Clinical trials: Factor Xa Inhibitor
Atrial Fibrillation
Direct Factor Xa Inhibitor YM150 for Prevention of Stroke in Subjects With Non-Valvular Atrial Fibrillation
To evaluate the safety and tolerability of YM150 in subjects with non-valvular atrial fibrillation (NVAF)and to obtain information on pharmacokinetics and pharmacodynamics (anti-thrombotic potential) in the target population
- Trial name
- NCT00448214
- Testing
- YM150, warfarin
- Where
- 18 sites in Australia, Hong Kong and 8 more
- Volunteers
- 448 people
- Sponsor
- Astellas Pharma Inc
Venous Thromboembolism
An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism After Total Knee Replacement: a Dose-Ranging Study
The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells).
- Trial name
- NCT00402467
- Testing
- Rivaroxaban (BAY59-7939), Rivaroxaban, (BAY59-7939), Enoxaparine
- Where
- 36 sites in United States, Canada
- Volunteers
- 613 people
- Sponsor
- Bayer
Venous Thromboembolism, Thromboembolism
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
The objective of this study is to compare the efficacy, safety of DU-176b 30mg or DU-176b 15mg versus enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
- Conditions
- Venous Thromboembolism, Thromboembolism, Thrombosis, Embolism and Thrombosis
- Trial name
- NCT01203098
- Testing
- DU-176b 15mg, DU-176b 30mg, Enoxaparin sodium 20 mg (=2000IU)
- Where
- 3 sites in Japan, Taiwan
- Volunteers
- 264 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Coagulation Disorder
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in…
- Trial name
- NCT05156983
- Testing
- TAK-330, SOC 4F-PCC
- Where
- 64 sites in United States, Argentina and 13 more
- Volunteers
- 440 people
- Sponsor
- Takeda
Atrial Fibrillation
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (originally described in Japanese).
- Trial name
- NCT00973323
- Testing
- Xarelto (Rivaroxaban, BAY59-7939), Warfarin
- Where
- 10 sites in Japan
- Volunteers
- 100 people
- Sponsor
- Bayer
Surgery
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.
- Trial name
- Annexa-S (NCT04233073)
- Testing
- andexanet alfa
- Where
- 56 sites in United States, Austria and 4 more
- Volunteers
- 10 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Angioplasty, Transluminal, Percutaneous Coronary
The SEPIA-PCI Trial: Otamixaban in Comparison to Heparin in Subjects Undergoing Non-Urgent Percutaneous Coronary Intervention
The objective of this dose-ranging study is to determine the effects of several intravenous (IV) regimens of otamixaban on pharmacodynamic markers (including markers of thrombosis and coagulation markers), safety/tolerability…
- Trial name
- SEPIA-PCI (NCT00133731)
- Testing
- Otamixaban (XRP0673), Unfractionated Heparin, Percutaneous Coronary Intervention
- Where
- 89 sites in United States, Belgium and 8 more
- Volunteers
- 947 people
- Sponsor
- Sanofi
Venous Thromboembolism
Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement
The purpose of this study is to determine if TAK-442, once daily (QD) or twice daily (BID), is as safe and effective as enoxaparin in preventing the development of blood clots after knee replacement surgery.
- Trial name
- NCT00641732
- Testing
- TAK-442, Enoxaparin
- Where
- 64 sites in United States, Canada
- Volunteers
- 1,045 people
- Sponsor
- Takeda
Venous Thromboembolism
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the…
- Trial name
- NCT00395772
- Testing
- Xarelto (Rivaroxaban, BAY59-7939), (LMW) Heparin + Vitamin K Antagonist
- Where
- 78 sites in United States, Australia and 11 more
- Volunteers
- 543 people
- Sponsor
- Bayer
Venous Thromboembolism, Deep Vein Thrombosis
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
- Conditions
- Venous Thromboembolism, Deep Vein Thrombosis, Total Knee Arthroplasty
- Trial name
- NCT01203072
- Testing
- DU-176b
- Where
- 2 sites in Japan
- Volunteers
- 523 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Acute Intracranial Hemorrhage
Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant
- Trial name
- NCT03661528
- Testing
- andexanet alfa, Usual Care
- Where
- 142 sites in United States, Austria and 22 more
- Volunteers
- 530 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Total Knee Replacement
Safety and Efficacy of TeaRx Xa Factor Direct Inhibitor Versus Enoxaparin as a Venous Thromboembolic Events (VTE) Prevention Following Total Knee Replacement
To evaluate influence of therapy on the following efficacy and safety parameters in different TeaRx dose groups and Enoxaparin group: Total venous thromboembolic events (VTE), which includes confirmed deep venous thrombosis…
- Trial name
- NCT03088358
- Testing
- TeaRx, Enoxaparin
- Where
- 8 sites in Russia
- Volunteers
- 200 people
- Sponsor
- TeaRx LLC
Healthy Volunteers
A Study to Access Safety, Tolerability, Pharmacokinetics(PK) and Pharmacodynamics(PD) of Orally Administered GCC-4401C in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability and Pharmacokinetics/Pharmacodynamics of multiple doses of GCC-4401C in healthy male subjects.
- Trial name
- NCT01954238
- Testing
- GCC-4401C, Rivaroxaban
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Green Cross Corporation
Urgent Surgery
A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures.
- Trial name
- ANNEXA-RS (NCT05926349)
- Testing
- Andexanet alfa, Usual Care
- Sponsor
- AstraZeneca
Atrial Fibrillation
A Study Evaluating Safety and Tolerability of YM150 Compared to Warfarin in Subjects With Atrial Fibrillation
The purpose of this study is to investigate the optimal daily dose and dose regimen of YM150 in subjects with non-valvular atrial fibrillation (NVAF), primarily based on safety and tolerability data.
- Trial name
- OPAL-2 (NCT00938730)
- Testing
- YM150, Warfarin
- Where
- 170 sites in Australia, Austria and 21 more
- Volunteers
- 1,280 people
- Sponsor
- Astellas Pharma Inc
Venous Thromboembolism
YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness
To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.
- Trial name
- NCT01028950
- Testing
- YM150
- Where
- 5 sites in Japan
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Inc
Venous Thrombosis, Deep Vein Thrombosis
Deep Vein Thrombosis Treatment With the Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients Using a Strong CYP 3A4 Inducer
This is a multicenter, cohort study evaluating an adapted rivaroxaban dose regimen in patients with acute, proximal deep-vein thrombosis (DVT) or acute pulmonary embolism (PE) who concomitantly use a strong cytochrome P450…
- Trial name
- NCT00786422
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 16 sites in Australia, Austria and 7 more
- Volunteers
- 25 people
- Sponsor
- Bayer
Venous Thromboembolism
A Study to Assess the Effect of YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
The purpose of the study is to evaluate the efficacy and safety of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients undergoing major abdominal surgery.
- Trial name
- NCT00942435
- Testing
- YM150, mechanical prophylaxis
- Where
- 6 sites in Japan
- Volunteers
- 156 people
- Sponsor
- Astellas Pharma Inc
Prophylaxis, Thromboembolism, Venous, Total Knee Replacement
Study to Observe Safety of Xarelto in VTE Prophlylaxis After Elective TKR (Total Knee Replacement) or THR (Total Hip Replacement)
The primary objective of this study is to evaluate the safety of Xarelto in the prophylaxis of VTE in Indian patients undergoing elective TKR/THR
- Conditions
- Prophylaxis, Thromboembolism, Venous, Total Knee Replacement, Total Hip Replacement
- Trial name
- XYRIS (NCT01523418)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Sponsor
- Bayer
Healthy Participants
A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
The purpose of this study is to characterize andexanet posology and interaction between andexanet and enoxaparin post infusion in healthy participants.
- Trial name
- NCT07312851
- Testing
- Andexanet alfa, Rivaroxaban, Apixaban
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- AstraZeneca