on clinical syndrome of development of focal or global loss of brain function thought to be vascular in origin, confirmed by appropriate standard imaging studies). (NCT02331095)
Timeframe: 3 months and 9 months

,
InterventionParticipants (Count of Participants)
3 Months9 Months
Anticoagulation00
Atorvastatin + Anticoagulation00

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Change in Triglyceride Levels at 3 Months

(NCT02331095)
Timeframe: 3 Months

,
Interventionmg/dL (Mean)
Enrollment3 Months
Anticoagulation130.5127.4
Atorvastatin + Anticoagulation157.9135.3

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Change in the Levels of D-Dimer at 3 Months

(NCT02331095)
Timeframe: 3 Months

,
Interventionmcg/mL FEU (Median)
Enrollment3 Months
Anticoagulation2.120.36
Atorvastatin + Anticoagulation2.20.59

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Atherosclerotic Plaque (Measures of Total Atherosclerosis Plaque on Serial CCTA)

measures of total atherosclerosis plaque on serial CCTA (NCT02376010)
Timeframe: 1 year

Interventionmm cubed (Median)
Rivaroxaban20.1
Warfarin30.1

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Coronary Artery Calcium (Serial Calcium Scans)

serial calcium scans (NCT02376010)
Timeframe: 1 year

Interventionmm cubed (Median)
Rivaroxaban26.3
Warfarin40.5

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Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 days

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od614
Rivaroxaban Placebo Bid + Aspirin 100 mg od679

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Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 days

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od514
Rivaroxaban Placebo Bid + Aspirin 100 mg od588

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Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od584
Rivaroxaban Placebo Bid + Aspirin 100 mg od655

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Number of Mortality (All-cause)

(NCT02504216)
Timeframe: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 days

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od321
Rivaroxaban Placebo Bid + Aspirin 100 mg od297

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Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od140
Rivaroxaban Placebo Bid + Aspirin 100 mg od100

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Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered (NCT02504216)
Timeframe: For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od93
Rivaroxaban Placebo Bid + Aspirin 100 mg od73

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Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od62
Rivaroxaban Placebo Bid + Aspirin 100 mg od44

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Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od508
Rivaroxaban Placebo Bid + Aspirin 100 mg od584

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Number of Participants With Venous Thromboembolic (VTE) Events

Venous thromboembolic events were reported by investigator only. (NCT02504216)
Timeframe: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 days

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od25
Rivaroxaban Placebo Bid + Aspirin 100 mg od41

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Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 days

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od262
Rivaroxaban Placebo Bid + Aspirin 100 mg od356

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Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology

Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered. (NCT02504216)
Timeframe: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.

InterventionParticipants (Count of Participants)
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od433
Rivaroxaban Placebo Bid + Aspirin 100 mg od528

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Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4

Percentage of participants with time to first occurrence of composite efficacy endpoint 4 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, VTE-related deaths or major bleeding events up to Day 180) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo6.89
Rivaroxaban 10 mg5.71

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Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3

Percentage of participants with time to first occurrence of composite efficacy endpoint 3 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic non-fatal PE, incidental PE, VTE-related deaths, fatal/non-fatal ATE [MI, stroke {ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma} or any ATE] or fatal/non-fatal visceral VTE) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo10.7
Rivaroxaban 10 mg6.90

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Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2

Percentage of participants with time to first occurrence of composite efficacy endpoint 2 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE or VTE-related deaths) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo5.23
Rivaroxaban 10 mg3.81

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Percentage of Participants With All-Cause Mortality

Percentage of participants with all-cause mortality as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. Overall deaths occurred during observation period (defined by start to end date of the observation period [that is approximately 180 days] are reported here. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo23.8
Rivaroxaban 10 mg20.0

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Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE

Percentage of participants with time to the first occurrence of fatal or non-fatal visceral VTE as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo0.48
Rivaroxaban 10 mg0.24

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Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)

Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome. (NCT02555878)
Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

InterventionPercentage of participants (Number)
Placebo0.99
Rivaroxaban 10 mg1.98

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Percentage of Participants With Time to the First Occurrence of Minor Bleeding

Percentage of participants with time to the first occurrence of minor bleeding was reported. Minor bleeding (that is, minimal bleeding) is defined as overt bleeding episodes not meeting the criteria for major or clinically relevant non-major bleeding event. (NCT02555878)
Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

InterventionPercentage of participants (Number)
Placebo3.96
Rivaroxaban 10 mg6.91

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Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)

Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC). (NCT02555878)
Timeframe: Up to Day 180

,
InterventionPercentage of participants (Number)
Primary efficacy composite endpointSymptomatic lower extremity proximal DVTSymptomatic lower extremity distal DVTSymptomatic upper extremity DVTSymptomatic non-fatal PEAsymptomatic lower extremity proximal DVTIncidental PEVTE-related death
Placebo8.791.901.191.431.192.612.380.71
Rivaroxaban 10 mg5.952.140.480.951.190.951.430.24

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Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)

Percentage of participants with time to first occurrence of fatal/non-fatal ATE (a composite of occurrence of myocardial infarction (MI), stroke [ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma] or any other ATE recorded) event as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo1.66
Rivaroxaban 10 mg0.95

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Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1

Percentage of participants with time to first occurrence of composite efficacy endpoint 1 (composite of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE or all-cause mortality) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. (NCT02555878)
Timeframe: Up to Day 180

InterventionPercentage of participants (Number)
Placebo29.5
Rivaroxaban 10 mg23.1

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Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding

Percentage of participants with time to the first occurrence of clinically relevant non-major bleeding was reported. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life. (NCT02555878)
Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

InterventionPercentage of participants (Number)
Placebo1.98
Rivaroxaban 10 mg2.72

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Percentage of Participants With Time to the First Occurrence of Any Bleeding

Percentage of participants with time to the first occurrence of any bleeding event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding. (NCT02555878)
Timeframe: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

InterventionPercentage of participants (Number)
Placebo6.44
Rivaroxaban 10 mg11.1

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Number of Participants With Death or First Thromboembolic Event (DTE)

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism. (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)105
Antiplatelet78

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Number of Participants With Cardiovascular Death or Thromboembolic Event

Composite of CV-death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism (per adjudication). (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)83
Antiplatelet68

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Number of Participants With Composite Bleeding Endpoint of BARC (Bleeding Academic Research Consortium) 2, 3, or 5 Bleeds

Composite of BARC 2,3 or 5 bleedings (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)148
Antiplatelet85

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Number of Participants With Death or First Thromboembolic Event (DTE)

Death or first adjudicated thromboembolic event (DTE), defined as composite of all-cause death, any stroke, myocardial infarction (MI), symptomatic valve thrombosis, pulmonary embolism (PE), deep vein thrombosis (DVT), and non-central nervous system (CNS) systemic embolism. (NCT02556203)
Timeframe: Through study completion, on average 14 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)68
Antiplatelet63

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Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeds

ISTH major bleeds (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)49
Antiplatelet30

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Number of Participants With Net-clinical Benefit

The net-clinical-benefit defined as the adjudicated composite of all-cause death, any stroke, myocardial infarction, symptomatic valve thrombosis, pulmonary embolism, deep vein thrombosis, non-CNS systemic embolism (efficacy); VARC life-threatening, disabling and VARC major bleeds (safety). (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)137
Antiplatelet100

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Number of Participants With Primary Bleeding Event (PBE)

PBE is defined according to VARC (Valve Academic Research Consortium) definitions as the adjudicated composite of: Life-threatening, disabling or major bleeding. (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)46
Antiplatelet31

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Number of Participants With TIMI (Thrombolysis In Myocardial Infarction) Major / Minor Bleeds

Composite of TIMI major and minor bleedings (NCT02556203)
Timeframe: Through study completion, on average 16 months

InterventionParticipants (Count of Participants)
Rivaroxaban (Xarelto, BAY59-7939)42
Antiplatelet24

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Change From Baseline in Prothrombin Time at Day 3

Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. (NCT02564718)
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)

Interventionseconds (sec) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid3.74
Rivaroxaban (BAY59-7939) Suspension Tid1.13

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 8

Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. (NCT02564718)
Timeframe: 10 to 16 hours post-dose on Day 8 (bid dosing)

Interventionmicrogram per liter (mcg/L) (Geometric Mean)
Rivaroxaban (BAY59-7939) Suspension Bid2.5696
Rivaroxaban (BAY59-7939) Suspension TidNA

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1

Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. (NCT02564718)
Timeframe: 30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)

Interventionmicrogram per liter (mcg/L) (Geometric Mean)
30 minutes to 1.5 hours post-dose2 to 4 hours post-dose
Rivaroxaban (BAY59-7939) Suspension Bid85.200173.7641

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3

Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. (NCT02564718)
Timeframe: 2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing)

Interventionmicrogram per liter (mcg/L) (Geometric Mean)
2 to 8 hours post-dose
Rivaroxaban (BAY59-7939) Suspension Bid102.3285

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 3

Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. (NCT02564718)
Timeframe: 2 to 8 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 3 (tid dosing)

Interventionmicrogram per liter (mcg/L) (Geometric Mean)
30 minutes to 3 hours post-dose7 to 8 hours post-dose
Rivaroxaban (BAY59-7939) Suspension Tid32.28799.1716

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Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events

Central independent adjudication committee (CIAC) classified bleeding as follows: Major bleeding is defined as overt bleeding and •associated with a fall in hemoglobin of 2 gram/deciliter (g/dL) or more, •leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults, or •occurring in a critical site, example: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or •contributing to death. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding, but associated with: •medical intervention, or •unscheduled contact (visit or telephone call) with a physician, or •cessation (temporary) of study treatment, or •discomfort for the child such as pain (NCT02564718)
Timeframe: From start of study drug administration until 30-day post study treatment period

,
Interventioncount of participants (Number)
Major bleeding eventsClinically relevant non-major bleeding events
Rivaroxaban (BAY59-7939) Suspension Bid00
Rivaroxaban (BAY59-7939) Suspension Tid00

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Change From Baseline in Prothrombin Time at Day 1

Prothrombin time is a global clotting test used for the assessment of the extrinsic pathway of the blood coagulation cascade. (NCT02564718)
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)

Interventionseconds (sec) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid11.6
Rivaroxaban (BAY59-7939) Suspension Tid0.025

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Anti-factor Xa Activity (Anti-Xa) Values at Day 8

The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. (NCT02564718)
Timeframe: 10-16 hours post-dose on Day 8 (both bid and tid dosing)

Interventionmicrogram per liter (mcg/L) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid7.25
Rivaroxaban (BAY59-7939) Suspension Tid9.92

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Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 1

The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII. (NCT02564718)
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)

Interventionseconds (sec) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid13.6
Rivaroxaban (BAY59-7939) Suspension Tid2.33

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Change From Baseline in Activated Partial Thromboplastin Time (aPTT) at Day 3

The Activated partial thromboplastin time (aPTT) is a screening test for the intrinsic pathway and is sensitive for deficiencies of factors I, II, V, VIII, IX, X, XI and XII. (NCT02564718)
Timeframe: 10-16 hours post-dose on Day 8 (baseline), 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)

Interventionseconds (sec) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid7.02
Rivaroxaban (BAY59-7939) Suspension Tid3.47

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Concentration of Rivaroxaban in Plasma as a Measure of Pharmacokinetics at Day 1

Concentration of pharmacokinetic parameters of rivaroxaban in plasma was evaluated. (NCT02564718)
Timeframe: 30 minutes to 1.5 hours post-dose; 2 to 4 hours post-dose (bid dosing) and 30 minutes to 3 hours post-dose; 7 to 8 hours post-dose on Day 1 (tid dosing)

Interventionmicrogram per liter (mcg/L) (Geometric Mean)
30 minutes to 3 hours post-dose7 to 8 hours post-dose
Rivaroxaban (BAY59-7939) Suspension Tid42.683712.1027

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Number of Participants With Symptomatic Recurrent Venous Thromboembolism and Asymptomatic Deterioration in Thrombotic Burden on Repeat Imaging

Symptomatic recurrence of thromboembolism and asymptomatic deterioration was documented using the appropriate imaging test and confirmed by CIAC which was unaware of treatment assignment. Asymptomatic deterioration in thrombotic burden on repeat imaging, as assessed by the CIAC. Adjudication results were the basis for the final analyses. (NCT02564718)
Timeframe: From start of study drug administration until 30-day post study treatment period

,
Interventioncount of participants (Number)
Symptomatic recurrent venous thromboembolismAsymptomatic deterioration in thrombotic burden
Rivaroxaban (BAY59-7939) Suspension Bid00
Rivaroxaban (BAY59-7939) Suspension Tid00

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Anti-factor Xa Activity (Anti-Xa) Values at Day 1

The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. (NCT02564718)
Timeframe: 2-4 hours after the first dose on Day 1 (bid dosing) and 7-8 hours after the first dose on Day 1 (tid dosing)

Interventionmicrogram per liter (mcg/L) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid63.3
Rivaroxaban (BAY59-7939) Suspension Tid18.0

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Anti-factor Xa Activity (Anti-Xa) Values at Day 3

The individual anti-Factor Xa activity was determined ex-vivo using a photometric method. (NCT02564718)
Timeframe: 2-8 hours post-dose on Day 3 (bid dosing) and 0.5-3 hours post-dose on Day 3 (tid dosing)

Interventionmicrogram per liter (mcg/L) (Mean)
Rivaroxaban (BAY59-7939) Suspension Bid67.3
Rivaroxaban (BAY59-7939) Suspension Tid59.8

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Mean Duration of Hospitalization

Mean number of days of initial inpatient hospitalization (beginning from randomization to discharge from the hospital) plus any subsequent hospitalization(s) related to bleeding and/or venous thromboembolism (VTE) events up to 30 days were calculated. (NCT02584660)
Timeframe: Up to Day 30

InterventionDays (Mean)
Rivaroxaban0.191
Standard-of-care1.393

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Percentage of Participants Satisfied Using Site-of-Care Satisfaction Questionnaire

The Satisfaction to Site-of-Care Questionnaire (standard-of-care versus early discharge on rivaroxaban therapy) was administered after 7 days on anticoagulant therapy. Satisfaction to Site-of-Care (hospitalization versus home care) rates the participant's level of satisfaction to care and location with care received as well as preference to location of care provided. Participants rated the 3 items of this scale of 1=Very satisfied; 2=Quite satisfied; 3=Neither; 4=Quite dissatisfied; and 5=Very dissatisfied for satisfaction questions and for the 1 preference question responses included 1=In the hospital; 2=In the community; and 3=No preference. Higher score indicates more level of satisfaction. (NCT02584660)
Timeframe: Day 7

,
InterventionPercentage of participants (Number)
Satisfaction level: Very SatisfiedSatisfaction level: Quite SatisfiedSatisfaction level: NeitherSatisfaction level: Quite DissatisfiedSatisfaction level: Very DissatisfiedLocation of care: Very SatisfiedLocation of care: Quite SatisfiedLocation of care: NeitherLocation of care: Quite DissatisfiedLocation of care: Very DissatisfiedPreference of care: In the HospitalPreference of care: In the CommunityPreference of care: No Preference
Rivaroxaban60.433.34.22.1062.533.34.20018.85031.3
Standard-of-care62.723.76.85.11.759.330.56.81.71.747.540.711.9

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Treatment Satisfaction Assessment in Participants by Anti-clot Treatment Scale (ACTS)

ACTS is defined as a validated measure for assessing treatment satisfaction. The ACTS comprised of 2 subscales: Burdens (13 items: Item 1 to 13 [how much of limitation from taking part in vigorous physical activities, limitation from usual activities, bothered by bruising, bothered to avoid other medicines, limitation to diet, daily hassle, occasional hassle, difficult to follow treatment, time-consuming, worrying, frustrating, burden, negative impact on life respectively) and Benefits (4 items: Items 14 to 17 for evaluating confidence, reassurance, satisfaction, positive impact respectively) as a result of anti-clot treatment. The treatment experience scores ranged from 'Not at all' to 'Extremely' on a 5-point Likert scale (psychometric rating); higher scores indicate greater satisfaction with treatment. (NCT02584660)
Timeframe: Day 90

,
InterventionPercentage of participants (Number)
Item 1: Not at allItem 1: A littleItem 1: ModeratelyItem 1: Quite a bitItem 1: ExtremelyItem 2: Not at allItem 2: A littleItem 2: ModeratelyItem 2: Quite a bitItem 2: ExtremelyItem 3: Not at allItem 3: A littleItem 3: ModeratelyItem 3: Quite a bitItem 3: ExtremelyItem 4: Not at allItem 4: A littleItem 4: ModeratelyItem 4: Quite a bitItem 4: ExtremelyItem 5: Not at allItem 5: A littleItem 5: ModeratelyItem 5: Quite a bitItem 5: ExtremelyItem 6: Not at allItem 6: A littleItem 6: ModeratelyItem 6: Quite a bitItem 6: ExtremelyItem 7: Not at allItem 7: A littleItem 7: ModeratelyItem 7: Quite a bitItem 7: ExtremelyItem 8: Not at allItem 8: A littleItem 8: ModeratelyItem 8: Quite a bitItem 8: ExtremelyItem 9: Not at allItem 9: A littleItem 9: ModeratelyItem 9: Quite a bitItem 9: ExtremelyItem 10: Not at allItem 10: A littleItem 10: ModeratelyItem 10: Quite a bitItem 10: ExtremelyItem 11: Not at allItem 11: A littleItem 11: ModeratelyItem 11: Quite a bitItem 11: ExtremelyItem 12: Not at allItem 12: A littleItem 12: ModeratelyItem 12: Quite a bitItem 12: ExtremelyItem 13: Not at allItem 13: A littleItem 13: ModeratelyItem 13: Quite a bitItem 13: ExtremelyItem 14: Not at allItem 14: A littleItem 14: ModeratelyItem 14: Quite a bitItem 14: ExtremelyItem 15: Not at allItem 15: A littleItem 15: ModeratelyItem 15: Quite a bitItem 15: ExtremelyItem 16: Not at allItem 16: A littleItem 16: ModeratelyItem 16: Quite a bitItem 16: ExtremelyItem 17: Not at allItem 17: A littleItem 17: ModeratelyItem 17: Quite a bitItem 17: Extremely
Rivaroxaban51.1406.72.2077.813.36.72.2071.122.22.24.406033.34.42.208017.802.2075.6202.22.2073.322.24.40082.215.602.2084.415.600048.928.98.911.12.277.817.84.40084.415.600064.428.94.42.204.48.92026.7404.48.92035.631.18.92.215.633.3402.213.317.828.937.8
Standard-of-care61.821.810.91.83.670.9207.301.865.521.85.55.51.852.7209.110.97.36016.416.47.3056.425.55.512.7045.530.9201.81.878.212.77.31.8074.521.81.81.8043.616.418.210.910.96016.47.39.17.364.818.59.33.73.754.518.214.57.35.55.57.321.838.227.35.65.624.142.622.25.59.19.145.530.97.37.318.243.623.6

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Percentage of Participants With Number of Unplanned Hospital Visits or Physician Office for VTE Symptoms and/or Bleeding

Percentage of participants of unplanned hospitalization for VTE symptoms or bleeding-related hospital or physician visits were analyzed. (NCT02584660)
Timeframe: Up to 7, 14, 30 and 90 Days

,
InterventionPercentage of Participants (Number)
Up to 7 DaysUp to 14 DaysUp to 30 DaysUp to 90 Days
Rivaroxaban023.93.9
Standard-of-care001.66.3

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Mean Combined Duration of Initial and Subsequent Emergency Department (ED) Hospitalization for Any Reason

Mean combined duration of Initial and subsequent ED Stay and hospitalization for any reason within 30 and 90 days from randomization was analyzed. (NCT02584660)
Timeframe: Up to 30 and 90 Days

,
InterventionDays (Mean)
Within 30 DaysWithin 90 Days
Rivaroxaban0.6790.764
Standard-of-care1.5131.812

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Number of Participants With Heart Block

Heart block is a type of heart rhythm disorder (arrhythmia). It is the slowing down or interruption of the electrical signal from the upper chambers of the heart (the atria) to the lower chambers (the ventricles). The electrical signal causes the heart muscle to contract and the heart to beat. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC2
Aspirin3

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Number of Participants With Transient Ischemic Attack

Transient ischemic attack(TIA) - defined as a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. (NCT02666742)
Timeframe: First 30 days of post ablation

Interventionparticipants (Number)
DOAC6
Aspirin22

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Number of Participants With Stroke

Stroke - incidence of ischemic stroke - defined as an episode of neurological dysfunction caused by focal cerebral, spinal, or retinal infarction. (NCT02666742)
Timeframe: First 30 days of post ablation

InterventionParticipants (Count of Participants)
DOAC0
Aspirin8

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Number of Participants With Asymptomatic Cerebral Event on MRI - 24 Hours

MRI detected asymptomatic cerebrovascular events (ACE) at 24 hours. (NCT02666742)
Timeframe: 24 Hours post ablation

InterventionParticipants (Count of Participants)
DOAC15
Aspirin28

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Number of Participants With Groin Hematoma

A hematoma is a collection of blood outside of a blood vessel. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC3
Aspirin4

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Number of Participants With Fatal Pulmonary Embolism

A pulmonary embolism is a blood clot in the lung that occurs when a clot in another part of the body (often the leg or arm) moves through the bloodstream and becomes lodged in the blood vessels of the lung. This restricts blood flow to the lungs, lowers oxygen levels in the lungs and increases blood pressure in the pulmonary arteries. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC0
Aspirin1

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Number of Participants With Cardiac Tamponade

Cardiac tamponade is a medical emergency that takes place when abnormal amounts of fluid accumulate in the pericardial sac compressing the heart and leading to a decrease in cardiac output and shock. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC4
Aspirin3

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Number of Participants With In-hospital Mortality

Death occurring during the hospital stay. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC5
Aspirin3

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Number of Participants With Retroperitoneal Bleed

Retroperitoneal bleeding occurs when blood enters into space immediately behind the posterior reflection of the abdominal peritoneum. The organs of this space include the esophagus, aorta, inferior vena cava, kidneys, ureters, adrenals, rectum, parts of the duodenum, parts of the pancreas, and parts of the colon. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC2
Aspirin2

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Number of Participants With Progressive Heart Failure and Electromechanical Dissociation (EMD)

Heart failure means that the heart isn't pumping as well as it should be. (NCT02666742)
Timeframe: Day 30

InterventionParticipants (Count of Participants)
DOAC4
Aspirin4

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Number of Participants With Asymptomatic Cerebral Event on MRI - 30 Days

MRI detected asymptomatic cerebrovascular events (ACE) at 30 days follow-up. (NCT02666742)
Timeframe: 24 Hours to 30 days of post ablation

InterventionParticipants (Count of Participants)
DOAC8
Aspirin22

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Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 30 days Post-Procedure

Interventionpercent of participants (Number)
AtriClip With OAC5.0
AtriClip Without OAC5.1
Standard of Care With OAC0.0
Standard of Care Without OAC8.0
Combined Standard of Care7.8

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Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 days post index procedure

Interventionpercent of participants (Number)
AtriClip With OAC19.6
AtriClip Without OAC8.2
Standard of Care With OAC16.0
Standard of Care Without OAC6.5
Combined Standard of Care9.9

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Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days

Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. (NCT02701062)
Timeframe: 365 Days Post-Procedure

Interventionpercent of participants (Number)
AtriClip With OAC15.8
AtriClip Without OAC6.7
Combined AtriClip8.5
Standard of Care With OAC14.8
Standard of Care Without OAC7.5
Combined Standard of Care8.6

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Number of Perioperative Complications Associated With AtriClip Placement

Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. (NCT02701062)
Timeframe: Within any 24 hour period during the first 2 days post-index procedure

Interventionperioperative complications reported (Number)
AtriClip®0

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Number of Subjects With Intraoperative Successful Exclusion of LAA.

Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. (NCT02701062)
Timeframe: Intraoperative period

Interventionpercentage of participants (Number)
Total Patients, No Flow and No StumpTotal Patients, No Flow with Stump <= 5mmTotal Patients, No Flow with Stump <= 10mm
AtriClip®82.295.498.9

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Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)

To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form) (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)21.5
Randomized Arm 2 (LMWH)18.4
Preference Cohort 1 (DOACs)16.3
Preference Cohort 2 (LMWH)23.8

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Cumulative Rates of Major Bleeding

To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living). (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)5.2
Randomized Arm 2 (LMWH)5.6
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)7.6

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Cumulative Non-Fatal VTE Recurrence at 6 Months (%)

To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE. (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)6.1
Randomized Arm 2 (LMWH)8.8
Preference Cohort 1 (DOACs)7.5
Preference Cohort 2 (LMWH)4.1

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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.5
Randomized Arm 2 (LMWH)54.1
Preference Cohort 1 (DOACs)54.9
Preference Cohort 2 (LMWH)53.1

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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 3 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.7
Randomized Arm 2 (LMWH)53.3
Preference Cohort 1 (DOACs)55.8
Preference Cohort 2 (LMWH)54.9

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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 6-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.6
Randomized Arm 2 (LMWH)11.3
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)10.1

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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 3-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.2
Randomized Arm 2 (LMWH)10.7
Preference Cohort 1 (DOACs)10.3
Preference Cohort 2 (LMWH)10.5

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Number of Participants Who Discontinued Planned Drug Administration

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban4
Apixaban2

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Number of Participants With Clinically Relevant Non-major Bleeding

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban3
Apixaban0

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Number of Participants With Venous Thromboembolism (VTE)

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban0
Apixaban0

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Number of Patients That Held Drug for Menorrhagia

(NCT02829957)
Timeframe: 1, 2, and 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban0
Apixaban0

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PBAC Scores

"Measure Description: A PBAC Score of < 100 indicates a normal menstrual cycle. The lowest possible score would be zero. Higher values indicate worse outcomes. The higher theoretical range value cannot be calculated. The scoring mechanism is as follows;~Towels~1 point for each lightly stained towel~5 points or each moderately soiled towel~20 points if the towel is completely saturated with blood~Tampons~1 point for each lightly stained tampon~5 points for each moderately soiled tampon~10 points if the tampon is completely saturated with blood~Clots~1 point for small clots~5 points for large clots" (NCT02829957)
Timeframe: 3 months

Interventionscore on a scale (Median)
Rivaroxaban292
Apixaban146

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Physical Component Summary of Standard From 36

The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. (NCT02829957)
Timeframe: 3 months

InterventionScore (Median)
Rivaroxaban55.5
Apixaban45.6

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Number of Participants Who Crossed Over to Another Anticoagulant

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban3
Apixaban1

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Number of Participants With Major Hemorrhage

(NCT02829957)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
Rivaroxaban0
Apixaban0

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Hemoglobin Concentration

Measure Description: Normal hemoglobin range for adult women - 12 - 16 g/dL. Lower levels indicate worse outcomes. (NCT02829957)
Timeframe: 3 months

Interventiong/dl (Median)
Rivaroxaban12.8
Apixaban13.25

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The Rate of Prosthetic Leaflets With > 50% Motion Reduction as Assessed by Cardiac 4DCT-scan

The rate of prosthetic leaflets with RLM> grade 3 as assessed by cardiac 4DCT (NCT02833948)
Timeframe: 3 months

Interventionleaflets (Number)
ASA + Clopidogrel14
Rivaroxaban + ASA3

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The Rate of Prosthetic Leaflets With Thickening as Assessed by Cardiac 4DCT-scan

The rate of prosthetic leaflet with HALT as assessed by cardiac 4DCT-scan (NCT02833948)
Timeframe: 3 months

InterventionLeaflets (Number)
ASA + Clopidogrel53
Rivaroxaban + ASA16

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Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM) - as Exploratory Analysis.

Thromboembolic event, Dichotomization by RLM (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
RLM>2 (-)2
RLM(+)0

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Aortic Transvalvular Mean Pressure Gradient (mmHg) as Determined by Transthoracic Echocardiography.

"Transprosthetic mean pressure gradiënt as determined by transthoracic echocardiography at three months after randomization.~scale [0-100]" (NCT02833948)
Timeframe: 3 months

Interventionmm Hg (Mean)
ASA + Clopidogrel10
Rivaroxaban + ASA10

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Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT) - as Exploratory Analysis.

Death, Dichotomization by HALT (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
HALT (-)0
HALT (+)0

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Death Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (RLM)- as Exploratory Analysis.

Death, Dichotomization by RLM (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
RLM>2 (-)0
RLM(+)0

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Effective Orifice Area (cm^2) as Determined by Transthoracic Echocardiography.

"Effective orifice area (cm2) as determined by transthoracic echocardiography at three months after randomization.~scale [0.1-4.0]" (NCT02833948)
Timeframe: 3 months

Interventioncm2 (Mean)
ASA + Clopidogrel1.8
Rivaroxaban + ASA1.8

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Thromboembolic Event Assessed in the Main GALILEO Study and Analyzed in the GALILEO-4D Substudy With Regards to Occurence of the Leaflet Abnormalities (HALT)- as Exploratory Analysis.

Thromboembolic event, Dichotomization by HALT (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
HALT (-)2
HALT (+)0

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Rate of Patients With at Least One Prosthetic Leaflet With >50% Motion Reduction as Assessed by Cardiac 4DCT-scan

Reduced systolic leaflet excursion is classified as: (I) normal, (II) mildly reduced (<50%), (III) moderate to severely reduced (>50%), and (IV) immobile. Reduced systolic leaflet excursion is considered significant when it is > 50% or immobile. Quantitative assessment of leaflet motion is performed with a blood pool inversion volume rendered cine reconstruction throughout the cardiac cycle evaluating the bioprosthetic leaflets. (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
ASA + Clopidogrel11
Rivaroxaban + ASA2

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The Rate of Patients With at Least One Prosthetic Leaflet With Thickening as Assessed by Cardiac 4DCT-scan

The rate of patients with at least one prosthetic leaflet with hypoattenuated leaflet thickening (HALT) as assessed by cardiac 4DCT. (NCT02833948)
Timeframe: 3 months

InterventionParticipants (Count of Participants)
ASA + Clopidogrel33
Rivaroxaban + ASA12

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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

TEAEs were defined as those adverse events (AEs) that occurred from the first day of study drug to the last day of study drug + 2 days inclusive. An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product.AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. (NCT02846532)
Timeframe: Up to 12 months

Interventionpercentage of participants (Number)
Rivaroxaban (Part A)91.7
Rivaroxaban (Part B)85.9
Aspirin (Part B)85.3

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Plasma Concentration of Rivaroxaban at Day 1 (0.5-1.5 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 0.5-1.5 hours postdose

Interventionmicrograms per liter (mcg/L) (Mean)
Rivaroxaban (Part A)46.69
Rivaroxaban (Part B)92.86

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Plasma Concentration of Rivaroxaban at Day 1 (1.5-4 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 1.5-4 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)86.62
Rivaroxaban (Part B)103.61

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Plasma Concentration of Rivaroxaban at Day 4 (0.5-1.5 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 0.5-1.5 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)107.58

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Plasma Concentration of Rivaroxaban at Day 4 (1.5-4 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 1.5-4 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)147.18

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Plasma Concentration of Rivaroxaban at Day 4 (6-8 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 6-8 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)66.81

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Plasma Concentration of Rivaroxaban at Day 4 (Up to 3 Hours Predose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: Up to 3 hours predose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)36.58

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Plasma Concentration of Rivaroxaban at Month 3 (Up to 3 Hours Predose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: Up to 3 hours predose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)38.23
Rivaroxaban (Part B)29.41

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aPTT at Day 4 (Up to 3 Hours Predose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: Up to 3 hours predose

Interventionseconds (Mean)
Rivaroxaban (Part A)33.08

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Absolute PT at Day 4 (0.5-1.5 Hours Postdose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 0.5-1.5 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)17.95

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Percentage of Participants With Bleeding Events

Bleeding events were categorized into major, clinically relevant non-major bleeding (CRNM), and trivial bleeding events. Major bleeding: overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more; or leading to a transfusion of the equivalent of 2 or more units of packed red blood cells or whole blood in adults; or occurring in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal; or contributing to death. CRNM bleeding: overt bleeding not meeting the criteria for major bleeding but associated with: Medical intervention, or Unscheduled contact with a physician, cessation of study treatment, or Discomfort for the subject such as pain, or Impairment of activities of daily life. Trivial bleeding: any other overt bleeding event that does not meet criteria for CRNM bleeding. (NCT02846532)
Timeframe: Up to 12 months

,,
Interventionpercentage of participants (Number)
Any bleeding eventMajor BleedingClinically relevant non-major bleedingTrivial bleeding
Aspirin (Part B)41.208.835.3
Rivaroxaban (Part A)33.308.325.0
Rivaroxaban (Part B)35.91.66.332.8

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Percentage of Participants With Any Thrombotic Event (Venous or Arterial and Symptomatic or Asymptomatic)

Thrombotic event was defined as the appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or the occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism). The event included ischemic stroke, pulmonary embolism, venous thrombosis, arterial/intracardiac thrombosis, and other thrombosis. (NCT02846532)
Timeframe: Up to 12 months

,,
Interventionpercentage of participants (Number)
Any thrombotic eventIschemic strokePulmonary embolismVenous thrombosisArterial/intracardiac thrombosisOther thrombosis
Aspirin (Part B)8.82.905.900
Rivaroxaban (Part A)8.3008.300
Rivaroxaban (Part B)1.601.6000

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aPTT at Month 3 (0.5-1.5 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 0.5-1.5 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)26.60
Rivaroxaban (Part B)31.15

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aPTT at Month 3 (2.5-4 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 2.5-4 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)26.74
Rivaroxaban (Part B)31.67

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Plasma Concentration of Rivaroxaban at Month 3 (0.5-1.5 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 0.5-1.5 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)86.25
Rivaroxaban (Part B)94.12

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Plasma Concentration of Rivaroxaban at Month 3 (2.5-4 Hours Postdose)

Plasma rivaroxaban concentrations for Parts A and B were assessed. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 2.5-4 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)96.67
Rivaroxaban (Part B)102.99

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Absolute PT at Day 1 (1.5-4 Hours Postdose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 1.5-4 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)16.58
Rivaroxaban (Part B)18.76

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Absolute PT at Day 4 (1.5-4 Hours Postdose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 1.5-4 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)18.73

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Absolute PT at Day 4 (6-8 Hours Postdose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 6-8 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)16.13

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Absolute PT at Day 4 (Up to 3 Hours Predose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: Up to 3 hours predose

Interventionseconds (Mean)
Rivaroxaban (Part A)15.21

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Absolute PT at Month 3 (0.5-1.5 Hours Postdose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 0.5-1.5 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)20.13
Rivaroxaban (Part B)18.89

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Absolute PT at Month 3 (2.5-4 Hours Postdose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 2.5-4 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)19.14
Rivaroxaban (Part B)19.69

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Absolute PT at Month 3 (Up to 3 Hours Predose)

Absolute PT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: Up to 3 hours predose

Interventionseconds (Mean)
Rivaroxaban (Part A)17.59
Rivaroxaban (Part B)16.45

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Activated Partial Thromboplastin Time (aPTT) at Day 1 (0.5-1.5 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 0.5-1.5 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)31.4
Rivaroxaban (Part B)30.69

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Absolute Prothrombin Time (PT) at Day 1 (0.5-1.5 Hours Postdose)

Absolute prothrombin time was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 0.5-1.5 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)15.46
Rivaroxaban (Part B)18.02

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Anti-FXa at Day 1 (0.5-1.5 Hours Postdose)

Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 0.5-1.5 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)66.93
Rivaroxaban (Part B)99.46

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Anti-FXa at Day 1 (1.5-4 Hours Postdose)

Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 1.5-4 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)74.06
Rivaroxaban (Part B)104.57

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Anti-FXa at Day 4 (6-8 Hours Postdose)

Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 6-8 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)74.21

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Anti-FXa at Month 3 (0.5-1.5 Hours Postdose)

Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 0.5-1.5 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part B)110.90

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Anti-FXa at Month 3 (2.5-4 Hours Postdose)

Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: 2.5-4 hours postdose

Interventionmcg/L (Mean)
Rivaroxaban (Part B)93.48

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Anti-FXa at Month 3 (Up to 3 Hours Predose)

Anti-FXa was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: Up to 3 hours predose

Interventionmcg/L (Mean)
Rivaroxaban (Part A)60.51
Rivaroxaban (Part B)53.41

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aPTT at Month 3 (Up to 3 Hours Predose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Month 3: Up to 3 hours predose

Interventionseconds (Mean)
Rivaroxaban (Part A)25.36
Rivaroxaban (Part B)28.70

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aPTT at Day 1 (1.5-4 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 1: 1.5-4 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)32.83
Rivaroxaban (Part B)30.25

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aPTT at Day 4 (0.5-1.5 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 0.5-1.5 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)36.17

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aPTT at Day 4 (1.5-4 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average for the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 1.5-4 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)37.58

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aPTT at Day 4 (6-8 Hours Postdose)

aPTT was assessed as pharmacodynamic parameter. Each participant was assessed once within the specified time-range and the average of the participants included in the given time-range is presented here. (NCT02846532)
Timeframe: Day 4: 6-8 hours postdose

Interventionseconds (Mean)
Rivaroxaban (Part A)32.83

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Hemorrhagic Stroke

"The event rate of Hemorrhagic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.03
Rivaroxaban (Dabigatran vs Rivaroxaban)0.16
Dabigatran (Dabigatran vs Apixaban)0.07
Apixaban (Dabigatran vs Apixaban)NA

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Lower GI Bleeding

"The event rate of Lower GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.08
Rivaroxaban (Dabigatran vs Rivaroxaban)1.17
Dabigatran (Dabigatran vs Apixaban)0.98
Apixaban (Dabigatran vs Apixaban)0.58

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Major Urogenital Bleeding

"The event rate of major urogenital bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)NA
Rivaroxaban (Dabigatran vs Rivaroxaban)0.01
Dabigatran (Dabigatran vs Apixaban)NA
Apixaban (Dabigatran vs Apixaban)NA

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Major Other Bleeding

"The event rate of major other bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.13
Rivaroxaban (Dabigatran vs Rivaroxaban)0.18
Dabigatran (Dabigatran vs Apixaban)0.11
Apixaban (Dabigatran vs Apixaban)0.13

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Major Intracranial Bleeding

"The event rate of major intracranial bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.27
Rivaroxaban (Dabigatran vs Rivaroxaban)0.41
Dabigatran (Dabigatran vs Apixaban)0.24
Apixaban (Dabigatran vs Apixaban)0.21

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Stroke Overall (Hemorrhagic, Ischemic, Uncertain)

"The event rate of overall stroke (hemorrhagic, ischemic, uncertain) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Length of Follow-up: The post-index follow-up period began the day following the NOAC index date and ended on whichever of the following occurred earliest:~The day of discontinuation of the index NOAC exposure;~The day before a switch to an anticoagulant different from the index exposure;~The day before a change in dose for the index NOAC;~The end of continuous eligibility of a patient in the health plan (disenrollment);~The end of the study observation period; or~The date of death of the patient." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.52
Rivaroxaban (Dabigatran vs Rivaroxaban)0.69
Dabigatran (Dabigatran vs Apixaban)0.46
Apixaban (Dabigatran vs Apixaban)0.36

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Major Extracranial Bleeding

"The event rate of major extracranial bleeding (Major GI bleeding, Major urogenital bleeding and Major other bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.55
Rivaroxaban (Dabigatran vs Rivaroxaban)1.83
Dabigatran (Dabigatran vs Apixaban)1.44
Apixaban (Dabigatran vs Apixaban)1.03

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Ischemic Stroke

"The event rate of ischemic stroke in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.5
Rivaroxaban (Dabigatran vs Rivaroxaban)0.54
Dabigatran (Dabigatran vs Apixaban)0.39
Apixaban (Dabigatran vs Apixaban)0.36

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Upper GI Bleeding

"The event rate of Upper GI Bleeding in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.41
Rivaroxaban (Dabigatran vs Rivaroxaban)0.55
Dabigatran (Dabigatran vs Apixaban)0.37
Apixaban (Dabigatran vs Apixaban)0.34

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All-cause Mortality

"The event rate of all-cause mortality in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.54
Rivaroxaban (Dabigatran vs Rivaroxaban)1.37
Dabigatran (Dabigatran vs Apixaban)1.46
Apixaban (Dabigatran vs Apixaban)1.25

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TIA

"The event rate of transient ischemic attack (TIA) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)0.26
Rivaroxaban (Dabigatran vs Rivaroxaban)0.20
Dabigatran (Dabigatran vs Apixaban)0.28
Apixaban (Dabigatran vs Apixaban)0.17

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Overall Major Bleeding

"The event rate of overall Major bleeding (Hemorrhagic Stroke, Major Intracranial Bleeding and Major Extracranial Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first." (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.82
Rivaroxaban (Dabigatran vs Rivaroxaban)2.24
Dabigatran (Dabigatran vs Apixaban)1.69
Apixaban (Dabigatran vs Apixaban)1.24

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Major GI Bleeding

"The event rate of major GI bleeding (Upper GI Bleeding and Lower GI Bleeding) in patients matched on propensity scores without index year.~Event rates were calculated as the total number of patients in each treatment group who had the outcome during follow-up divided by the total person-years at risk in the cohort.~Follow-up time was the time elapsed from the index date to the date of the outcome of interest, disenrollment, end of the observation period (available data), death, discontinuation of the NOAC, or switch to a different NOAC, whichever came first" (NCT03026556)
Timeframe: Baseline (July 1, 2010) until end of the observation period (June 30, 2016), 6 Years

InterventionEvent Rate in 100 person-years (Number)
Dabigatran (Dabigatran vs Rivaroxaban)1.45
Rivaroxaban (Dabigatran vs Rivaroxaban)1.66
Dabigatran (Dabigatran vs Apixaban)1.36
Apixaban (Dabigatran vs Apixaban)0.92

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Number of Subjects Experiencing Clinically Relevant Non-major Bleeding

Clinically relevant non-major bleeding (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

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Number of Subjects Experiencing Major Bleeding

Major bleeding (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

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Number of Subjects Experiencing Vascular Events (Myocardial Infarction, Ischemic Stroke)

MI, ischemic stroke, peripheral arterial embolism (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin1
Apixaban0
Rivaroxaban0

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Number of Subjects With Clinically Relevant Bleeding Events

Primary outcome of Clinically relevant bleeding (composite of major bleeding (MB) and/or clinically relevant non major bleeding (CRNMB)) (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

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Number of Subjects With Premature Termination of Study Medication

Premature termination of study medication (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

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Number of Subjects With Recurrent Venous Thromboembolism (VTE)

Primary efficacy outcome of recurrent VTE (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban1
Rivaroxaban0

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Number of Subjects Experiencing All-cause Mortality

All cause mortality (NCT03196349)
Timeframe: Randomization to 12 months

InterventionParticipants (Count of Participants)
Warfarin0
Apixaban0
Rivaroxaban0

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The Number of Patients With Cardiac Tamponade and Pericardiocentesis.

The number of patients with cardiac tamponade and pericardiocentesis. Cardiac tamponade diagnosis (ICD 10 code 4200001) on the same or next day as catheter ablation or percutaneous coronary intervention (PCI), Pericardiocentesis (Medical Data Vision (MDV) procedure code 140010510) on the same or next day as catheter ablation or PCI. (NCT03254147)
Timeframe: One year

InterventionNumber of Patients (Number)
Patients Prescribed With Non-warfarin Oral Anti Coagulants1

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The Number of Patients With Emergency Surgery and Major Bleeding Due to Fracture or Trauma.

The number of patients with emergency surgery and major bleeding due to fracture or trauma. Where emergency surgery defined as any surgical procedure (International Classification of Diseases (ICD) 10 code K000-879) performed on the same day as hospital admission with additional claims, major bleeding due to fracture is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any fracture, and major bleeding due to trauma is any bleeding associated with hospitalization or blood transfusion (ICD10 code E83.111) accompanied by any trauma. (NCT03254147)
Timeframe: One year

InterventionNumber of Patients (Number)
Age <=64Age 65-74Age >=75
Patients Prescribed With Non-warfarin Oral Anti Coagulants143584

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Percent Change in Anti-Fxa Activity From Baseline to the End of Bolus (EOB) Nadir.

The percent change from baseline in anti-FXa activity at its end of bolus (EOB) nadir. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-94.50
Cohort 1 Apixaban 5 mg BID/Placebo-14.00
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-97.50
Cohort 2 Rivaroxaban 15 mg BID/Placebo-18.00
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-65.50
Cohort 3 Edooxaban 60 mg QD/Placebo-16.00
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-22.50
Cohort 4 Edooxaban 60 mg QD/Placebo-15.00
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-94.00
Cohort 5 Apixaban 5 mg BID/Placebo-10.00
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-96.00
Cohort 6 Apixaban 10 mg BID/Placebo-18.00
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-58.00
Cohort 7 Edoxaban 30 mg QD/Placebo-8.00
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-94.50
Cohort 8 Apixaban 10 mg BID/Placebo-5.00
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-95.00
Cohort 9 Rivaroxaban 15 mg BID/Placebo-11.00
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-73.00
Cohort 10 Edoxaban 60 mg QD/Placebo-4.00

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Change in Thrombin Generation From Baseline to the End of Infusion (EOI) Nadir.

The change in thrombin generation from baseline to its EOI peak. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours

InterventionnM.min (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet1000.630
Cohort 1 Apixaban 5 mg BID/Placebo171.220
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet1329.580
Cohort 2 Rivaroxaban 15 mg BID/Placebo207.590
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet804.405
Cohort 3 Edooxaban 60 mg QD/Placebo347.535
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet910.935
Cohort 4 Edooxaban 60 mg QD/Placebo236.610
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet1130.575
Cohort 5 Apixaban 5 mg BID/Placebo118.130
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet1119.41
Cohort 6 Apixaban 10 mg BID/Placebo108.67
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet833.46
Cohort 7 Edoxaban 30 mg QD/Placebo175.72
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet1058.09
Cohort 8 Apixaban 10 mg BID/Placebo138.14
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet1173.38
Cohort 9 Rivaroxaban 15 mg BID/Placebo293.15
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet793.44
Cohort 10 Edoxaban 60 mg QD/Placebo-72.69

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Change in Thrombin Generation From Baseline to the End of Bolus (EOB) Nadir.

The change in thrombin generation from baseline to its EOB peak. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours

InterventionnM.min (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet1145.03
Cohort 1 Apixaban 5 mg BID/Placebo179.94
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet1337.28
Cohort 2 Rivaroxaban 15 mg BID/Placebo209.99
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet758.92
Cohort 3 Edooxaban 60 mg QD/Placebo215.71
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet815.07
Cohort 4 Edooxaban 60 mg QD/Placebo48.59
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet1244.30
Cohort 5 Apixaban 5 mg BID/Placebo103.13
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet1177.47
Cohort 6 Apixaban 10 mg BID/Placebo0.16
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet781.42
Cohort 7 Edoxaban 30 mg QD/Placebo67.97
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet1184.62
Cohort 8 Apixaban 10 mg BID/Placebo2.69
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet1306.23
Cohort 9 Rivaroxaban 15 mg BID/Placebo117.50
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet902.17
Cohort 10 Edoxaban 60 mg QD/Placebo-92.82

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Percent Change in Anti-Fxa Activity From Baseline to the End of Infusion (EOI) Nadir.

The primary efficacy endpoint is the percent change in the anti-FXa activity from baseline to the end of infusion (EOI) nadir. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-94.50
Cohort 1 Apixaban 5 mg BID/Placebo-29.00
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-98.00
Cohort 2 Rivaroxaban 15 mg BID/Placebo-37.00
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-81.00
Cohort 3 Edooxaban 60 mg QD/Placebo-47.50
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-75.50
Cohort 4 Edooxaban 60 mg QD/Placebo-37.00
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-93.00
Cohort 5 Apixaban 5 mg BID/Placebo-34.00
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-97.00
Cohort 6 Apixaban 10 mg BID/Placebo-31.00
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-52.50
Cohort 7 Edoxaban 30 mg QD/Placebo-37.00
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-92.00
Cohort 8 Apixaban 10 mg BID/Placebo-24.00
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-93.50
Cohort 9 Rivaroxaban 15 mg BID/Placebo-37.00
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-63.50
Cohort 10 Edoxaban 60 mg QD/Placebo-27.00

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Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Bolus (EOB) Nadir.

The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOB nadir. (NCT03310021)
Timeframe: Baseline to the end of bolus (EOB) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-93.00
Cohort 1 Apixaban 5 mg BID/Placebo-11.94
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-97.72
Cohort 2 Rivaroxaban 15 mg BID/Placebo-28.57
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-78.20
Cohort 3 Edooxaban 60 mg QD/Placebo-17.60
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-56.05
Cohort 4 Edooxaban 60 mg QD/Placebo-2.49
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-94.45
Cohort 5 Apixaban 5 mg BID/Placebo5.80
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-93.57
Cohort 6 Apixaban 10 mg BID/Placebo-12.94
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-70.88
Cohort 7 Edoxaban 30 mg QD/Placebo-5.48
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-91.61
Cohort 8 Apixaban 10 mg BID/Placebo-0.32
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-95.51
Cohort 9 Rivaroxaban 15 mg BID/Placebo-14.02
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-75.80
Cohort 10 Edoxaban 60 mg QD/Placebo-17.91

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Percent Change in Free Fxa Inhibitor Concentration From Baseline to the End of Infusion (EOI) Nadir.

The percent change from baseline in free FXa inhibitors concentration (ng/mL) at its EOI nadir. (NCT03310021)
Timeframe: Baseline to the end of infusion (EOI) nadir, approximately 2.5 hours

Interventionpercent change (Median)
Cohort 1 Apixaban 5 mg BID/Low Dose Andexanet-92.940
Cohort 1 Apixaban 5 mg BID/Placebo-33.550
Cohort 2 Rivaroxaban15 mg BID/High Dose Andexanet-98.650
Cohort 2 Rivaroxaban 15 mg BID/Placebo-39.390
Cohort 3 Edoxaban 60 mg QD/High Dose Andexanet-85.005
Cohort 3 Edooxaban 60 mg QD/Placebo-48.710
Cohort 4 Edoxaban 60 mg QD/High Dose Andexanet-81.040
Cohort 4 Edooxaban 60 mg QD/Placebo-42.755
Cohort 5 Apixaban 5 mg BID/Low Dose Andexanet-93.495
Cohort 5 Apixaban 5 mg BID/Placebo-31.830
Cohort 6 Apixaban 10 mg BID/High Dose Andexanet-96.65
Cohort 6 Apixaban 10 mg BID/Placebo-29.02
Cohort 7 Edoxaban 30 mg QD/Low Dose Andexanet-62.72
Cohort 7 Edoxaban 30 mg QD/Placebo-24.34
Cohort 8 Apixaban 10 mg BID/Low Dose Andexanet-90.63
Cohort 8 Apixaban 10 mg BID/Placebo-31.45
Cohort 9 Rivaroxaban 15 mg BID/Low Dose Andexanet-94.89
Cohort 9 Rivaroxaban 15 mg BID/Placebo-37.82
Cohort 10 Edoxaban 60 mg QD /Low Dose Andexanet-67.10
Cohort 10 Edoxaban 60 mg QD/Placebo-34.25

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Total Blood Loss After Operation

Total blood loss was calculated according to Nadler et al., which used maximum postoperative reduction of the Hb level adjust for weight and height of the patient. The formula is as follows, Total blood loss = (Total blood volume x [change in Hb level / preoperative Hb level])x1000+volume transfused (NCT03328832)
Timeframe: From the operation to the postoperative day 3 or 4

Interventionml (Mean)
Combined Topical TXA and Floseal678
Topical TXA Alone733

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Blood Transfusion Rate

We will record the event of blood transfusion, and calculate the incidence of transfusion (NCT03328832)
Timeframe: From the operation to the postoperative day 3 or 4

InterventionParticipants (Count of Participants)
Combined Topical TXA and Floseal1
Topical TXA Alone0

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Incidence of Thrombosis Events

The composite of any venous thromoembolism events, ischemic heart attacks, cerebrovascular accidents (NCT03328832)
Timeframe: within 30 days of the operation

InterventionParticipants (Count of Participants)
Combined Topical TXA and Floseal0
Topical TXA Alone0

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Number of Participants With Postthrombotic Syndrome as Determined by Villalta Score

Detection of the postthrombotic syndrome (PTS) was made according to the Villalta score (a combination of 5 subjective symptoms and 6 objective signs of chronic venous disease) ranged from 0 (no signs) to 33 scores (maximal severity). PTS defined as 5 and more scores; mild PTS as 5-9 scores; moderate PTS as 10-14 scores; severe PTS as 15 and more scores. (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings3
Control: Rivaroxaban + Stockings Only22

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Number of Participants With Full Recanalization of the Popliteal Vein

Full recanalization of popliteal vein suggests the residual venous obstruction (RVO) less than 20%. The RVO was assessed by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without any compression multiplied by 100%. (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings42
Control: Rivaroxaban + Stockings Only28

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Minor Bleeding

any non-major or non-clinically relevant bleeding does not require the suspension of therapy and changes in the patient's lifestyle (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings2
Control: Rivaroxaban + Stockings Only2

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Major Bleeding

according to the International Society of Thrombosis and Hemostasis (ISTH) definition, major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or bleeding causing a fall in hemoglobin level of 20 g/L or 1.24 mmol/L or more, or leading to transfusion of two or more units of whole blood or red cells (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings0
Control: Rivaroxaban + Stockings Only0

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Extension of Residual Venous Obstruction by Marder Score

Residual venous obstruction (RVO) defined as a thrombotic masses occupying 20% and more of the vein cross-sectional diameter was measured by duplex ultrasound and calculated as the vein cross-sectional diameter under the maximal compression divided on the diameter without compression and multiplied by 100%. The extension of RVO was assessed by Marder score, the sum of all affected venous segments, evaluated by different scores (see Appendix of the Protocol), that ranged from 0 (no RVO) to 34 (RVO in all possible venous segments in one limb). (NCT03413618)
Timeframe: 12 months

InterventionMarder score (Mean)
Experimental: Rivaroxaban + Diosmin + Stockings0.3
Control: Rivaroxaban + Stockings Only1.9

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Clinically Relevant Non-major Bleeding

any non-major bleeding requiring anticoagulant withdrawal, and/or performing haemostatic measures, and/or hospitalization, and/or an unscheduled medical appointment (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings1
Control: Rivaroxaban + Stockings Only2

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Adverse Events

any adverse events detected or suspected (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings5
Control: Rivaroxaban + Stockings Only4

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The Value of Venous Clinical Severity Score

Venous Clinical Severity Score (VCSS) is a combination of subjective symptoms and objective signs of CVD aimed to assess the severity of disease and ranges from 0 (no signs and symptoms of CVD) to 30 (severe signs and symptoms of CVD) (NCT03413618)
Timeframe: 12 months

InterventionVCSS score (Mean)
Experimental: Rivaroxaban + Diosmin + Stockings1.2
Control: Rivaroxaban + Stockings Only4.4

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The Value of Chronic Lower Limb Venous Insufficiency Questionnaire - 20 Items

Chronic Lower Limb Venous Insufficiency Questionnaire - 20 items (CIVIQ-20) is a venous specific questionnaire to assess the disease-specific quality of life (QoL). It contains 20 items of 1-5 scores, totally, from 20 (best QoL) to100 (worst QoL) scores. (NCT03413618)
Timeframe: 12 months

InterventionCIVIQ-20 scores (Mean)
Experimental: Rivaroxaban + Diosmin + Stockings22.1
Control: Rivaroxaban + Stockings Only28.8

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Number of Participants With Symptomatic Pulmonary Embolism

detection of symptomatic pulmonary embolism verified with CT pulmonary angiogram (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings0
Control: Rivaroxaban + Stockings Only0

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Number of Participants With Recurrent Symptomatic or Asymptomatic DVT

detection of any episode of recurrent DVT with or without clinical signs verified by duplex ultrasound (NCT03413618)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Experimental: Rivaroxaban + Diosmin + Stockings1
Control: Rivaroxaban + Stockings Only6

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Time in Therapeutic Range (TTR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

TTR was defined as the duration of time in which the participant's INR values were within a desired range (2 to 3). INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventiondays (Median)
Acenocoumarol: Naive60.2
Acenocoumarol: Non-Naive59.6
Warfarin: Naive66.2
Warfarin: Non-Naive58.9

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Risk of Thromboembolic Events: CHADS2 Score

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHADS2 score. CHADS2 score was assessed by combining score of 5 risk factors (congestive heart failure history, hypertension history, age >=75 years, diabetes mellitus history and stroke/transient ischemic attack symptoms previously). Total CHADS2 score ranged from 0-6 where 0 =low risk and 6 =high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionstroke risk per year (Mean)
Apixaban: Naive1.7
Apixaban: Non Naive2.8
Acenocoumarol: Naive1.9
Acenocoumarol: Non-Naive2.3
Warfarin: Naive1.8
Warfarin: Non-Naive2.5
Dabigatran: Naive1.5
Dabigatran: Non-Naive2.6
Rivaroxaban: Naive1.5
Rivaroxaban: Non-Naive2.6

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Risk of Thromboembolic Events: CHA2DS2Vasc Score

Thromboembolic events were defined as an embolic stroke that occurred when a blood clot that formed elsewhere in the body breaks loose and travels to the brain via bloodstream. Risk of thromboembolic events was calculated using CHA2DS2Vasc score. CHA2DS2Vasc score was assessed by combining score of 8 risk factors (female, >=65 and <75 years, congestive heart failure history, hypertension history, diabetes mellitus history, vascular disease history, age >=75 years and stroke/TIA symptoms previously). Total CHA2DS2Vasc score ranged from 0-9 where 0=low risk and 9=high risk of stroke. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionstroke risk per year (Mean)
Apixaban: Naive3.0
Apixaban: Non Naive4.4
Acenocoumarol: Naive3.2
Acenocoumarol: Non-Naive3.7
Warfarin: Naive2.9
Warfarin: Non-Naive3.9
Dabigatran: Naive2.7
Dabigatran: Non-Naive4.0
Rivaroxaban: Naive2.7
Rivaroxaban: Non-Naive4.1

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Number of Participants With Apixaban Adherence With VKA, Dabigatran and Rivaroxaban as Assessed by Discontinuation Throughout the Year

Discontinuation rate was defined as the lack of subsequent prescription of the index drugs within 2 months after last supply day of the last prescription. It was analyzed by calculating the treatment withdrawal or switch rate. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive881
Apixaban: Non Naive236
Acenocoumarol: Naive11326
Acenocoumarol: Non-Naive85
Warfarin: Naive1009
Warfarin: Non-Naive127
Dabigatran: Naive1002
Dabigatran: Non-Naive248
Rivaroxaban: Naive1191
Rivaroxaban: Non-Naive322

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Number of Participants by Comorbidity

Comorbidity was defined as the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive3695
Apixaban: Non Naive1316
Acenocoumarol: Naive26450
Acenocoumarol: Non-Naive173
Warfarin: Naive1819
Warfarin: Non-Naive318
Dabigatran: Naive2030
Dabigatran: Non-Naive870
Rivaroxaban: Naive3731
Rivaroxaban: Non-Naive1417

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Number of Participants by Comedications

Comedication was defined as the second or alternative medication used to relieve the side-effects of another medicine. (NCT03441633)
Timeframe: Up to 30 days after date of first prescription

InterventionParticipants (Count of Participants)
Apixaban: Naive4712
Apixaban: Non Naive1406
Acenocoumarol: Naive32212
Acenocoumarol: Non-Naive188
Warfarin: Naive2286
Warfarin: Non-Naive352
Dabigatran: Naive2855
Dabigatran: Non-Naive947
Rivaroxaban: Naive5132
Rivaroxaban: Non-Naive1532

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Risk of Bleeding Events: HAS-BLED Score

Risk of bleeding events was assessed by using HAS-BLED score. HAS-BLED was a scoring system that was developed to assess 1 year risk of occurrence of major hemorrhage. HAS-BLED score was assessed by combining score of 9 risk factors: hypertension history, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol or drug usage history. The total score ranged from 0 to 9 where 0 = low risk of bleed per 100 participants-year and >3 = high risk of bleed per 100 participants-year. (NCT03441633)
Timeframe: Up to 12 months prior to enrollment

Interventionbleed per 100 participants-year (Mean)
Apixaban: Naive1.7
Apixaban: Non Naive2.7
Acenocoumarol: Naive2.2
Acenocoumarol: Non-Naive2.5
Warfarin: Naive1.9
Warfarin: Non-Naive2.4
Dabigatran: Naive1.5
Dabigatran: Non-Naive2.6
Rivaroxaban: Naive1.6
Rivaroxaban: Non-Naive2.6

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Number of Participants by Their Sociodemographic Characteristics: Body Mass Index (BMI)

Socio-demographics were characteristics of a population. One of the socio-demographics characteristics included BMI. BMI was defined as an index for assessing overweight and underweight and was obtained by dividing body weight in kilograms (kg) by height in meters squared (m^2). (NCT03441633)
Timeframe: Day 1

,,,,,,,,,
InterventionParticipants (Count of Participants)
Missing18.5 - 25 kg per m^2 (Normal)Less than (<) 18.5 kg per m^2 (Underweight)25 - 30 kg per m^2 (Overweight)Greater than (>) 30 kg per m^2 (Obese)
Acenocoumarol: Naive689844711411007410628
Acenocoumarol: Non-Naive343006860
Apixaban: Naive14244231212291624
Apixaban: Non Naive2612536493410
Dabigatran: Naive96027210735878
Dabigatran: Non-Naive1781448306317
Rivaroxaban: Naive17464641612891617
Rivaroxaban: Non-Naive3112710482498
Warfarin: Naive5092956712764
Warfarin: Non-Naive8778211977

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Apixaban Adherence With VKA, Dabigatran and Rivaroxaban by Number of Defined Daily Dose (NDDD)

NDDD was a measure that represented the average daily maintenance dose for the main indication of a drug. (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventionmilligrams per day (Median)
Apixaban: Naive15.0
Apixaban: Non Naive30.0
Acenocoumarol: Naive16.0
Acenocoumarol: Non-Naive16.0
Warfarin: Naive53.0
Warfarin: Non-Naive16.0
Dabigatran: Naive22.0
Dabigatran: Non-Naive22.0
Rivaroxaban: Naive21.0
Rivaroxaban: Non-Naive28.0

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International Normalized Ratio (INR) Values During the Last 12 Months Values in Participants Previously Treated With VKA

INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time. Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication. INR was categorized according to the risk level: risk for coagulation (INR<2); optimal range (23). (NCT03441633)
Timeframe: Up to 12 months after date of first prescription

Interventionratio (Mean)
Acenocoumarol: Naive2.5
Acenocoumarol: Non-Naive2.5
Warfarin: Naive2.5
Warfarin: Non-Naive2.6

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Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)1.39
Apixaban vs Dabigatran (Dabigatran)1.12
Apixaban vs Rivaroxaban (Apixaban)1.35
Apixaban vs Rivaroxaban (Rivaroxaban)1.43
Dabigatran vs Rivaroxaban (Dabigatran)1.08
Dabigatran vs Rivaroxaban (Rivaroxaban)1.41

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Event Rate of Intracranial Hemorrhage Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of intracranial hemorrhage events after index date was reported. Intracranial hemorrhage requiring hospitalization was identified using hospital claims which had an intracranial hemorrhage KCD code (I60, I61, I62, I690, I691, I692, S064, S065, S066, and S068) and brain CT or MRI codes. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)1.37
Apixaban vs Warfarin (Warfarin)2.38
Dabigatran vs Warfarin (Dabigatran)1.17
Dabigatran vs Warfarin (Warfarin)2.31
Rivaroxaban vs Warfarin (Rivaroxaban)1.47
Rivaroxaban vs Warfarin (Warfarin)2.37

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Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)3.23
Apixaban vs Dabigatran (Dabigatran)4.18
Apixaban vs Rivaroxaban (Apixaban)3.28
Apixaban vs Rivaroxaban (Rivaroxaban)4.59
Dabigatran vs Rivaroxaban (Dabigatran)3.97
Dabigatran vs Rivaroxaban (Rivaroxaban)4.25

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Event Rate of Gastrointestinal (GI) Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of GI bleeding events after index date was reported. GI bleeding requiring hospitalization was identified using hospital claims which had a GI bleeding KCD code (I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)3.44
Apixaban vs Warfarin (Warfarin)6.2
Dabigatran vs Warfarin (Dabigatran)4.17
Dabigatran vs Warfarin (Warfarin)5.56
Rivaroxaban vs Warfarin (Rivaroxaban)4.32
Rivaroxaban vs Warfarin (Warfarin)5.78

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Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)1.11
Apixaban vs Dabigatran (Dabigatran)0.74
Apixaban vs Rivaroxaban (Apixaban)1.05
Apixaban vs Rivaroxaban (Rivaroxaban)1.15
Dabigatran vs Rivaroxaban (Dabigatran)0.71
Dabigatran vs Rivaroxaban (Rivaroxaban)1.14

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Event Rate of Hemorrhagic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was number of events divided by 100 participant-years for first occurrence of hemorrhagic stroke events after index date was reported. Hemorrhagic stroke requiring hospitalization was identified using hospital claims which had a hemorrhagic stroke KCD code (I60-62, I690-692). For hemorrhagic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)1.1
Apixaban vs Warfarin (Warfarin)1.73
Dabigatran vs Warfarin (Dabigatran)0.78
Dabigatran vs Warfarin (Warfarin)1.71
Rivaroxaban vs Warfarin (Rivaroxaban)1.18
Rivaroxaban vs Warfarin (Warfarin)1.72

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Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)7.66
Apixaban vs Warfarin (Warfarin)13.52
Dabigatran vs Warfarin (Dabigatran)7.2
Dabigatran vs Warfarin (Warfarin)13.53
Rivaroxaban vs Warfarin (Rivaroxaban)7.18
Rivaroxaban vs Warfarin (Warfarin)12.89

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Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)6.99
Apixaban vs Dabigatran (Dabigatran)6.84
Apixaban vs Rivaroxaban (Apixaban)6.60
Apixaban vs Rivaroxaban (Rivaroxaban)6.58
Dabigatran vs Rivaroxaban (Dabigatran)6.37
Dabigatran vs Rivaroxaban (Rivaroxaban)6.43

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Event Rate of Ischemic Stroke Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of ischemic stroke events after index date was reported. Ischemic stroke requiring hospitalization was identified using hospital claims which had ischemic stroke KCD code (G459, I63, and I693). For ischemic stroke, hospitalization and brain CT or MRI codes were also required. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)6.9
Apixaban vs Warfarin (Warfarin)11.8
Dabigatran vs Warfarin (Dabigatran)6.53
Dabigatran vs Warfarin (Warfarin)11.92
Rivaroxaban vs Warfarin (Rivaroxaban)6.29
Rivaroxaban vs Warfarin (Warfarin)11.19

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Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate: number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62,H448,H3572,H356,H313,H210,H113,H052,H470,H431,I312,N020-N029,N421,N831,N857,N920,N923,N930,N938-939,M250,R233,R040-042,R048-049,T792,T810,N950,R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date= first prescription date of study drugs during intake duration. Participants were identified as NOAC user/Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)7.97
Apixaban vs Warfarin (Warfarin)14.73
Dabigatran vs Warfarin (Dabigatran)8.57
Dabigatran vs Warfarin (Warfarin)13.77
Rivaroxaban vs Warfarin (Rivaroxaban)9.55
Rivaroxaban vs Warfarin (Warfarin)14.23

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Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)3.67
Apixaban vs Dabigatran (Dabigatran)4.06
Apixaban vs Rivaroxaban (Apixaban)3.73
Apixaban vs Rivaroxaban (Rivaroxaban)4.54
Dabigatran vs Rivaroxaban (Dabigatran)3.83
Dabigatran vs Rivaroxaban (Rivaroxaban)4.35

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Event Rate of Other Bleeding Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of other bleeding events after index date was reported. Other bleeding requiring hospitalization was identified using hospital claims which had other bleeding KCD code (D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938, N939, M250, R233, R040, R041, R042, R048, R049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)3.75
Apixaban vs Warfarin (Warfarin)6.93
Dabigatran vs Warfarin (Dabigatran)3.86
Dabigatran vs Warfarin (Warfarin)6.61
Rivaroxaban vs Warfarin (Rivaroxaban)4.42
Rivaroxaban vs Warfarin (Warfarin)6.85

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Event Rate of Stroke/Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years. Hemorrhagic stroke, ischemic stroke and systemic embolism requiring hospitalization identified using hospital claims which had hemorrhagic, ischemic stroke or systemic embolism Korean standard classification of diseases (KCD) code, whichever came first (first occurred event used). KCD code: hemorrhagic stroke = I60-62, I690-692; ischemic stroke = G459, I63, I693; systemic embolism = I74. Hospitalization and brain CT/MRI codes were used for ischemic stroke, hemorrhagic stroke.Hospitalization and any CT/MRI codes were used for systemic embolism. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)7.75
Apixaban vs Dabigatran (Dabigatran)7.47
Apixaban vs Rivaroxaban (Apixaban)7.35
Apixaban vs Rivaroxaban (Rivaroxaban)7.48
Dabigatran vs Rivaroxaban (Dabigatran)7.01
Dabigatran vs Rivaroxaban (Rivaroxaban)7.31

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Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date= the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)0.20
Apixaban vs Dabigatran (Dabigatran)0.25
Apixaban vs Rivaroxaban (Apixaban)0.20
Apixaban vs Rivaroxaban (Rivaroxaban)0.28
Dabigatran vs Rivaroxaban (Dabigatran)0.24
Dabigatran vs Rivaroxaban (Rivaroxaban)0.26

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Event Rate of Systemic Embolism Requiring Hospitalization: NOAC Versus Warfarin Analysis

Event rate was defined as number of events divided by 100 participant-years for first occurrence of systemic embolism. Systemic embolism requiring hospitalization was identified using hospital claims which had systemic embolism KCD code = I74. For systemic embolism, hospitalization and any CT or MRI codes was used. Index date = the first prescription date of study drugs during intake duration. Participants were identified as NOAC user or Warfarin user depending on the date when they first used NOAC or Warfarin during intake duration (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Warfarin (Apixaban)0.18
Apixaban vs Warfarin (Warfarin)0.78
Dabigatran vs Warfarin (Dabigatran)0.24
Dabigatran vs Warfarin (Warfarin)0.75
Rivaroxaban vs Warfarin (Rivaroxaban)0.27
Rivaroxaban vs Warfarin (Warfarin)0.74

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Event Rate of Major Bleeding Requiring Hospitalization: NOAC Versus NOAC Analysis

Event rate was defined as number of events divided by 100 participant-years. Intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding and other bleeding requiring hospitalization identified using hospital claims which had ICH, GI and other bleeding KCD code whichever came first (first occurred event used). KCD code: ICH = I60-62, I690-92, S064-66, S068; GI bleeding = I850, I983, K2211, K226, K228, K250, K252, K254, K256, K260, K262, K264, K266, K270, K272, K274, K276, K280, K282, K284, K286, K290, K3181, K5521, K625, K920, K921, K922; other bleeding = D62, H448, H3572, H356, H313, H210, H113, H052, H470, H431, I312, N020-N029, N421, N831, N857, N920, N923, N930, N938-939, M250, R233, R040-042, R048-049, T792, T810, N950, R310, R311, R318, R58, T455, Y442, D683). Brain CT/MRI codes were used for ICH only. Index date = the first prescription date of study drugs during intake duration. (NCT03572972)
Timeframe: Maximum of 1 year 4 months (From 1-July-2015 to 30-November-2016)

Interventionevents per 100 participants-years (Number)
Apixaban vs Dabigatran (Apixaban)7.70
Apixaban vs Dabigatran (Dabigatran)8.65
Apixaban vs Rivaroxaban (Apixaban)7.77
Apixaban vs Rivaroxaban (Rivaroxaban)9.86
Dabigatran vs Rivaroxaban (Dabigatran)8.18
Dabigatran vs Rivaroxaban (Rivaroxaban)9.36

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Andexanet Total Volume of Distribution (Vss)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Vss was calculated using a non-compartmental approach. (NCT03578146)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

InterventionL (Mean)
Module 2 PlaceboNA
Module 2 (210 mg)5.23
Module 2 (420 mg)4.65
Module 2 (600 mg)5.39
Module 2 (720 mg Bolus + 240 mg Infusion)4.17
Module 2 (800 mg Bolus + 960 mg Infusion)3.34

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Efficacy: Percent Change From Baseline in Thrombin Generation at 2 Mins Following Andexanet/Placebo Administration

Thrombin generation was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Thrombin generation was measured using a TF-initiated thrombin generation assay. (NCT03578146)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration

InterventionPercent change in thrombin generation (Mean)
Module 2 Placebo14.00
Module 2 (210 mg)107.47
Module 2 (420 mg)167.67
Module 2 (600 mg)246.02
Module 2 (720 mg Bolus + 240 mg Infusion)513.85
Module 2 (800 mg Bolus + 960 mg Infusion)559.14

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Andexanet Total Systemic Clearance (CL)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. CL was calculated using a non-compartmental approach, calculated as Dose/AUC0-inf (NCT03578146)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

InterventionL/hr (Mean)
Module 2 PlaceboNA
Module 2 (210 mg)4.15
Module 2 (420 mg)4.18
Module 2 (600 mg)4.53
Module 2 (720 mg Bolus + 240 mg Infusion)4.58
Module 2 (800 mg Bolus + 960 mg Infusion)4.23

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Andexanet Time of Maximum Observed Plasma Concentration (Tmax)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. Tmax was taken directly from the raw data. (NCT03578146)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionhr (Median)
Module 2 PlaceboNA
Module 2 (210 mg)0.17
Module 2 (420 mg)0.36
Module 2 (600 mg)0.51
Module 2 (720 mg Bolus + 240 mg Infusion)0.56
Module 2 (800 mg Bolus + 960 mg Infusion)0.52

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Andexanet Maximum Observed Plasma Concentration (Cmax)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. (NCT03578146)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionng/mL (Mean)
Module 2 PlaceboNA
Module 2 (210 mg)50400
Module 2 (420 mg)105000
Module 2 (600 mg)110000
Module 2 (720 mg Bolus + 240 mg Infusion)123000
Module 2 (800 mg Bolus + 960 mg Infusion)161000

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Andexanet Area Under the Drug Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf )

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. AUC0-inf was calculated using a non-compartmental approach (NCT03578146)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionng*hr/mL (Mean)
Module 2 PlaceboNA
Module 2 (210 mg)51400
Module 2 (420 mg)111000
Module 2 (600 mg)133000
Module 2 (720 mg Bolus + 240 mg Infusion)216000
Module 2 (800 mg Bolus + 960 mg Infusion)429000

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Andexanet Apparent Terminal Elimination Half-life (t1/2)

Plasma concentrations of andexanet was determined using a validated method that involved analysis of citrated human plasma by an electrochemiluminescent assay. t1/2 was determined by linear regression of the log concentration on the terminal portion of the plasma concentration-time curve. (NCT03578146)
Timeframe: Blood was collected at predose, 0.033, 0.2, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5 and 14.5 hours postdose.

Interventionhr (Mean)
Module 2 PlaceboNA
Module 2 (210 mg)4.97
Module 2 (420 mg)3.91
Module 2 (600 mg)4.54
Module 2 (720 mg Bolus + 240 mg Infusion)6.47
Module 2 (800 mg Bolus + 960 mg Infusion)4.45

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Efficacy: Percent Change From Baseline in Unbound Rivaroaxaban Plasma Concentration at 2 Mins Following Andexanet/Placebo Administration

Unbound rivaroxaban concentrations was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Unbound plasma concentrations for rivaroxaban were determined by a rapid equilibrium dialysis method followed by Liquid Chromatography-Mass Spectometry assay. (NCT03578146)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration

InterventionPercent change in unbound apixaban conc. (Mean)
Module 2 Placebo-11
Module 2 (210 mg)34
Module 2 (420 mg)52
Module 2 (600 mg)75
Module 2 (720 mg Bolus + 240 mg Infusion)67
Module 2 (800 mg Bolus + 960 mg Infusion)80

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Efficacy: Percent Change From Baseline in Anti-fXa Activity at 2 Mins Following Andexanet/Placebo Administration

Anti-fXa activity was measured immediately prior to (Baseline) and at 2 mins following andexanet/placebo administration. Anti-fXa activity was measured using a commercial kit (Coamatic Heparin-82 33 9363, DiaPharma) (NCT03578146)
Timeframe: Baseline to 2 minutes following the end of andexanet/placebo administration

InterventionPercent change in anti-fXa activity (Mean)
Module 2 Placebo22.37
Module 2 (210 mg)-18.09
Module 2 (420 mg)-50.59
Module 2 (600 mg)-75.26
Module 2 (720 mg Bolus + 240 mg Infusion)-88.91
Module 2 (800 mg Bolus + 960 mg Infusion)-92.72

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Platelet Aggregation Measured by VerifyNow PRU

P2Y12 reaction units (PRU) by VerifyNow of dual antiplatelet therapy vs. dual antiplatelet therapy plus rivaroxaban. VerifyNow is a turbidimetric based optical detection system which measures platelet aggregation induced by ADP as an increase in light transmittance. (NCT03718429)
Timeframe: 20 days

InterventionPRU (Mean)
Aspirin Plus Clopidogrel156
Aspirin Plus Clopidogrel Plus Rivaroxaban139
Clopidogrel Plus Rivaroxaban156
Aspirin223
Aspirin Plus Rivaroxaban217
Rivaroxaban229
Aspirin Plus Ticagrelor32
Aspirin Plus Ticagrelor Plus Rivaroxaban29
Ticagrelor Plus Rivaroxaban36
Rivaroxaban 20 mg241

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Platelet-Mediated Global Thrombogenicity

Comparison of platelet-mediated global thrombogenicity measured by light transmittance aggregometry following collagen-related peptide+adenosine diphosphate+ tissue factor (CATF) stimuli between aspirin plus clopidogrel vs. aspirin plus clopidogrel plus rivaroxaban. This was reported as maximal aggregation %. The combination of agonists included in the CATF cocktail leads to activation of multiple platelet pathways including thrombin generation and is therefore a marker of thrombus formation mediated by platelets. (NCT03718429)
Timeframe: 20 days

Interventionpercentage of aggregation (Mean)
Aspirin Plus Clopidogrel66
Aspirin Plus Clopidogrel Plus Rivaroxaban59
Clopidogrel Plus Rivaroxaban69
Aspirin71
Aspirin Plus Rivaroxaban63
Rivaroxaban74
Aspirin Plus Ticagrelor37
Aspirin Plus Ticagrelor Plus Rivaroxaban32
Ticagrelor Plus Rivaroxaban35
Rivaroxaban 20 mg75

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Thrombin Generation

Comparison of thrombin generation, reported as peak thrombin level measured by a thrombin generation assay, between aspirin plus clopidogrel vs. aspirin plus clopidogrel plus rivaroxaban. This is reflective of the amount of thrombin that is generated following stimuli with tissue factor. The theombin generation assay will be carried out using Technothrombin® fluorogenic assay kit. (NCT03718429)
Timeframe: 20 days

InterventionµM (Mean)
Aspirin Plus Clopidogrel235
Aspirin Plus Clopidogrel Plus Rivaroxaban135
Clopidogrel Plus Rivaroxaban121
Aspirin248
Aspirin Plus Rivaroxaban130
Rivaroxaban160
Aspirin Plus Ticagrelor263
Aspirin Plus Ticagrelor Plus Rivaroxaban162
Ticagrelor Plus Rivaroxaban155
Rivaroxaban 20 mg103

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Time to Maximum Plasma Concentration (Tmax) for Rivaroxaban

Time to maximum plasma concentration for Rivaroxaban following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 was analyzed using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). Tmax for rivaroxaban was obtained directly by visual inspection of the plasma concentration versus time over 24 hours postdose. (NCT03864406)
Timeframe: Up to 24 hours postdose on days 1, 7, and 13

InterventionHours (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers2.54.13.02

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Terminal Elimination Half-life (t½) for Rivaroxaban

Terminal elimination half-life (t½) for Rivaroxaban following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 was analyzed using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). The apparent elimination rate constant (λZ) was determined by calculating the absolute value of the slope of the log-linear regression of at least 3 points of the plasma concentration-time plot. The t½ was calculated as 0.693/apparent elimination rate constant (λZ). (NCT03864406)
Timeframe: Up to 24 hours postdose on days 1, 7, and 13

InterventionHours (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers5.658.197.49

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Minimum Total Plasma Concentration (Cmin) for Rivaroxaban

Minimum total plasma concentration (Cmin) for Rivaroxaban following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 was analyzed using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). Cmin for rivaroxaban was obtained directly by visual inspection of the plasma concentration versus times over 24 hours postdose. (NCT03864406)
Timeframe: Up to 24 hours postdose on days 1, 7, and 13

Interventionng/mL (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers6.9327.3224.43

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Maximum Total Plasma Concentration (Cmax) for Rivaroxaban

Maximum total plasma concentration (Cmax) following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 was analyzed using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). Cmax for rivaroxaban was obtained directly by visual inspection of the plasma concentration versus time over 24 hours postdose. (NCT03864406)
Timeframe: Up to 24 hours postdose on days 1, 7, and 13

Interventionng/mL (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers128.6192.25196.17

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Area Under the Concentration Versus Time Curve (AUC0-24hr) for Rivaroxaban

Area under the concentration versus time curve from (AUC0-24hr) following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 to measure total drug exposure was analyzed by the linear up/log down trapezoidal rule using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). (NCT03864406)
Timeframe: 0 to 24 hours postdose on days 1, 7, and 13

Interventionhr*ng/ml (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers991.251929.781939

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Area Under the Concentration Versus Time Curve (AUC0-∞) for Rivaroxaban

Area under the concentration versus time curve from 0 to infinity (AUC0-∞) following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 to measure the total drug exposure was analyzed by the linear up/log down trapezoidal rule using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). (NCT03864406)
Timeframe: Total drug exposure at time point zero to infinity on days 1, 7, & 13

Interventionhr*ng/ml (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers1049.192274.32226.38

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Apparent Volume of Distribution (V/F) for Rivaroxaban

Apparent volume of distribution (V/F) for Rivaroxaban following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 was analyzed using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). (NCT03864406)
Timeframe: Up to 24 hours postdose on days 1, 7, and 13

InterventionLiter (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers89.9456.2252.84

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Apparent Oral Clearance (CL/F) for Rivaroxaban

Apparent oral clearance (CL/F) for Rivaroxaban following a single dose of rivaroxaban 10 mg orally on days 1, 7, and 13 was analyzed using noncompartmental methods with Phoenix WinNonlin® (version 8.0; Pharsight Corporation, Mountain View, CA). CL/F was calculated as 10 mg ÷ AUC0-tau for rivaroxaban. (NCT03864406)
Timeframe: Up to 24 hours postdose on days 1, 7, and 13

InterventionL/hr (Mean)
Day 1 (phase 1)Day 7 (phase 2)Day 13 (phase 3)
Pharmacokinetic Study in Healthy Volunteers11.044.925.19

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Maximal Platelet Aggregation (MPA%) by Light Transmittance Aggregometry (LTA)

The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen (NCT04006288)
Timeframe: 30 days

Interventionpercentage of MPA (Median)
Aspirin and Clopidogrel27
Aspirin and Rivaroxaban From Aspirin and Clopidogrel53
Aspirin and Prasugrel20
Aspirin and Rivaroxaban From Aspirin and Prasugrel4
Aspirin and Ticagrelor15
Aspirin and Rivaroxaban From Aspirin and Ticagrelor20

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Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale Through Day 28

Participants who progressed to a moderate or severe disease category or higher (Bill & Melinda Gates Medical Research Institute [Gates MRI] ordinal scale ≥3) are reported. Gates MRI scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with Extra-Corporeal Membrane Oxygenation (ECMO); 7=Death. (NCT04504032)
Timeframe: Up to Day 28

InterventionParticipants (Count of Participants)
Rivaroxaban46
Placebo44

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Number of Participants With AEs Resulting in Study Intervention Discontinuation Through Day 35

An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. (NCT04504032)
Timeframe: Up to Day 35

InterventionParticipants (Count of Participants)
Rivaroxaban4
Placebo5

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Number of Participants With Grade 3 and Grade 4 Adverse Events (AEs) Through Day 35

An AE is any untoward medical occurrence that occurs in a participant. An AE can be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with treatment, whether considered related to the product. AEs may include the onset of a new illness or undesirable medical condition or the exacerbation of pre-existing medical conditions. AE severity was graded as Grade 3 (Severe) and Grade 4 (Potentially Life-threatening) per the specific toxicity grading by the Division of Acquired Immunodeficiency Syndrome (DAIDS) AE Grading Table. (NCT04504032)
Timeframe: Up to Day 35

InterventionParticipants (Count of Participants)
Rivaroxaban6
Placebo13

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Number of Participants With Serious Adverse Events Through Day 35

A serious AE is any untoward medical occurrence or effect, that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is an important medical event that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes. (NCT04504032)
Timeframe: Up to Day 35

InterventionParticipants (Count of Participants)
Rivaroxaban2
Placebo7

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Number of Participants Who Achieved Disease Resolution Based on Symptoms Resolution at Days 8, 14, 21, and 28

Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. (NCT04504032)
Timeframe: Days 8, 14, 21, and 28

,
InterventionParticipants (Count of Participants)
Day 8Day 14Day 21Day 28
Placebo305993122
Rivaroxaban2664100132

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Number of Participants Who Progressed to Moderate or Severe Disease or Higher Based on the Gates MRI Ordinal Scale at Day 8, 14, and 21

Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. (NCT04504032)
Timeframe: Days 8, 14, and 21

,
InterventionParticipants (Count of Participants)
Day 8Day 14Day 21
Placebo364042
Rivaroxaban384445

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Number of Participants With Hospitalization Through Days 8, 14, 21, and 28

Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed. (NCT04504032)
Timeframe: Days 8, 14, 21, and 28

,
InterventionParticipants (Count of Participants)
Up to Day 8Up to Day 14Up to Day 21Up to Day 28
Placebo6777
Rivaroxaban3333

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Shift in Gates Medical Research Institute Ordinal Scale Score at Days 8, 14, 21, and 28

Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. BS= Baseline; PBS= Post-Baseline; NA= Data not available. (NCT04504032)
Timeframe: Days 8, 14, 21, and 28

,
InterventionParticipants (Number)
Day 8: shift from BS score 1 to PBS score 1Day 8: shift from BS score 1 to PBS score 2Day 8: shift from BS score 1 to PBS score 3Day 8: shift from BS score 1 to PBS score >=4Day 8: shift from BS score 1 to PBS score NADay 8: shift from BS score 2 to PBS score 1Day 8: shift from BS score 2 to PBS score 2Day 8: shift from BS score 2 to PBS score 3Day 8: shift from BS score 2 to PBS score >=4Day 8: shift from BS score 2 to PBS score NADay 8: shift from BS score 3 to PBS score 1Day 8: shift from BS score 3 to PBS score 2Day 8: shift from BS score 3 to PBS score 3Day 8: shift from BS score 3 to PBS score >=4Day 8: shift from BS score 3 to PBS score NADay 8: shift from BS score NA to PBS score 1Day 8: shift from BS score NA to PBS score 2Day 8: shift from BS score NA to PBS score 3Day 8: shift from BS score NA to PBS score >=4Day 8: shift from BS score NA to PBS score NADay 14: shift from BS score 1 to PBS score 1Day 14: shift from BS score 1 to PBS score 2Day 14: shift from BS score 1 to PBS score 3Day 14: shift from BS score 1 to PBS score >=4Day 14: shift from BS score 1 to PBS score NADay 14: shift from BS score 2 to PBS score 1Day 14: shift from BS score 2 to PBS score 2Day 14: shift from BS score 2 to PBS score 3Day 14: shift from BS score 2 to PBS score >=4Day 14: shift from BS score 2 to PBS score NADay 14: shift from BS score 3 to PBS score 1Day 14: shift from BS score 3 to PBS score 2Day 14: shift from BS score 3 to PBS score 3Day 14: shift from BS score 3 to PBS score >=4Day 14: shift from BS score 3 to PBS score NADay 14: shift from BS score NA to PBS score 1Day 14: shift from BS score NA to PBS score 2Day 14: shift from BS score NA to PBS score 3Day 14: shift from BS score NA to PBS score >=4Day 14: shift from BS score NA to PBS score NADay 21: shift from BS score 1 to PBS score 1Day 21: shift from BS score 1 to PBS score 2Day 21: shift from BS score 1 to PBS score 3Day 21: shift from BS score 1 to PBS score >=4Day 21: shift from BS score 1 to PBS score NADay 21: shift from BS score 2 to PBS score 1Day 21: shift from BS score 2 to PBS score 2Day 21: shift from BS score 2 to PBS score 3Day 21: shift from BS score 2 to PBS score >=4Day 21: shift from BS score 2 to PBS score NADay 21: shift from BS score 3 to PBS score 1Day 21: shift from BS score 3 to PBS score 2Day 21: shift from BS score 3 to PBS score 3Day 21: shift from BS score 3 to PBS score >=4Day 21: shift from BS score 3 to PBS score NADay 21: shift from BS score NA to PBS score 1Day 21: shift from BS score NA to PBS score 2Day 21: shift from BS score NA to PBS score 3Day 21: shift from BS score NA to PBS score >=4Day 21: shift from BS score NA to PBS score NADay 28: shift from BS score 1 to PBS score 1Day 28: shift from BS score 1 to PBS score 2Day 28: shift from BS score 1 to PBS score 3Day 28: shift from BS score 1 to PBS score >=4Day 28: shift from BS score 1 to PBS score NADay 28: shift from BS score 2 to PBS score 1Day 28: shift from BS score 2 to PBS score 2Day 28: shift from BS score 2 to PBS score 3Day 28: shift from BS score 2 to PBS score >=4Day 28: shift from BS score 2 to PBS score NADay 28: shift from BS score 3 to PBS score 1Day 28: shift from BS score 3 to PBS score 2Day 28: shift from BS score 3 to PBS score 3Day 28: shift from BS score 3 to PBS score >=4Day 28: shift from BS score 3 to PBS score NADay 28: shift from BS score NA to PBS score 1Day 28: shift from BS score NA to PBS score 2Day 28: shift from BS score NA to PBS score 3Day 28: shift from BS score NA to PBS score >=4Day 28: shift from BS score NA to PBS score NA
Placebo100003015880400003000017100005413170801003000017000017810950810003000017100001068140910003000017
Rivaroxaban2000031152307000012000015200006711430900001200001520000968710900001200001520000123571012000012000015

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Shift in World Health Organization Ordinal Scale Score at Days 8, 14, 21, and 28

The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO; 10=Dead. BS= Baseline; PBS= Post-Baseline; NA= Data not available. (NCT04504032)
Timeframe: Baseline; Days 8, 14, 21, and 28

,
InterventionParticipants (Number)
Day 8: shift from BS score 0 to PBS score 0Day 8: shift from BS score 0 to PBS score 1Day 8: shift from BS score 0 to PBS score 2Day 8: shift from BS score 0 to PBS score 3Day 8: shift from BS score 0 to PBS score 4Day 8: shift from BS score 0 to PBS score 5Day 8: shift from BS score 0 to PBS score >=6Day 8: shift from BS score 0 to PBS score NADay 8: shift from BS score 1 to PBS score 0Day 8: shift from BS score 1 to PBS score 1Day 8: shift from BS score 1 to PBS score 2Day 8: shift from BS score 1 to PBS score 3Day 8: shift from BS score 1 to PBS score 4Day 8: shift from BS score 1 to PBS score 5Day 8: shift from BS score 1 to PBS score >=6Day 8: shift from BS score 1 to PBS score NADay 8: shift from BS score 2 to PBS score 0Day 8: shift from BS score 2 to PBS score 1Day 8: shift from BS score 2 to PBS score 2Day 8: shift from BS score 2 to PBS score 3Day 8: shift from BS score 2 to PBS score 4Day 8: shift from BS score 2 to PBS score 5Day 8: shift from BS score 2 to PBS score >=6Day 8: shift from BS score 2 to PBS score NADay 8: shift from BS score 3 to PBS score 0Day 8: shift from BS score 3 to PBS score 1Day 8: shift from BS score 3 to PBS score 2Day 8: shift from BS score 3 to PBS score 3Day 8: shift from BS score 3 to PBS score 4Day 8: shift from BS score 3 to PBS score 5Day 8: shift from BS score 3 to PBS score >=6Day 8: shift from BS score 3 to PBS score NADay 8: shift from BS score NA to PBS score 0Day 8: shift from BS score NA to PBS score 1Day 8: shift from BS score NA to PBS score 2Day 8: shift from BS score NA to PBS score 3Day 8: shift from BS score NA to PBS score 4Day 8: shift from BS score NA to PBS score 5Day 8: shift from BS score NA to PBS score >=6Day 8: shift from BS score NA to PBS score NADay 14: shift from BS score 0 to PBS score 0Day 14: shift from BS score 0 to PBS score 1Day 14: shift from BS score 0 to PBS score 2Day 14: shift from BS score 0 to PBS score 3Day 14: shift from BS score 0 to PBS score 4Day 14: shift from BS score 0 to PBS score 5Day 14: shift from BS score 0 to PBS score >=6Day 14: shift from BS score 0 to PBS score NADay 14: shift from BS score 1 to PBS score 0Day 14: shift from BS score 1 to PBS score 1Day 14: shift from BS score 1 to PBS score 2Day 14: shift from BS score 1 to PBS score 3Day 14: shift from BS score 1 to PBS score 4Day 14: shift from BS score 1 to PBS score 5Day 14: shift from BS score 1 to PBS score >=6Day 14: shift from BS score 1 to PBS score NADay 14: shift from BS score 2 to PBS score 0Day 14: shift from BS score 2 to PBS score 1Day 14: shift from BS score 2 to PBS score 2Day 14: shift from BS score 2 to PBS score 3Day 14: shift from BS score 2 to PBS score 4Day 14: shift from BS score 2 to PBS score 5Day 14: shift from BS score 2 to PBS score >=6Day 14: shift from BS score 2 to PBS score NADay 14: shift from BS score 3 to PBS score 0Day 14: shift from BS score 3 to PBS score 1Day 14: shift from BS score 3 to PBS score 2Day 14: shift from BS score 3 to PBS score 3Day 14: shift from BS score 3 to PBS score 4Day 14: shift from BS score 3 to PBS score 5Day 14: shift from BS score 3 to PBS score >=6Day 14: shift from BS score 3 to PBS score NADay 14: shift from BS score NA to PBS score 0Day 14: shift from BS score NA to PBS score 1Day 14: shift from BS score NA to PBS score 2Day 14: shift from BS score NA to PBS score 3Day 14: shift from BS score NA to PBS score 4Day 14: shift from BS score NA to PBS score 5Day 14: shift from BS score NA to PBS score >=6Day 14: shift from BS score NA to PBS score NADay 21: shift from BS score 0 to PBS score 0Day 21: shift from BS score 0 to PBS score 1Day 21: shift from BS score 0 to PBS score 2Day 21: shift from BS score 0 to PBS score 3Day 21: shift from BS score 0 to PBS score 4Day 21: shift from BS score 0 to PBS score 5Day 21: shift from BS score 0 to PBS score >=6Day 21: shift from BS score 0 to PBS score NADay 21: shift from BS score 1 to PBS score 0Day 21: shift from BS score 1 to PBS score 1Day 21: shift from BS score 1 to PBS score 2Day 21: shift from BS score 1 to PBS score 3Day 21: shift from BS score 1 to PBS score 4Day 21: shift from BS score 1 to PBS score 5Day 21: shift from BS score 1 to PBS score >=6Day 21: shift from BS score 1 to PBS score NADay 21: shift from BS score 2 to PBS score 0Day 21: shift from BS score 2 to PBS score 1Day 21: shift from BS score 2 to PBS score 2Day 21: shift from BS score 2 to PBS score 3Day 21: shift from BS score 2 to PBS score 4Day 21: shift from BS score 2 to PBS score 5Day 21: shift from BS score 2 to PBS score >=6Day 21: shift from BS score 2 to PBS score NADay 21: shift from BS score 3 to PBS score 0Day 21: shift from BS score 3 to PBS score 1Day 21: shift from BS score 3 to PBS score 2Day 21: shift from BS score 3 to PBS score 3Day 21: shift from BS score 3 to PBS score 4Day 21: shift from BS score 3 to PBS score 5Day 21: shift from BS score 3 to PBS score >=6Day 21: shift from BS score 3 to PBS score NADay 21: shift from BS score NA to PBS score 0Day 21: shift from BS score NA to PBS score 1Day 21: shift from BS score NA to PBS score 2Day 21: shift from BS score NA to PBS score 3Day 21: shift from BS score NA to PBS score 4Day 21: shift from BS score NA to PBS score 5Day 21: shift from BS score NA to PBS score >=6Day 21: shift from BS score NA to PBS score NADay 28: shift from BS score 0 to PBS score 0Day 28: shift from BS score 0 to PBS score 1Day 28: shift from BS score 0 to PBS score 2Day 28: shift from BS score 0 to PBS score 3Day 28: shift from BS score 0 to PBS score 4Day 28: shift from BS score 0 to PBS score 5Day 28: shift from BS score 0 to PBS score >=6Day 28: shift from BS score 0 to PBS score NADay 28: shift from BS score 1 to PBS score 0Day 28: shift from BS score 1 to PBS score 1Day 28: shift from BS score 1 to PBS score 2Day 28: shift from BS score 1 to PBS score 3Day 28: shift from BS score 1 to PBS score 4Day 28: shift from BS score 1 to PBS score 5Day 28: shift from BS score 1 to PBS score >=6Day 28: shift from BS score 1 to PBS score NADay 28: shift from BS score 2 to PBS score 0Day 28: shift from BS score 2 to PBS score 1Day 28: shift from BS score 2 to PBS score 2Day 28: shift from BS score 2 to PBS score 3Day 28: shift from BS score 2 to PBS score 4Day 28: shift from BS score 2 to PBS score 5Day 28: shift from BS score 2 to PBS score >=6Day 28: shift from BS score 2 to PBS score NADay 28: shift from BS score 3 to PBS score 0Day 28: shift from BS score 3 to PBS score 1Day 28: shift from BS score 3 to PBS score 2Day 28: shift from BS score 3 to PBS score 3Day 28: shift from BS score 3 to PBS score 4Day 28: shift from BS score 3 to PBS score 5Day 28: shift from BS score 3 to PBS score >=6Day 28: shift from BS score 3 to PBS score NADay 28: shift from BS score NA to PBS score 0Day 28: shift from BS score NA to PBS score 1Day 28: shift from BS score NA to PBS score 2Day 28: shift from BS score NA to PBS score 3Day 28: shift from BS score NA to PBS score 4Day 28: shift from BS score NA to PBS score 5Day 28: shift from BS score NA to PBS score >=6Day 28: shift from BS score NA to PBS score NA
Placebo0000000010000000181216610007000000000000000170000000010000000391613710001100000000000000017000000000000000172811210001100000000000000017000000001000000010548210001200000000000000017
Rivaroxaban20000000000000001714154010018000000010000000152000000000000000541511500002000000001000000015200000000000000085128700002000000001000000015200000000000000011595700002300000001000000015

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Median Number of Days of Hospitalization Through Day 35

Participants who had clinical worsening and who had at least one hospitalization during the study were analyzed. Hospitalized participants without an end date of hospitalization were not included. (NCT04504032)
Timeframe: Up to Day 35

InterventionDays (Median)
Rivaroxaban5.0
Placebo4.0

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Median Time to Disease Resolution Based on Symptoms Resolution Through Day 28

Time to disease resolution is defined as the time from the first dose to the date of symptoms resolution (new-onset Coronavirus Disease 2019 [COVID-19] symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% confidence interval (CI) for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates. (NCT04504032)
Timeframe: Up to Day 28

InterventionDays (Median)
Rivaroxaban21.0
Placebo23.0

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Number of Participants Who Achieved Disease Resolution Based on Viral Clearance and Symptoms Resolution at Days 8, 14, 21, and 28

Viral clearance is defined as two consecutive negative diagnostic tests. Symptoms resolution is defined as new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. (NCT04504032)
Timeframe: Days 8, 14, 21, and 28

,
InterventionParticipants (Count of Participants)
Day 8Day 14Day 21Day 28
Placebo204483115
Rivaroxaban124986125

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Number of Participants With the Indicated World Health Organization (WHO) Ordinal Scale Clinical Status at Days 8, 14, 21, and 28

The WHO ordinal scale score is used to analyze the overall burden of disease and disease severity using an 11-point scale ranging from 0 to 10: 0=Uninfected; No viral ribonucleic acid (RNA) detected; 1=Asymptomatic; viral RNA detected; 2=Symptomatic; independent; 3=Symptomatic; assistance needed; 4=Hospitalized; no oxygen therapy (for isolation only); 5=Hospitalized; oxygen by mask or nasal prongs; 6=Hospitalized; oxygen by non-invasive ventilation (NIV) or high flow; 7=Intubation and mechanical ventilation, partial pressure of oxygen (pO2)/fraction of inspired oxygen (FiO2) ≥150 or oxygen saturation (SpO2)/FiO2 ≥200; 8=Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or Vasopressors; 9=Mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis, or ECMO; 10=Dead. (NCT04504032)
Timeframe: Days 8, 14, 21, and 28

InterventionParticipants (Count of Participants)
Day 872489465Day 872489466Day 1472489466Day 1472489465Day 2172489466Day 2172489465Day 2872489466Day 2872489465
Score 0Score 1Score 2Score 3Score 4Score 5Score 6Score 7Score 8Score 9Score 10
Rivaroxaban19
Placebo19
Rivaroxaban14
Placebo12
Rivaroxaban154
Placebo166
Rivaroxaban1
Placebo0
Rivaroxaban56
Placebo40
Rivaroxaban15
Placebo16
Rivaroxaban115
Placebo137
Placebo72
Rivaroxaban12
Placebo8
Rivaroxaban87
Placebo112
Rivaroxaban117
Placebo106
Rivaroxaban9
Placebo4
Rivaroxaban57
Placebo82
Placebo1
Rivaroxaban0

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Number of Participants With the Indicated Gates Medical Research Institute (MRI) Scale Clinical Status at Days 8, 14, 21, and 28

Participants who progressed to a moderate or severe disease category or higher (Gates MRI ordinal scale ≥3) are reported. Gates MRI ordinal scale scores are assessed on a 7-point scale: 1=Asymptomatic/symptoms similar to pre-COVID-19 status; 2=Mild; 3=Moderate or severe; 4=Critically ill; 5=Critically ill with invasive mechanical ventilation or extrapulmonary complication; 6=Critically ill with ECMO; 7=Death. (NCT04504032)
Timeframe: Days 8, 14, 21, and 28

InterventionParticipants (Count of Participants)
Day 872489466Day 872489465Day 1472489466Day 1472489465Day 2172489465Day 2172489466Day 2872489465Day 2872489466
Score 1Score 3Score 4Score 5Score 2Score 6Score 7
Rivaroxaban33
Placebo31
Rivaroxaban152
Placebo159
Rivaroxaban3
Placebo8
Placebo0
Rivaroxaban69
Placebo55
Rivaroxaban114
Placebo132
Placebo7
Rivaroxaban0
Rivaroxaban98
Placebo79
Rivaroxaban87
Placebo109
Placebo5
Rivaroxaban125
Placebo108
Rivaroxaban57
Placebo81
Rivaroxaban1
Placebo4

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Median Time to Disease Resolution Based on Viral Clearance and Symptoms Resolution Through Day 28

Time to disease resolution is defined as the time from the first dose to the date of both viral clearance (two consecutive negative diagnostic tests) and symptoms resolution (new-onset COVID-19 symptoms resolved, and pre-existing symptoms returned to Baseline) through Day 28. Baseline refers to health status prior to contracting new-onset COVID-19 symptoms. The 95% CI for median and quartiles of time to disease resolution were calculated using the Kaplan Meier estimates. (NCT04504032)
Timeframe: Up to Day 28

InterventionDays (Median)
Rivaroxaban23.0
Placebo26.0

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Number of Participants Who Were Hospitalized or Dead on Day 35

Number of participants who were hospitalized or dead on Day 35 were reported. (NCT04508023)
Timeframe: At Day 35 (+/- 6 days)

InterventionParticipants (Count of Participants)
Rivaroxaban 10 Milligrams (mg)5
Placebo3

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Number of Participants With Time to First Occurrence of Primary Efficacy Composite Endpoint

Number of participants with time to first occurrence of primary efficacy composite endpoint were reported. Time to first occurrence of primary efficacy composite endpoint is defined as time from randomization to first occurrence of any component of the primary endpoint. The components were: symptomatic venous thromboembolism (VTE), myocardial infarction (MI), ischemic stroke, acute limb ischemia, non-central nervous system (non-CNS) systemic embolization, all-cause hospitalization, and all-cause mortality. (NCT04508023)
Timeframe: Up to Day 35

InterventionParticipants (Count of Participants)
Rivaroxaban 10 Milligrams (mg)22
Placebo19

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Number of Participants With Time to the First Occurrence of Secondary Efficacy Outcomes

Number of participants with time to the first occurrence of secondary efficacy outcomes which included thrombotic events (symptomatic VTE, myocardial infarction, ischemic stroke, acute limb ischemia, non-CNS systemic embolization), emergency room (ER) visit, all-cause mortality, all-cause hospitalization, any thrombotic outcome and all-cause mortality, and any thrombotic outcome and all-cause hospitalization, were reported. (NCT04508023)
Timeframe: From Day 1 up to Day 35

,
InterventionParticipants (Count of Participants)
Symptomatic VTEMyocardial InfractionIschemic strokeAcute limb ischemiaNon-CNS systemic embolizationER VisitAll-cause hospitalizationAll-cause MortalityAny Thrombotic Outcome and All-cause MortalityAny Thrombotic Outcome and All-cause Hospitalization
Placebo3020034172717
Rivaroxaban 10 Milligrams (mg)0000026212221

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Number of Participants With Time to First Occurrence of The Principle Safety Outcome (Fatal Bleeding and Critical Site Bleeding) Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria

Number of participants with time to first occurrence of the principle safety outcome (fatal bleeding and critical site bleeding) based on a Modification of the ISTH criteria were reported. Fatal bleeding is defined as any bleeding event that leads to fatal outcome. Critical site bleeding defined as any bleeding event that occurred at critical site such as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal. (NCT04508023)
Timeframe: Up to Day 35

,
InterventionParticipants (Count of Participants)
Fatal BleedingCritical Site Bleeding
Placebo00
Rivaroxaban 10 Milligrams (mg)00

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Number of Participants With Time to First Occurrence of Major Bleeding Based on a Modification of the ISTH Criteria

Number of participants with time to first occurrence of the major bleeding based on a modification of the ISTH criteria were reported. Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 grams per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome. (NCT04508023)
Timeframe: Up to Day 35

InterventionParticipants (Count of Participants)
Rivaroxaban 10 Milligrams (mg)1
Placebo0

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Number of Participants Who Completely Discontinued Index Anticoagulant Treatment

Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy198262570
NOAC-Based Therapy: Apixaban2828279
NOAC-Based Therapy: Dabigatran1028115
NOAC-Based Therapy: Edoxaban1164147
NOAC-Based Therapy: Rivaroxaban141701968
PAC Only45341449
Warfarin-Based Therapy4707444

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only146511510362182529

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy13623

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban105115822113

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban481330152588411

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban2143901000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban61191410010

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Number of Participants Who Switched to Another Anticoagulant Therapy

Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy1273173
NOAC-Based Therapy: Apixaban31933
NOAC-Based Therapy: Dabigatran27630
NOAC-Based Therapy: Edoxaban20426
NOAC-Based Therapy: Rivaroxaban1777208
PAC Only535208
Warfarin-Based Therapy1541144

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy17023012000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran2112100001

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1020100001

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran3011600003

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0004201000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Surgery

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major surgery are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy26314318310012

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Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 6 Months

Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 6 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy105571089
NOAC-Based Therapy: Apixaban1213125
NOAC-Based Therapy: Dabigatran60646
NOAC-Based Therapy: Edoxaban81791
NOAC-Based Therapy: Rivaroxaban7209773
PAC Only75221
Warfarin-Based Therapy4393217

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy5111

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only5111127000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0003000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0010100000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1010000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Major Bleeding

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event major bleeding are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban4192311102

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy361130

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only102954516171006

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy63736351130010

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban3002610000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran4111200000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban1012600001

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Liver Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event liver function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban28101342020201

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only541012121010

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Number of Participants Who Were Persistent on Index Anticoagulant Treatment for 3 Months

Participants were considered to be persistent on index anticoagulant treatment if a participant had evidence of a repeat prescription within 30 days of the end of their prescription and does not experience any of the events that included treatment interruption (participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after 30 days), switch (prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug), or discontinuation (participant ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time). Index date: date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: Within 3 months of index date, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC Based Therapy: Apixaban2390290
NOAC Based Therapy: Dabigatran1225120
NOAC Based Therapy: Edoxaban1395148
NOAC-Based Therapy198482405
NOAC-Based Therapy: Rivaroxaban140371770
PAC Only222673
Warfarin-Based Therapy6313388

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban1310200000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban11010200000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0000201000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy13524

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban0010100000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active Cancer
NOAC-Based Therapy: Rivaroxaban122101123001

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy12000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only120002000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy200100000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Apixaban0001000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Dabigatran0000000000

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Complications of VTE

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event complications of VTE are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Rivaroxaban: With Active Cancer
NOAC-Based Therapy: Edoxaban0000000000

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Time to Treatment Switch

Treatment switching was defined as a prescription of another anticoagulant therapy that was started after the treatment initiation of the index anticoagulant treatment and within 30 days after the estimated end of supply of the index anticoagulant drug (exposure to the new anticoagulant treatment must last for at least 30 days to be considered as a treatment switch). The time to treatment switch was defined as the period from the index date to the date of treatment switch. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment switch, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy17976
NOAC-Based Therapy: Apixaban6644
NOAC-Based Therapy: Dabigatran10560
NOAC-Based Therapy: Edoxaban8798
NOAC-Based Therapy: Rivaroxaban9953
PAC Only2749
Warfarin-Based Therapy5736

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Time to Treatment Interruption

Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The time to treatment interruption was defined as the period from the index date to the date of treatment interruption. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy129137
NOAC-Based Therapy: Apixaban86123
NOAC-Based Therapy: Dabigatran137119
NOAC-Based Therapy: Edoxaban130159
NOAC-Based Therapy: Rivaroxaban128134
PAC Only361
Warfarin-Based Therapy163129

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Kidney Function Change

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event kidney function change are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy22631117201001

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Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Interruption

Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment interruption. Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment interruption during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Major Bleeding: Without Active CancerComplications of VTE: Without Active CancerThromboembolism: Without Active CancerMajor Surgery: Without Active CancerCancer-related Event: Without Active CancerKidney Function Changes: Without Active CancerLiver Function Change: Without Active CancerMajor Bleeding: With Active CancerComplications of VTE: With Active CancerThromboembolism: With Active CancerMajor Surgery: With Active CancerKidney Function Changes: With Active CancerLiver Function Change: With Active Cancer
NOAC-Based Therapy53133285661268715881213389
NOAC-Based Therapy: Apixaban5050126141012303113
NOAC-Based Therapy: Dabigatran23199587001201
NOAC-Based Therapy: Edoxaban201817476000100
NOAC-Based Therapy: Rivaroxaban4210233407995512940172775
PAC Only45209171100447220955109
Warfarin-Based Therapy2761589262457911121512

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Number of Participants With Clinical Events Preceding Index Anticoagulant Treatment Discontinuation

Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment discontinuation. Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. (NCT05022563)
Timeframe: Within 30 days before treatment discontinuation during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Major Bleeding: Without Active CancerComplications of VTE: Without Active CancerThromboembolism: Without Active CancerMajor Surgery: Without Active CancerCancer-related Event: Without Active CancerKidney Function Changes: Without Active CancerLiver Function Change: Without Active CancerMajor Bleeding: With Active CancerComplications of VTE: With Active CancerThromboembolism: With Active CancerMajor Surgery: With Active CancerKidney Function Changes: With Active CancerLiver Function Change: With Active Cancer
NOAC-Based Therapy118257771691307240452362122666450
NOAC-Based Therapy: Apixaban1341235084039654014773
NOAC-Based Therapy: Dabigatran724818141334209112
NOAC-Based Therapy: Edoxaban5353252011280011553
NOAC-Based Therapy: Rivaroxaban9015537113823217232129287525142
PAC Only2018734625291383441140891904834
Warfarin-Based Therapy4210258781331041587117111416

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Overall Index Anticoagulant Treatment Duration

Overall anticoagulant treatment duration was defined as the time period from the index date to the earliest of treatment interruption, switch, or discontinuation. Treatment interruption: when a participant had a gap with no new treatment within 30 days of estimated end of supply of index treatment, but subsequently restarted index treatment after this period of 30 days. Treatment switching: a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Treatment discontinuation: when a participant who ended their first continuous treatment episode with index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to the earliest of treatment interruption, switch, or discontinuation; during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC Based Therapy: Apixaban96104
NOAC Based Therapy: Dabigatran137105
NOAC Based Therapy: Edoxaban164123
NOAC-Based Therapy140111
NOAC-Based Therapy: Rivaroxaban128102
PAC Only334
Warfarin-Based Therapy13980

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Number of Participants With Interruption in Index Anticoagulant Treatment

Treatment interruption was defined as when a participant had a gap with no new treatment within 30 days of the estimated end of supply of index treatment, but subsequently restarted the index treatment after this period of 30 days. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment interruption, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

,,,,,,
InterventionParticipants (Count of Participants)
Without Active CancerWith Active Cancer
NOAC-Based Therapy8169961
NOAC-Based Therapy: Apixaban965115
NOAC-Based Therapy: Dabigatran49251
NOAC-Based Therapy: Edoxaban43938
NOAC-Based Therapy: Rivaroxaban5973728
PAC Only1226401
Warfarin-Based Therapy3429172

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to PAC: With Active Cancer
NOAC-Based Therapy591599

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to Warfarin: Without Active CancerSwitched to NOAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to Warfarin: With Active CancerSwitched to NOAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
PAC Only125163636481115

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Number of Participants With Clinical Events Preceding Switch From Index Anticoagulant Treatment: Thromboembolism

"Clinical event preceding first treatment change was defined as occurrence of any event (major bleeding, complications of VTE, thromboembolism, major surgeries, cancer-related event, kidney function change, liver function change) within 30 days before treatment switch. Treatment switching was defined as a prescription of another anticoagulant therapy that was started after treatment initiation of index anticoagulant treatment and within 30 days after estimated end of supply of index anticoagulant drug. Index date was defined as date of first prescription for anticoagulants within 30 days after index VTE event. In this outcome measure, results for event thromboembolism are reported." (NCT05022563)
Timeframe: Within 30 days before treatment switch during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

InterventionParticipants (Count of Participants)
Switched to NOAC: Without Active CancerSwitched to PAC: Without Active CancerSwitched to Apixaban: Without Active CancerSwitched to Dabigatran: Without Active CancerSwitched to Edoxaban: Without Active CancerSwitched to Rivaroxaban: Without Active CancerSwitched to NOAC: With Active CancerSwitched to PAC: With Active CancerSwitched to Apixaban: With Active CancerSwitched to Dabigatran: With Active CancerSwitched to Edoxaban: With Active CancerSwitched to Rivaroxaban: With Active Cancer
Warfarin-Based Therapy1085897851271308

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Time to Treatment Discontinuation

Treatment discontinuation (complete discontinuation; no reinitiation) was defined as when a participant who ended their first continuous treatment episode with the index anticoagulant treatment without switching, and subsequently have no further prescriptions for that respective anticoagulant treatment during all available follow-up time. The time to treatment discontinuation was defined as the period from the index date to the date of treatment discontinuation. The index date was defined as the date of first prescription for anticoagulants within 30 days after the index VTE event. (NCT05022563)
Timeframe: From index date up to treatment discontinuation, during observation period of maximum up to 88 months (retrospective data was retrieved and observed during 1 month of this study)

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InterventionDays (Median)
Without Active CancerWith Active Cancer
NOAC-Based Therapy119101
NOAC-Based Therapy: Apixaban8499
NOAC-Based Therapy: Dabigatran134118
NOAC-Based Therapy: Edoxaban154112
NOAC-Based Therapy: Rivaroxaban11997
PAC Only225
Warfarin-Based Therapy12975

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