beta-alanine has been researched along with Recrudescence in 14 studies
| Excerpt | Relevance | Reference |
|---|---|---|
| "Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE." | 9.19 | Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. ( Christiansen, AV; Eriksson, H; Friedman, J; Goldhaber, SZ; Kakkar, AK; Kearon, C; Le Maulf, F; Mismetti, P; Peter, N; Schellong, S; Schulman, S, 2014) |
| "Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo." | 9.17 | Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. ( Baanstra, D; Eriksson, H; Friedman, J; Goldhaber, SZ; Kakkar, AK; Kearon, C; Kvamme, AM; Mismetti, P; Schellong, S; Schulman, S, 2013) |
| "After an acute coronary syndrome, patients remain at risk of recurrent ischaemic events, despite contemporary treatment, including aspirin and clopidogrel." | 9.15 | Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. ( Budaj, A; Granger, CB; Khder, Y; Oldgren, J; Roberts, J; Siegbahn, A; Tijssen, JG; Van de Werf, F; Wallentin, L, 2011) |
| "A 70-year-old man with multiple ischemic strokes was diagnosed with cardiac embolism and treated with dabigatran." | 7.80 | Recurrent ischemic stroke in a patient with the Trousseau syndrome treated with dabigatran. ( Aburakawa, Y; Kimura, T; Kuroda, K; Suzuki, Y; Yahara, O; Yoshida, K, 2014) |
| " A second woman with primary APS experienced ischemic arterial strokes and right transverse-sigmoid sinus thrombosis after conversion to rivaroxaban." | 7.80 | Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: a case series of three patients. ( Black, DF; McBane, RD; Moder, KG; Schaefer, JK; Williams, LN; Wysokinski, WE, 2014) |
| "Dabigatran has similar effects on VTE recurrence and a lower risk of bleeding compared with warfarin for the treatment of acute VTE." | 5.19 | Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis. ( Christiansen, AV; Eriksson, H; Friedman, J; Goldhaber, SZ; Kakkar, AK; Kearon, C; Le Maulf, F; Mismetti, P; Peter, N; Schellong, S; Schulman, S, 2014) |
| "Dabigatran was effective in the extended treatment of venous thromboembolism and carried a lower risk of major or clinically relevant bleeding than warfarin but a higher risk than placebo." | 5.17 | Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. ( Baanstra, D; Eriksson, H; Friedman, J; Goldhaber, SZ; Kakkar, AK; Kearon, C; Kvamme, AM; Mismetti, P; Schellong, S; Schulman, S, 2013) |
| "After an acute coronary syndrome, patients remain at risk of recurrent ischaemic events, despite contemporary treatment, including aspirin and clopidogrel." | 5.15 | Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. ( Budaj, A; Granger, CB; Khder, Y; Oldgren, J; Roberts, J; Siegbahn, A; Tijssen, JG; Van de Werf, F; Wallentin, L, 2011) |
| "To summarise and compare the efficacy and safety of various oral anticoagulants (dabigatran, rivaroxaban, apixaban, and vitamin K antagonists) and antiplatelet agents (acetylsalicylic acid) for the secondary prevention of venous thromboembolism." | 4.89 | Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis. ( Cameron, C; Carrier, M; Castellucci, LA; Clifford, T; Coyle, D; Gandara, E; Le Gal, G; Rodger, MA; Wells, G; Wells, PS, 2013) |
| "A 70-year-old man with multiple ischemic strokes was diagnosed with cardiac embolism and treated with dabigatran." | 3.80 | Recurrent ischemic stroke in a patient with the Trousseau syndrome treated with dabigatran. ( Aburakawa, Y; Kimura, T; Kuroda, K; Suzuki, Y; Yahara, O; Yoshida, K, 2014) |
| " A second woman with primary APS experienced ischemic arterial strokes and right transverse-sigmoid sinus thrombosis after conversion to rivaroxaban." | 3.80 | Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: a case series of three patients. ( Black, DF; McBane, RD; Moder, KG; Schaefer, JK; Williams, LN; Wysokinski, WE, 2014) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 14 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Schulman, S | 2 |
| Kearon, C | 2 |
| Kakkar, AK | 2 |
| Schellong, S | 2 |
| Eriksson, H | 2 |
| Baanstra, D | 1 |
| Kvamme, AM | 1 |
| Friedman, J | 2 |
| Mismetti, P | 2 |
| Goldhaber, SZ | 2 |
| Castellucci, LA | 1 |
| Cameron, C | 1 |
| Le Gal, G | 1 |
| Rodger, MA | 1 |
| Coyle, D | 1 |
| Wells, PS | 1 |
| Clifford, T | 1 |
| Gandara, E | 1 |
| Wells, G | 1 |
| Carrier, M | 1 |
| Christiansen, AV | 1 |
| Le Maulf, F | 1 |
| Peter, N | 1 |
| Yoshida, K | 1 |
| Kimura, T | 1 |
| Aburakawa, Y | 1 |
| Suzuki, Y | 1 |
| Kuroda, K | 1 |
| Yahara, O | 1 |
| Alotaibi, G | 1 |
| Alsaleh, K | 1 |
| Wu, C | 1 |
| Mcmurtry, MS | 1 |
| Schaefer, JK | 1 |
| McBane, RD | 1 |
| Black, DF | 1 |
| Williams, LN | 1 |
| Moder, KG | 1 |
| Wysokinski, WE | 1 |
| Sengupta, N | 1 |
| Feuerstein, JD | 1 |
| Patwardhan, VR | 1 |
| Tapper, EB | 1 |
| Ketwaroo, GA | 1 |
| Thaker, AM | 1 |
| Leffler, DA | 1 |
| Chan, EW | 1 |
| Lau, WC | 1 |
| Leung, WK | 1 |
| Mok, MT | 1 |
| He, Y | 1 |
| Tong, TS | 1 |
| Wong, IC | 1 |
| Walti, C | 1 |
| Bächli, E | 1 |
| Michota, F | 1 |
| Oldgren, J | 1 |
| Budaj, A | 1 |
| Granger, CB | 1 |
| Khder, Y | 1 |
| Roberts, J | 1 |
| Siegbahn, A | 1 |
| Tijssen, JG | 1 |
| Van de Werf, F | 1 |
| Wallentin, L | 1 |
| Sawaya, FJ | 1 |
| Musallam, KM | 1 |
| Arnaout, S | 1 |
| Rabah, A | 1 |
| Sawaya, J | 1 |
| Thorne, KM | 1 |
| Dee, S | 1 |
| Jayathissa, S | 1 |
| Twig, G | 1 |
| Furer, A | 1 |
| Yaniv, G | 1 |
| Michael, L | 1 |
| Karplus, R | 1 |
| Amital, H | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Investigation of Genetic Variations on Patients With Adverse Events While on Direct Oral Anticoagulants (DOACs)[NCT04580589] | 210 participants (Actual) | Observational | 2021-02-01 | Completed | |||
| Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long-term Prevention of Recurrent Symptomatic Proximal Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism.[NCT00558259] | Phase 3 | 1,353 participants (Actual) | Interventional | 2007-11-30 | Completed | ||
| A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembo[NCT00329238] | Phase 3 | 2,867 participants (Actual) | Interventional | 2006-05-31 | Completed | ||
| The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis[NCT04981327] | Phase 3 | 1,300 participants (Anticipated) | Interventional | 2022-09-01 | Not yet recruiting | ||
| The Prevalence of Post-Thrombotic Syndrome in Deep-Vein Thrombosis (DVT) Patients Treated With Dabigatran- a Cross-Sectional Assessment of RE-COVER Study Patients[NCT03050138] | 351 participants (Actual) | Observational | 2016-04-30 | Completed | |||
| A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism, Following Initial Treatm[NCT00680186] | Phase 3 | 2,589 participants (Actual) | Interventional | 2008-04-30 | Completed | ||
| A Phase III, Randomised, Double Blind, Parallel-group Study of the Efficacy and Safety of Oral Dabigatran Etexilate 150 mg Twice Daily Compared to Warfarin (INR 2.0-3.0) for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism (VTE), Following In[NCT00291330] | Phase 3 | 2,564 participants (Actual) | Interventional | 2006-02-28 | Completed | ||
| CHoosing Triple or Double therApy in the Era of nOac for patientS Undergoing PCI: the CHAOS a Multicenter Study.[NCT03558295] | 1,000 participants (Anticipated) | Observational [Patient Registry] | 2018-05-01 | Recruiting | |||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
Cardiovascular events that occurred during the treatment period + 3 days were summarised by treatment groups. (NCT00558259)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|---|
| Dabigatran | 3 |
| Placebo | 2 |
Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described. (NCT00558259)
Timeframe: 6 months
| Intervention | Participants (Number) |
|---|---|
| Dabigatran | 1 |
| Placebo | 14 |
Number of the participants with centrally confirmed symptomatic recurrent deep venous thrombotic (DVT) events during the intended treatment period were described. (NCT00558259)
Timeframe: 6 months
| Intervention | Participants (Number) |
|---|---|
| Dabigatran | 2 |
| Placebo | 23 |
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event. (NCT00558259)
Timeframe: 6 months
| Intervention | Participants (Number) |
|---|---|
| Dabigatran | 3 |
| Placebo | 35 |
Symptomatic recurrent VTE is the composite of recurrent deep vein thrombosis (DVT) , fatal or non-fatal pulmonary embolism (PE). Whilst the endpoint is time to event, the measured values present the number of participant with event and the hazard ratio presents the time to event. (NCT00558259)
Timeframe: 6 months
| Intervention | Participants (Number) |
|---|---|
| Dabigatran | 3 |
| Placebo | 37 |
Number of participants with centrally confirmed unexplained deaths during the intended treatment period were described. (NCT00558259)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|---|
| Dabigatran | 0 |
| Placebo | 2 |
"Major bleeding events (MBE) had to fulfil at least 1 of the following criteria:~Fatal bleeding~Associated with a fall in haemoglobin of ≥2 g/dL~Led to the transfusion of ≥2 units packed cells or whole blood~Occurred in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal~Other clinically relevant bleeding was defined as overt bleeding not meeting the criteria for an MBE but associated with medical intervention, unscheduled contact with a physician, (temporary) cessation of study treatment, or associated with discomfort such as pain, or impairment of activities of daily life.~Examples of these bleedings were:~Bleeding that compromised haemodynamics~Bleeding that led to hospitalisation~Trivial bleeding events were defined as all other bleeding events that did not fulfil the criteria of MBEs or CRBEs.~All bleeding events include MBEs, CRBEs, and trivial bleeding events." (NCT00558259)
Timeframe: 6 months
| Intervention | participants (Number) | ||
|---|---|---|---|
| MBE | MBE or CRBE | All Bleeding | |
| Dabigatran | 2 | 36 | 72 |
| Placebo | 0 | 12 | 39 |
Number of participants with possible clinically significant abnormalities during the treatment period. (NCT00558259)
Timeframe: 6 months
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| AST increase (N=655, 629) | ALT increase (N=655, 629) | Alkaline phosphatase increase (N=658, 629) | Total bilirubin increase (N=658, 628) | |
| Dabigatran | 2 | 3 | 0 | 1 |
| Placebo | 2 | 5 | 0 | 1 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. (NCT00329238)
Timeframe: 18 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 36 | 1394 |
| Warfarin | 32 | 1394 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and all cause death. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. (NCT00329238)
Timeframe: 36 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 42 | 1388 |
| Warfarin | 36 | 1390 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE. (NCT00329238)
Timeframe: 18 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 22 | 1408 |
| Warfarin | 17 | 1409 |
Endpoint is a composite of recurrent Venous Thromboembolic Event (VTE) and death related to VTE. VTE was defined as the composite of symptomatic Deep Vein Thrombosis (DVT) of the leg and Pulmonary embolism (PE). All recurrent VTEs required objective verification by definitive diagnostic evaluation. In case of death, autopsy was an additional way to confirm VTE. (NCT00329238)
Timeframe: 36 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 26 | 1404 |
| Warfarin | 18 | 1408 |
Deaths of all causes at 18 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments. (NCT00329238)
Timeframe: 18 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 15 | 1415 |
| Warfarin | 16 | 1410 |
Deaths of all causes at 36 Months. All components of the primary efficacy endpoint and all deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death without knowledge of any individual treatment assignments. (NCT00329238)
Timeframe: 36 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 17 | 1413 |
| Warfarin | 19 | 1407 |
Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way. (NCT00329238)
Timeframe: 18 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 1 | 1429 |
| Warfarin | 1 | 1425 |
Deaths related to VTE (i.e. fatal PE) at 36 Months. Deaths related to VTE (i.e. fatal PE) at 18 Months. All deaths were centrally adjudicated by the Independent Central Adjudication Committee for VTE and death in a treatment-blinded way. (NCT00329238)
Timeframe: 36 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 1 | 1429 |
| Warfarin | 1 | 1425 |
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation. (NCT00329238)
Timeframe: 36 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 17 | 1413 |
| Warfarin | 13 | 1413 |
Symptomatic Deep vein thrombosis (DVT). All DVT events required objective verification through definitive diagnostic evaluation. (NCT00329238)
Timeframe: 18 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 15 | 1415 |
| Warfarin | 12 | 1414 |
Patients with LFT (liver function tests) increases of possible clinical significance during treatment. Increases of possible clinical significance were defined as: ≥3 x ULN (AST, ALT), ≥2 x ULN (AP), and ≥2 mg/dL (total bilirubin). Only patients with a baseline value which was not of possible clinical significance (or without any baseline value) could have a PCSA (Possible clinically significant abnormality). (NCT00329238)
Timeframe: 18 months + 30 days follow up
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| ALT increase | AST increase | Alkaline phosphatase | Total bilirubin | |
| Dabigatran | 26 | 23 | 9 | 9 |
| Warfarin | 30 | 23 | 14 | 8 |
"MBE (major bleeding event) if it fulfilled at least one of the following criteria~Fatal bleeding~Symptomatic bleeding in a critical area or organ.~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells.~Minor bleeding event was any bleeding that did not fulfil any of the criteria for MBEs~CRBE (clinically relevant bleeding event) if it is a minor bleeding events which fulfilled at least one of the following criteria~Spontaneous skin haematoma ≥25 cm2~Spontaneous nose bleed >5 min duration~Macroscopic haematuria, either spontaneous or, if associated with an intervention, lasting >24 h~Spontaneous rectal bleeding~Gingival bleeding >5 min~Bleeding leading to hospitalisation or requiring surgical treatment~Bleeding leading to a transfusion of <2 units of whole blood or red cells~Any other bleeding event considered clinically relevant by the investigator" (NCT00329238)
Timeframe: first intake of study drug until 6 days following last intake of study drug
| Intervention | participants (Number) | ||
|---|---|---|---|
| patients with MBE | patients with MBE and /or CRBE | patients with any bleeding event | |
| Dabigatran | 13 | 80 | 277 |
| Warfarin | 25 | 145 | 373 |
All suspected ACS occurring during the trial were to be recorded on the CRF and were to be centrally adjudicated by an independent ACS/AC in a treatment-blinded manner. (NCT00329238)
Timeframe: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination
| Intervention | participants (Number) | |
|---|---|---|
| During intake of study drug, N=1430 , N=1415 | After stopping study drug, N=1426, N=1400 | |
| Dabigatran | 12 | 1 |
| Warfarin | 2 | 5 |
Symptomatic pulmonary embolism (PE) at 18 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography. (NCT00329238)
Timeframe: 18 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 8 | 1422 |
| Warfarin | 5 | 1421 |
Symptomatic pulmonary embolism (PE) at 36 Months (fatal or non-fatal). All suspected PEs required confirmation by one of the following: ventilation-perfusion (V-Q) lung scan, pulmonary angiography, or spiral (helical) Computed tomography. (NCT00329238)
Timeframe: 36 months
| Intervention | Participants (Number) | |
|---|---|---|
| Number of participants with event | Number of participants with no event | |
| Dabigatran | 10 | 1420 |
| Warfarin | 5 | 1421 |
Frequency of patients with possible clinically significant abnormalities. (NCT00680186)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| AST increase | AST decrease | ALT increase | ALT decrease | Bilirubin increase | Bilirubin decrease | |
| Dabigatran 150 mg | 29 | 0 | 31 | 0 | 8 | 0 |
| Warfarin | 27 | 0 | 40 | 0 | 6 | 0 |
Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 25 | 29 |
| Warfarin | 25 | 26 |
VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events. (NCT00680186)
Timeframe: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224)
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 3 | 3 |
| Warfarin | 0 | 0 |
Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings. (NCT00680186)
Timeframe: From first intake of study drug to last contact date
| Intervention | participants (Number) | |
|---|---|---|
| During intake of study drug | After stopping study drug | |
| Dabigatran 150 mg | 3 | 2 |
| Warfarin | 0 | 1 |
"Major bleeding events (MBE) are defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) are defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00680186)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout
| Intervention | participants (Number) | ||
|---|---|---|---|
| MBE | MBE and/or CRBE | Any bleeding event | |
| Dabigatran 150 mg | 15 | 64 | 200 |
| Warfarin | 22 | 102 | 285 |
Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 25 | 28 |
| Warfarin | 17 | 17 |
Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 8 | 10 |
| Warfarin | 13 | 15 |
Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 7 | 9 |
| Warfarin | 13 | 15 |
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 30 | 34 |
| Warfarin | 28 | 30 |
VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00680186)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 51 | 57 |
| Warfarin | 48 | 51 |
Frequency of patients with possible clinically significant abnormalities. (NCT00291330)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| AST increase | AST decrease | ALT increase | ALT decrease | Bilirubin increase | Bilirubin decrease | |
| Dabigatran 150 mg | 21 | 0 | 26 | 0 | 7 | 0 |
| Warfarin | 22 | 0 | 38 | 0 | 13 | 0 |
Any deaths which occured from randomisation to end of post treatment period. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 21 | 25 |
| Warfarin | 21 | 25 |
"VTE - related deaths which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 1 | 1 |
| Warfarin | 3 | 3 |
"Any ACS occurring during the conduct of the study (centrally adjudicated as definite).~Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: From first intake of study drug to end of study conduct
| Intervention | participants (Number) | ||
|---|---|---|---|
| During intake of active study drug | After stopping active study drug | Before/without intake of active study drug | |
| Dabigatran 150 mg | 5 | 4 | 2 |
| Warfarin | 3 | 2 | 0 |
"Major bleeding events (MBE) were defined as~Fatal bleeding~Symptomatic bleeding in a critical area or organ~Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells~Clinically-relevant bleeding events (CRBE) was defined as~spontaneous skin hematoma >=25 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding (more than spotting on toilet paper)~gingival bleeding >5 min~leading to hospitalisation and / or requiring surgical treatment~leading to a transfusion of <2 units of whole blood or red cells~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00291330)
Timeframe: From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)
| Intervention | participants (Number) | ||
|---|---|---|---|
| Major bleeding events | MBE and/or CRBE | Any bleeding events | |
| Dabigatran 150 mg | 20 | 71 | 207 |
| Warfarin | 24 | 111 | 280 |
"Symptomatic DVT which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 16 | 17 |
| Warfarin | 18 | 22 |
"Symptomatic non-fatal PE which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 13 | 16 |
| Warfarin | 7 | 8 |
All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180)
| Intervention | Participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 30 | 34 |
| Warfarin | 27 | 32 |
"VTE or any death which occured from randomisation to end of post treatment period.~All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee." (NCT00291330)
Timeframe: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224.
| Intervention | Participants (Number) | |
|---|---|---|
| Participants with event (up to day 180) | Participants with event (up to end of ptp) | |
| Dabigatran 150 mg | 48 | 55 |
| Warfarin | 44 | 53 |
4 reviews available for beta-alanine and Recrudescence
| Article | Year |
|---|---|
Efficacy and safety outcomes of oral anticoagulants and antiplatelet drugs in the secondary prevention of venous thromboembolism: systematic review and network meta-analysis.
Topics: Anticoagulants; Aspirin; Benzimidazoles; beta-Alanine; Dabigatran; Hemorrhage; Humans; Morpholines; | 2013 |
Dabigatran, rivaroxaban and apixaban for extended venous thromboembolism treatment: network meta-analysis.
Topics: Administration, Oral; Anticoagulants; Benzimidazoles; beta-Alanine; Chi-Square Distribution; Dabigat | 2014 |
[Direct acting oral anticoagulants in venous thromboembolism].
Topics: Administration, Oral; Aged; Anticoagulants; Benzimidazoles; beta-Alanine; Clinical Trials as Topic; | 2015 |
Intracerebral hemorrhage: Pick your poison.
Topics: Anticoagulants; Benzimidazoles; beta-Alanine; Cerebral Hemorrhage; Chronic Disease; Dabigatran; Huma | 2010 |
3 trials available for beta-alanine and Recrudescence
| Article | Year |
|---|---|
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Benzimidazoles; beta-Alanine; Dabigatran; Female; Follow | 2013 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Treatment of acute venous thromboembolism with dabigatran or warfarin and pooled analysis.
Topics: Acute Disease; Adolescent; Adult; Aged; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; | 2014 |
Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial.
Topics: Acute Coronary Syndrome; Aged; Aspirin; Benzimidazoles; beta-Alanine; Clopidogrel; Dabigatran; Dose- | 2011 |
7 other studies available for beta-alanine and Recrudescence
| Article | Year |
|---|---|
Recurrent ischemic stroke in a patient with the Trousseau syndrome treated with dabigatran.
Topics: Aged; Antithrombins; Benzimidazoles; beta-Alanine; Brain Ischemia; Dabigatran; Heparin, Low-Molecula | 2014 |
Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: a case series of three patients.
Topics: Adult; Anticoagulants; Antiphospholipid Syndrome; Benzimidazoles; beta-Alanine; Cerebral Infarction; | 2014 |
The risks of thromboembolism vs. recurrent gastrointestinal bleeding after interruption of systemic anticoagulation in hospitalized inpatients with gastrointestinal bleeding: a prospective study.
Topics: Aged; Aged, 80 and over; Anticoagulants; Benzimidazoles; beta-Alanine; Cohort Studies; Dabigatran; E | 2015 |
Prevention of Dabigatran-Related Gastrointestinal Bleeding With Gastroprotective Agents: A Population-Based Study.
Topics: Aged; Aged, 80 and over; Antithrombins; Benzimidazoles; beta-Alanine; Dabigatran; Female; Gastrointe | 2015 |
Switching patients from warfarin to dabigatran therapy: to RE-LY or not to rely.
Topics: Aged; Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Coronary Thrombosis; Dabiga | 2012 |
Thrombotic events after discontinuing dabigatran: rebound or resumption?
Topics: Aged, 80 and over; Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Humans; Middle Aged; Re | 2012 |
Dabigatran in recurrent deep vein thrombosis: when one-size does not fit all.
Topics: Aged, 80 and over; Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Humans; Male; Recurrenc | 2012 |