dalteparin has been researched along with Cardiac Failure in 30 studies
Dalteparin: A low-molecular-weight fragment of heparin, prepared by nitrous acid depolymerization of porcine mucosal heparin. The mean molecular weight is 4000-6000 daltons. It is used therapeutically as an antithrombotic agent. (From Merck Index, 11th ed)
Excerpt | Relevance | Reference |
---|---|---|
"In this double-blind, double-dummy, placebo-controlled trial, we randomly assigned acutely ill patients who had congestive heart failure or respiratory failure or other medical disorders and at least one additional risk factor for venous thromboembolism and who were hospitalized with an expected stay of at least 3 days to receive apixaban, administered orally at a dose of 2." | 5.15 | Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. ( Goldhaber, SZ; Haas, SK; Kakkar, AK; Knabb, RM; Leizorovicz, A; Merli, G; Weitz, JI, 2011) |
"Non-steroidal anti-inflammatory drugs (NSAIDs) may be prothrombotic, may worsen hypertension or congestive heart failure and obstruct access to the binding site of aspirin to cyclooxygenase-1 and thereby interfere with aspirin's mechanism of action in reducing death and recurrent myocardial infarction (MI)." | 3.75 | Association of non-steroidal anti-inflammatory drugs with outcomes in patients with ST-segment elevation myocardial infarction treated with fibrinolytic therapy: an ExTRACT-TIMI 25 analysis. ( Antman, EM; Aylward, PE; Bergovec, M; Buros, JL; Col, JJ; Gibson, CM; Goodman, SG; Gulba, D; Kunadian, V; Murphy, SA; Pride, YB; Zorkun, C, 2009) |
"Therapy to prevent deep venous thrombosis (DVT) and pulmonary embolism remains essential for inpatients, despite short periods of bedrest and hospitalization." | 2.41 | Deep venous thrombosis prophylaxis in patients with heart disease. ( Shively, BK, 2001) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 2 (6.67) | 18.2507 |
2000's | 12 (40.00) | 29.6817 |
2010's | 15 (50.00) | 24.3611 |
2020's | 1 (3.33) | 2.80 |
Authors | Studies |
---|---|
Sandner, SE | 1 |
Zimpfer, D | 1 |
Zrunek, P | 1 |
Steinlechner, B | 1 |
Rajek, A | 1 |
Schima, H | 1 |
Wolner, E | 1 |
Wieselthaler, GM | 1 |
De Lorenzo, F | 1 |
Newberry, D | 1 |
Scully, M | 1 |
Kadziola, Z | 1 |
Dawson, G | 1 |
Ranlall, N | 1 |
Saba, N | 1 |
Noorani, A | 1 |
Kashani, S | 1 |
Williams, R | 1 |
Kakkar, VV | 1 |
Shah, Z | 1 |
Mastoris, I | 1 |
Acharya, P | 1 |
Rali, AS | 1 |
Mohammed, M | 1 |
Sami, F | 1 |
Ranka, S | 1 |
Wagner, S | 1 |
Zanotti, G | 1 |
Salerno, CT | 1 |
Haglund, NA | 1 |
Sauer, AJ | 1 |
Ravichandran, AK | 1 |
Abicht, T | 1 |
Shavadia, J | 1 |
Welsh, R | 1 |
Gershlick, A | 1 |
Zheng, Y | 1 |
Huber, K | 2 |
Halvorsen, S | 2 |
Steg, PG | 1 |
Van de Werf, F | 2 |
Armstrong, PW | 2 |
Chi, G | 1 |
Januzzi, JL | 1 |
Korjian, S | 1 |
Daaboul, Y | 1 |
Goldhaber, SZ | 3 |
Hernandez, AF | 1 |
Hull, RD | 1 |
Gold, A | 1 |
Cohen, AT | 5 |
Harrington, RA | 1 |
Gibson, CM | 2 |
Gershlick, AH | 1 |
Goldstein, P | 1 |
Wilcox, R | 1 |
Danays, T | 1 |
Lambert, Y | 1 |
Sulimov, V | 1 |
Rosell Ortiz, F | 1 |
Ostojic, M | 1 |
Welsh, RC | 1 |
Carvalho, AC | 1 |
Nanas, J | 1 |
Arntz, HR | 1 |
Grajek, S | 1 |
Fresco, C | 1 |
Bluhmki, E | 1 |
Regelin, A | 1 |
Vandenberghe, K | 1 |
Bogaerts, K | 1 |
Shantsila, E | 1 |
Lip, GY | 1 |
Mebazaa, A | 1 |
Spiro, TE | 1 |
Büller, HR | 1 |
Haskell, L | 1 |
Hu, D | 1 |
Hull, R | 1 |
Merli, G | 2 |
Schellong, SW | 1 |
Spyropoulos, AC | 1 |
Tapson, VF | 1 |
De Sanctis, Y | 1 |
Connors, JM | 1 |
Borden, M | 1 |
Kiernan, MS | 1 |
Pham, DT | 1 |
DeNofrio, D | 1 |
Sylvia, L | 1 |
Pride, YB | 1 |
Aylward, PE | 1 |
Col, JJ | 1 |
Goodman, SG | 1 |
Gulba, D | 1 |
Bergovec, M | 1 |
Kunadian, V | 1 |
Zorkun, C | 1 |
Buros, JL | 1 |
Murphy, SA | 2 |
Antman, EM | 2 |
Gheorghiade, M | 1 |
Thyssen, A | 1 |
Zolynas, R | 1 |
Nadar, VK | 1 |
Greenberg, BH | 1 |
Mehra, M | 1 |
Sun, X | 1 |
Tian, H | 1 |
Plotnikov, AN | 1 |
Burton, P | 1 |
Hammerstingl, C | 1 |
Omran, H | 1 |
Leizorovicz, A | 3 |
Kakkar, AK | 2 |
Haas, SK | 1 |
Knabb, RM | 1 |
Weitz, JI | 1 |
Cimminiello, C | 1 |
Parakh, R | 1 |
Wang, C | 1 |
Bergmann, JF | 1 |
Aispuru, GR | 1 |
Clavier, MM | 1 |
Cardone, AJ | 1 |
Gilberto, DO | 1 |
Barousse, AP | 1 |
Kleber, FX | 1 |
Witt, C | 1 |
Vogel, G | 1 |
Koppenhagen, K | 1 |
Schomaker, U | 1 |
Flosbach, CW | 1 |
Alikhan, R | 2 |
Combe, S | 2 |
Samama, MM | 2 |
Desjardins, L | 2 |
Eldor, A | 2 |
Janbon, C | 2 |
Olsson, CG | 2 |
Turpie, AG | 2 |
Shimpo, M | 1 |
Morrow, DA | 1 |
Weinberg, EO | 1 |
Sabatine, MS | 1 |
Lee, RT | 1 |
Ol'binskaia, LI | 1 |
Kolosova, KIu | 1 |
Nesterova, SG | 1 |
Egorova, TD | 1 |
Fedorova, AIu | 1 |
Kirsch, M | 1 |
Vermes, E | 1 |
Boval, B | 1 |
Drouet, L | 1 |
Loisance, D | 1 |
Prifti, E | 1 |
Bonacchi, M | 1 |
Leacche, M | 1 |
Miraldi, F | 1 |
Shively, BK | 1 |
Tebbe, U | 1 |
Schellong, SM | 1 |
Haas, S | 1 |
Gerlach, HE | 1 |
Abletshauser, C | 1 |
Sieder, C | 1 |
Bramlage, P | 1 |
Riess, H | 1 |
Haines, ST | 1 |
Dager, WE | 1 |
Trujillo, TC | 1 |
Ferguson, JJ | 1 |
Kakkar, R | 1 |
Ellis, M | 1 |
Fearon, PV | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
STREAM (Strategic Reperfusion Early After Myocardial Infarction). Comparison of the Efficacy and Safety of a Strategy of Early Fibrinolytic Treatment With Tenecteplase and Additional Antiplatelet and Antithrombin Therapy Followed by Catheterisation Within[NCT00623623] | Phase 3 | 1,899 participants (Actual) | Interventional | 2008-03-01 | Completed | ||
(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients[NCT01583218] | Phase 3 | 7,513 participants (Actual) | Interventional | 2012-03-31 | Completed | ||
STrategic Reperfusion in Elderly Patients Early After Myocardial Infarction[NCT02777580] | Phase 4 | 609 participants (Actual) | Interventional | 2017-08-01 | Active, not recruiting | ||
Dapagliflozin Effects on Mayor Adverse Cardiovascular Events in Patients With Acute Myocardial Infarction (DAPA-AMI). Randomized Clinical Trial[NCT04717986] | 188 participants (Actual) | Interventional | 2021-01-26 | Completed | |||
Reperfusion Strategies in ST Elevation Myocardial Infarction Network - Sao Paulo Registry.[NCT02090712] | 3,000 participants (Anticipated) | Observational [Patient Registry] | 2010-01-31 | Enrolling by invitation | |||
Diagnostic and Prognostic Value of Cardiac Biomarkers and Echocardiography for Patients Hospitalized Due to Acute Dyspnea: Prospective Observational Multicenter Cohort Study[NCT03048032] | 1,566 participants (Actual) | Observational | 2015-04-30 | Completed | |||
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 3 | 8,101 participants (Actual) | Interventional | 2007-12-31 | Completed | ||
Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome[NCT04420312] | 1,024 participants (Actual) | Observational | 2020-03-01 | Completed | |||
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.[NCT00457002] | Phase 3 | 6,758 participants (Actual) | Interventional | 2007-06-30 | Completed | ||
Evaluation of the Use of an Oral Direct Anti-Xa Anticoagulant, Apixaban, in Prevention of Venous Thromboembolic Disease in Patients Treated With IMiDs During Myeloma : a Pilot Study[NCT02066454] | Phase 3 | 105 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting | ||
International, Multi-center, Randomized, Double Blind Study to Compare the Overall Mortality in Acutely Ill Medical Patients Treated With Enoxaparin Versus Placebo in Addition to Graduated Elastic Stockings[NCT00622648] | Phase 4 | 8,329 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
Title: EHR Embedded Risk Calculator vs. Standard VTE Prophylaxis for Medical Patients[NCT03243708] | 90,537 participants (Actual) | Interventional | 2017-12-04 | Completed | |||
A Randomized, Double-blind, Multi-center Comparison of the Efficacy and Safety of Certoparin (3000 U Anti-Xa o.d.) With Unfractionated Heparin (5000 IU t.i.d.) in the Prophylaxis of Thromboembolic Events in Acutely Ill Medical Patients[NCT00451412] | Phase 3 | 3,254 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
This is a key secondary endpoint. The number of observed patients with all cause death and non-fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 50 |
Primary PCI (Group B) | 43 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 59 |
Primary PCI (Group B) | 73 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF within 30 days was reported. (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 100 |
Primary PCI (Group B) | 123 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock and CHF and reinfarction and disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 117 |
Primary PCI (Group B) | 135 |
This is a key secondary endpoint. The number of observed patients with all cause death and shock and reinfarction within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 77 |
Primary PCI (Group B) | 85 |
This is a key secondary endpoint. The number of observed patients with all cause mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 43 |
Primary PCI (Group B) | 42 |
The number of observed patients with all-cause mortality, cardiogenic shock, congestive heart failure (CHF) and recurrent myocardial infarction within 30 days was reported for full analysis set (FAS). (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 116 |
Primary PCI (Group B) | 135 |
This is a key secondary endpoint. The number of observed patients with cardiac mortality within 30 days was reported. (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 31 |
Primary PCI (Group B) | 32 |
This is a key secondary endpoint. The number of observed patients with cardiogenic shock within 30 days was reported. (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 41 |
Primary PCI (Group B) | 56 |
This is a key secondary endpoint. The number of observed patients with congestive heart failure (CHF) within 30 days was reported. (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 57 |
Primary PCI (Group B) | 72 |
This is a key secondary endpoint. The number of observed patients with intracranial haemorrhage within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 9 |
Primary PCI (Group B) | 2 |
This is a key secondary endpoint. The number of observed patients with ischaemic stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 6 |
Primary PCI (Group B) | 3 |
This is a key secondary endpoint. The number of observed patients with major non-intracranial bleeds including blood transfusions within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 61 |
Primary PCI (Group B) | 45 |
This is a key secondary endpoint. The number of observed patients with minor non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 206 |
Primary PCI (Group B) | 191 |
This is a key secondary endpoint. The number of observed patients with recurrent myocardial infarction (reinfarction) within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 23 |
Primary PCI (Group B) | 21 |
This is a key secondary endpoint. The number of observed patients with rehospitalisation for cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 45 |
Primary PCI (Group B) | 41 |
This is a key secondary endpoint. The number of observed patients with rehospitalisation for non-cardiac reasons within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 19 |
Primary PCI (Group B) | 11 |
This is a key secondary endpoint. The number of observed patients with serious repeat target vessel revascularization within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 1 |
Primary PCI (Group B) | 2 |
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 32 |
Primary PCI (Group B) | 38 |
This is a key secondary endpoint. The number of observed patients with serious resuscitated ventricular fibrillation in association with invasive procedures (occurring at any time during catheterisation or urgent/elective PCI) within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 10 |
Primary PCI (Group B) | 29 |
This is a key secondary endpoint. The number of observed patients with total disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 2 |
Primary PCI (Group B) | 0 |
This is a key secondary endpoint. The number of observed patients with total fatal stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 7 |
Primary PCI (Group B) | 4 |
This is a key secondary endpoint. The number of observed patients with total non-disabling stroke within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 8 |
Primary PCI (Group B) | 1 |
This is a key secondary endpoint. The number of observed patients with total non-intracranial bleeds within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 267 |
Primary PCI (Group B) | 236 |
This is a key secondary endpoint. The number of observed patients with total stroke (all types) within 30 days was reported (NCT00623623)
Timeframe: 30 days
Intervention | Participants (Count of Participants) |
---|---|
Tenecteplase (Group A) | 15 |
Primary PCI (Group B) | 5 |
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 1: Between randomization and Day 42 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 1.30 |
Enoxaparin | 1.90 |
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 2: Between randomization and Day 42 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 1.03 |
Enoxaparin | 1.45 |
mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 2: Between randomization and Day 47 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 4.70 |
Enoxaparin | 6.02 |
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT: Between randomization and Day 42 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 0.94 |
Enoxaparin | 1.45 |
mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT: Between randomization and Day 47 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 4.43 |
Enoxaparin | 5.99 |
mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1). (NCT01583218)
Timeframe: mITT Cohort 1: Between randomization and Day 47 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 5.70 |
Enoxaparin | 7.18 |
Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication. (NCT01583218)
Timeframe: Between randomization and Day 49 (max)
Intervention | Percentage of Participants (Number) |
---|---|
Betrixaban | 0.67 |
Enoxaparin | 0.57 |
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 VTE-related death. (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.4 |
Enoxaparin | 5.7 |
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
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 8.6 |
Enoxaparin | 9.2 |
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 VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 2.7 |
Enoxaparin | 2.7 |
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 VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 3.0 |
Enoxaparin | 3.1 |
Net clinical benefit is a composite of the primary efficacy endpoint (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 VTE-related death) plus major and clinically relevant non-major bleeding events (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.5 |
Enoxaparin | 3.9 |
Net clinical benefit is a composite of the primary efficacy endpoint (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 VTE-related death) plus major and clinically relevant non-major bleeding events. (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 9.4 |
Enoxaparin | 7.8 |
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
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 2.8 |
Enoxaparin | 1.2 |
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
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.1 |
Enoxaparin | 1.7 |
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
Intervention | Percentage of participants (Number) |
---|---|
Rivaroxaban (Xarelto, BAY59-7939) | 4.8 |
Enoxaparin | 4.5 |
All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths. (NCT00571649)
Timeframe: Up to Day 90 + 7 days
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Any event | Death (cardiovascular) | Death (other) | VTE related death | |
Enoxaparin | 6.2 | 1.4 | 3.7 | 1.1 |
Rivaroxaban (Xarelto, BAY59-7939) | 6.7 | 1.4 | 4.3 | 1.0 |
The components of the composite endpoint include 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 VTE-related death. (NCT00571649)
Timeframe: Up to Day 10 + 5 days
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Symptomatic non-fatal PE | Symptomatic DVT in lower extremity | Asymptomatic proximal DVT in lower extremity | VTE related death | |
Enoxaparin | 0.1 | 0.2 | 2.4 | 0.2 |
Rivaroxaban (Xarelto, BAY59-7939) | 0.2 | 0.2 | 2.4 | 0.1 |
The components of the composite endpoint include 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 VTE-related death. (NCT00571649)
Timeframe: Up to Day 35 + 6 days
Intervention | Percentage of participants (Number) | |||
---|---|---|---|---|
Symptomatic non-fatal PE | Symptomatic DVT in lower extremity | Asymptomatic proximal DVT in lower extremity | VTE related death | |
Enoxaparin | 0.5 | 0.5 | 4.4 | 1.0 |
Rivaroxaban (Xarelto, BAY59-7939) | 0.3 | 0.4 | 3.5 | 0.6 |
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
Intervention | Percentage of participants (Number) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Any event-Day 10 | Ischemic stroke-Day 10 | Acute MI-Day 10 | Death (cardiovascular)-Day 10 | Any event-Day 35 | Ischemic stroke-Day 35 | Acute MI-Day 35 | Death (cardiovascular)-Day 35 | Any event-Day 90 | Ischemic stroke-Day 90 | Acute MI-Day 90 | Death (cardiovascular)-Day 90 | |
Enoxaparin | 1.0 | 0.3 | 0.4 | 0.4 | 1.6 | 0.5 | 0.5 | 0.8 | 2.8 | 1.1 | 0.7 | 1.4 |
Rivaroxaban (Xarelto, BAY59-7939) | 1.0 | 0.3 | 0.5 | 0.4 | 1.8 | 0.5 | 0.6 | 0.9 | 2.8 | 0.8 | 0.9 | 1.4 |
Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90 (NCT00571649)
Timeframe: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Intervention | Percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
symptomatic VTE (incl. VTE-related death)-Day 10 | symptomatic VTE (non fatal)-Day 10 | symptomatic VTE (incl. VTE-related death)-Day 35 | symptomatic VTE (non fatal)-Day 35 | symptomatic VTE (incl. VTE-related death)-Day 90 | symptomatic VTE (non fatal)-Day 90 | |
Enoxaparin | 0.6 | 0.3 | 1.4 | 0.7 | 1.9 | 0.9 |
Rivaroxaban (Xarelto, BAY59-7939) | 0.7 | 0.5 | 1.0 | 0.6 | 1.7 | 0.7 |
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 2.36 |
Enoxaparin 40 mg | 2.12 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.22 |
Enoxaparin 40 mg | 0.24 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.22 |
Enoxaparin 40 mg | 0.24 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 2.40 |
Enoxaparin 40 mg | 2.50 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 6.44 |
Enoxaparin 40 mg | 6.50 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 2.71 |
Enoxaparin 40 mg | 2.93 |
Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.00 |
Enoxaparin 40 mg | 0.15 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.15 |
Enoxaparin 40 mg | 0.49 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.15 |
Enoxaparin 40 mg | 0.37 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 3.11 |
Enoxaparin 40 mg | 3.46 |
Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1 to last dose of parenteral study drug plus 1 day
Intervention | Event rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 1.73 |
Enoxaparin 40 mg | 1.61 |
Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1 to last dose of parenteral study drug plus 1 day
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 1.66 |
Enoxaparin 40 mg | 1.51 |
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 6.44 |
Enoxaparin 40 mg | 6.63 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.06 |
Enoxaparin 40 mg | 0.09 |
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of drug to last dose of drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 7.73 |
Enoxaparin 40 mg | 6.81 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 7.16 |
Enoxaparin 40 mg | 6.83 |
Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Intervention | Event Rate (%): (Number) |
---|---|
Apixaban 2.5 mg | 2.26 |
Enoxaparin 40 mg | 1.90 |
VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 2.71 |
Enoxaparin 40 mg | 3.06 |
Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 2.67 |
Enoxaparin 40 mg | 2.08 |
Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.47 |
Enoxaparin 40 mg | 0.19 |
Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). (NCT00457002)
Timeframe: Intended Treatment Period
Intervention | Event Rate (%) (Number) |
---|---|
Apixaban 2.5 mg | 0.40 |
Enoxaparin 40 mg | 0.80 |
Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | Event Rate (%) (Number) | |||
---|---|---|---|---|
MI or stoke (N=3183, 3216) | MI (N=3184, 3217) | Stroke (N=3183, 3216) | Thrombocytopenia (N=3184, 3217) | |
Apixaban 2.5 mg | 0.38 | 0.22 | 0.16 | 0.19 |
Enoxaparin 40 mg | 0.37 | 0.12 | 0.25 | 0.09 |
Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | mmHg (Mean) | |
---|---|---|
Day of Discharge from Hospital (N=1607, 1625) | Day 30 of Treatment + 2 (N=2227,2301) | |
Apixaban 2.5 mg | -1.0 | 0.0 |
Enoxaparin 40 mg | -0.4 | -0.5 |
Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | bpm (Mean) | |
---|---|---|
Hospital Discharge (N=1606,1622) | Day 30 of treatment (N=2225,2299) | |
Apixaban 2.5 mg | -5.4 | -4.0 |
Enoxaparin 40 mg | -5.1 | -4.3 |
Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | mmHg (Mean) | |
---|---|---|
Discharge from Hospital (N=1607, 1625) | Day 30 of Treatment + 2 (N=2227, 2301) | |
Apixaban 2.5 mg | -3.0 | -2.3 |
Enoxaparin 40 mg | -2.4 | -2.9 |
Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths. (NCT00457002)
Timeframe: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
Intervention | participants (Number) | ||||
---|---|---|---|---|---|
AEs | SAEs | Bleeding AEs | Discontinuations Due to AE | Deaths | |
Apixaban 2.5 mg | 1871 | 611 | 244 | 290 | 131 |
Enoxaparin 40 mg | 1910 | 601 | 221 | 262 | 133 |
Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
Intervention | participants (Number) | |||
---|---|---|---|---|
Neurologic AEs | Neurologic SAEs | Liver-related AEs | Liver-related SAEs | |
Apixaban 2.5 mg | 45 | 5 | 127 | 9 |
Enoxaparin 40 mg | 42 | 1 | 142 | 12 |
Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) | |||||
---|---|---|---|---|---|---|
AST Elevation >3*ULN (N=2831, 2863) | ALT Elevation >3*ULN (N=2827, 2861) | AST + ALT >3*ULN on same date (N= 2827, 2861) | TBili >2*ULN (N= 2853, 2884) | ALT or AST >3*ULN + TBili >2*ULN (N=2818,2855) | ALT>3*ULN + TBili >2*ULN (N=2817, 2853) | |
Apixaban 2.5 mg | 23 | 22 | 14 | 13 | 2 | 0 |
Enoxaparin 40 mg | 28 | 32 | 13 | 14 | 2 | 2 |
Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Calcium < 0.8*LLN (N=2861, 2893) | Calcium > 1.2*ULN (N=2861, 2893) | Chloride < 0.9*LLN (N=2861, 2886) | Chloride > 1.1*ULN (N=2861, 2886) | Bicarbonate < 0.75*LLN (N=2831, 2855) | Bicarbonate > 1.25*ULN (N=2831, 2855) | Potassium < 0.9*LLN (N=2851, 2878) | Potassium > 1.1*ULN (N=2851, 2878) | Sodium < 0.95*LLN (N=2862, 2888) | Sodium > 1.05*ULN (N=2862, 2888) | |
Apixaban 2.5 mg | 6 | 3 | 25 | 5 | 5 | 6 | 61 | 140 | 23 | 9 |
Enoxaparin 40 mg | 8 | 3 | 25 | 1 | 6 | 4 | 58 | 137 | 25 | 6 |
Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) | |||||
---|---|---|---|---|---|---|
Glucose Fasting <0.9*LLN (N=284,287) | Glucose Fasting > 1.5*ULN (N=284,287) | Total Protein < 0.9 *LLN (N=2864, 2890) | Total Protein > 1.1*ULN (N=2864, 2890) | Creatine kinase >5*ULN U/L(N=2856, 2888) | Uric acid > 1.5* ULN (N=2862, 2889) | |
Apixaban 2.5 mg | 5 | 39 | 78 | 16 | 8 | 47 |
Enoxaparin 40 mg | 3 | 30 | 51 | 8 | 10 | 44 |
Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Hemoglobin >2 g/dL decrease (N=2835, 2871) | Hematocrit <0.75*PreRx (N=2688, 2722) | Platelet Count < 100*10^9 c/L (N=2761, 2799) | Erythrocytes <0.75*PreRx c/µL (N=2697, 2730) | Leukocytes <0.75*LLN (N= 2835, 2869) | Leukocytes > 1.25*ULN (N=2835, 2869) | Abs Eosinophils > 0.75*10^3 c/µL (N=20, 24) | Abs Lymphocytes < 0.750*10*3 c/ µL (N=20, 24) | Abs Monocytes > 2000/MM^3 (N= 19, 25) | |
Apixaban 2.5 mg | 133 | 23 | 9 | 28 | 64 | 331 | 1 | 4 | 1 |
Enoxaparin 40 mg | 98 | 17 | 7 | 16 | 55 | 283 | 1 | 2 | 0 |
Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. (NCT00457002)
Timeframe: Day 1 to last dose of study drug plus 2 days
Intervention | participants (Number) | ||||||
---|---|---|---|---|---|---|---|
Alkaline phosphatase U/L > 2*ULN(N=2866, 2895) | ALT U/L > 3*ULN (N=2827, 2861) | AST U/L > 3*ULN (N=2831, 2863) | Bilirubin Direct mg/dL > 1.5*ULN (N=2782, 2821) | Bilirubin Total mg/dL > 2*ULN (N=2853, 2884) | BUN mg/dL > 1.5*ULN (N=2864, 2891) | Creatinine mg/dL > 1.5*ULN (N=2862, 2892) | |
Apixaban 2.5 mg | 35 | 23 | 24 | 123 | 17 | 194 | 150 |
Enoxaparin 40 mg | 47 | 33 | 29 | 106 | 15 | 188 | 156 |
3 reviews available for dalteparin and Cardiac Failure
Article | Year |
---|---|
Discoveries in thrombosis care for medical patients.
Topics: Clinical Trials as Topic; Cost-Benefit Analysis; Critical Care; Drug Costs; Enoxaparin; Fibrinolytic | 2002 |
[Novel possibilities of antithrombotic therapy in patients with chronic heart failure].
Topics: Anticoagulants; Azetidines; Benzylamines; Dalteparin; Double-Blind Method; Enoxaparin; Fibrinolytic | 2005 |
Deep venous thrombosis prophylaxis in patients with heart disease.
Topics: Angina, Unstable; Anticoagulants; Critical Care; Enoxaparin; Heart Failure; Heparin; Humans; Myocard | 2001 |
11 trials available for dalteparin and Cardiac Failure
Article | Year |
---|---|
Low molecular weight heparin as an alternative to unfractionated heparin in the immediate postoperative period after left ventricular assist device implantation.
Topics: Aged; Anticoagulants; Aspirin; Dipyridamole; Heart Failure; Heart-Assist Devices; Heparin; Heparin, | 2008 |
Low molecular weight heparin (bemiparin sodium) and the coagulation profile of patients with heart failure.
Topics: Aged; Aged, 80 and over; Biomarkers; Blood Coagulation Disorders; Double-Blind Method; Factor VII; F | 2002 |
N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy.
Topics: Acute Disease; Aged; Aged, 80 and over; Benzamides; Enoxaparin; Female; Heart Failure; Hospitalizati | 2017 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Fibrinolysis or primary PCI in ST-segment elevation myocardial infarction.
Topics: Aged; Angioplasty, Balloon, Coronary; Clopidogrel; Coronary Angiography; Drug Therapy, Combination; | 2013 |
Predicting the risk of venous thromboembolism in patients hospitalized with heart failure.
Topics: Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Fema | 2014 |
Predicting the risk of venous thromboembolism in patients hospitalized with heart failure.
Topics: Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Fema | 2014 |
Predicting the risk of venous thromboembolism in patients hospitalized with heart failure.
Topics: Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Fema | 2014 |
Predicting the risk of venous thromboembolism in patients hospitalized with heart failure.
Topics: Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Enoxaparin; Factor Xa Inhibitors; Fema | 2014 |
Pharmacokinetics and pharmacodynamics of rivaroxaban and its effect on biomarkers of hypercoagulability in patients with chronic heart failure.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Antithrombin III; Biomarkers; Chronic Disease; Doubl | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients.
Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Anticoagulants; Double-Blind Method; Drug Administrat | 2011 |
Low-molecular-weight heparin and mortality in acutely ill medical patients.
Topics: Acute Disease; Aged; Anticoagulants; Cause of Death; Combined Modality Therapy; Double-Blind Method; | 2011 |
Low-molecular-weight heparin and mortality in acutely ill medical patients.
Topics: Acute Disease; Aged; Anticoagulants; Cause of Death; Combined Modality Therapy; Double-Blind Method; | 2011 |
Low-molecular-weight heparin and mortality in acutely ill medical patients.
Topics: Acute Disease; Aged; Anticoagulants; Cause of Death; Combined Modality Therapy; Double-Blind Method; | 2011 |
Low-molecular-weight heparin and mortality in acutely ill medical patients.
Topics: Acute Disease; Aged; Anticoagulants; Cause of Death; Combined Modality Therapy; Double-Blind Method; | 2011 |
Randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease.
Topics: Aged; Anticoagulants; Drug Administration Schedule; Enoxaparin; Female; Heart Failure; Hemorrhage; H | 2003 |
Prevention of venous thromboembolism in medical patients with enoxaparin: a subgroup analysis of the MEDENOX study.
Topics: Aged; Aged, 80 and over; Anticoagulants; Chronic Disease; Dose-Response Relationship, Drug; Double-B | 2003 |
Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study.
Topics: Aged; Anticoagulants; Double-Blind Method; Female; Heart Failure; Heparin; Heparin, Low-Molecular-We | 2011 |
16 other studies available for dalteparin and Cardiac Failure
Article | Year |
---|---|
The use of enoxaparin as bridge to therapeutic INR after LVAD implantation.
Topics: Anticoagulants; Drug Administration Schedule; Enoxaparin; Female; Heart Failure; Heart-Assist Device | 2020 |
Relationship Between Arterial Access and Outcomes in ST-Elevation Myocardial Infarction With a Pharmacoinvasive Versus Primary Percutaneous Coronary Intervention Strategy: Insights From the STrategic Reperfusion Early After Myocardial Infarction (STREAM)
Topics: Aged; Aspirin; Catheterization, Peripheral; Clopidogrel; Coronary Angiography; Enoxaparin; Female; F | 2016 |
Thrombotic complications in heart failure: an underappreciated challenge.
Topics: Enoxaparin; Female; Heart Failure; Humans; Male; Morpholines; Rivaroxaban; Thiophenes; Venous Thromb | 2014 |
Anticoagulation management of left ventricular assist devices.
Topics: Anticoagulants; Aspirin; Enoxaparin; Female; Heart Failure; Heart Transplantation; Heart Ventricles; | 2015 |
Bridging with half-therapeutic dose enoxaparin in outpatients with left ventricular assist devices and sub-therapeutic international normalized ratios.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Dose-Response Relationship, Drug; Enoxaparin; Feasib | 2015 |
Association of non-steroidal anti-inflammatory drugs with outcomes in patients with ST-segment elevation myocardial infarction treated with fibrinolytic therapy: an ExTRACT-TIMI 25 analysis.
Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Anticoagulants; Aspirin; Combined Modality Therapy; C | 2009 |
Perioperative bridging of chronic oral anticoagulation in patients undergoing pacemaker implantation--a study in 200 patients.
Topics: Aged; Aged, 80 and over; Anticoagulants; Cardiac Surgical Procedures; Enoxaparin; Female; Heart Fail | 2011 |
Thrombotic biomarkers and left ventricle characteristics as short-term predictors of thrombotic events in patients hospitalized for acute decompensated heart failure.
Topics: Aged; Aged, 80 and over; Anticoagulants; Biomarkers; Echocardiography; Enoxaparin; Female; Fibrin Fi | 2012 |
Serum levels of the interleukin-1 receptor family member ST2 predict mortality and clinical outcome in acute myocardial infarction.
Topics: Abciximab; Aged; Antibodies, Monoclonal; Anticoagulants; Clinical Trials as Topic; Comorbidity; Drug | 2004 |
Risk factors for venous thromboembolism in hospitalized patients with acute medical illness: analysis of the MEDENOX Study.
Topics: Acute Disease; Aged; Anticoagulants; Comorbidity; Enoxaparin; Female; Heart Failure; Hospitalization | 2004 |
[Four years of circulatory support with the INCOR axial pump from Berlin Heart].
Topics: Clopidogrel; Coronary Thrombosis; Enoxaparin; Fibrinolytic Agents; Heart Failure; Heart-Assist Devic | 2007 |
[Prevention of embolism in severely ill internal medicine patients. In heart failure it is better to use low molecular weight heparin].
Topics: Anticoagulants; Clinical Trials as Topic; Enoxaparin; Germany; Heart Failure; Humans; Thromboembolis | 1999 |
Undergoing cardiopulmonary bypass using enoxaparin only during a cardiac transplantation procedure.
Topics: Adult; Anticoagulants; Blood Loss, Surgical; Blood Transfusion; Cardiac Catheterization; Cardiopulmo | 2000 |
Clinical and management challenges in preventing venous thromboembolism in health systems: a case-based panel discussion.
Topics: Aged; Anticoagulants; Arthroplasty, Replacement, Hip; Bariatric Surgery; Colonic Neoplasms; Daltepar | 2010 |
Meeting highlights. Highlights of the 48th scientific sessions of the American College of Cardiology.
Topics: Abciximab; Alanine; Angioplasty, Balloon, Coronary; Angiotensin-Converting Enzyme Inhibitors; Antibo | 1999 |
Compartment syndrome of the thigh as a complication of anticoagulant therapy in a patient with a left ventricular assist device (Berlin Heart).
Topics: Anticoagulants; Compartment Syndromes; Heart Failure; Heart-Assist Devices; Hemorrhage; Heparin, Low | 2010 |