Clinical trials: Factor Xa Inhibitor
Atrial Fibrillation
Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin
Prevention of stroke in patients with atrial fibrillation (AF). Hypothesis: In patients with non-valvular AF, orally administered betrixaban will provide similar or better efficacy and safety than warfarin and it will offer the…
- Trial name
- EXPLORE-Xa (NCT00742859)
- Testing
- betrixaban, Warfarin
- Where
- 21 sites in United States, Canada
- Volunteers
- 508 people
- Sponsor
- Portola Pharmaceuticals
Venous Thromboembolism
A Phase 3 Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
- Trial name
- NCT01181102
- Testing
- edoxaban, enoxaparin sodium
- Where
- 3 sites in Japan, Taiwan
- Volunteers
- 716 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Bleeding
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute…
- Trial name
- NCT02329327
- Testing
- Andexanet
- Where
- 87 sites in United States, Belgium and 7 more
- Volunteers
- 479 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Thromboembolism
Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)
Randomized study of PRT054021 40 mg and 15 mg bid vs. enoxaparin 30 mg q12h for the prophylaxis of venous thromboembolic events after unilateral knee replacement surgery.
- Trial name
- NCT00375609
- Testing
- Betrixaban, Enoxaparin
- Where
- Canada
- Volunteers
- 215 people
- Sponsor
- Portola Pharmaceuticals
Venous Thromboembolism
Once - Daily Oral Direct Factor Xa Inhibitor Rivaroxaban In The Long-Term Prevention Of Recurrent Symptomatic Venous Thromboembolism In Patients With Symptomatic Deep-Vein Thrombosis Or Pulmonary Embolism. The Einstein-Extension Study
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12…
- Trial name
- NCT00439725
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 322 sites in United States, Australia and 31 more
- Volunteers
- 1,197 people
- Sponsor
- Bayer
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.
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.
Prevention, Venous Thromboembolism
A Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Hip Arthroplasty
The objective of this study is to assess the efficacy and safety of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective total hip arthroplasty.
- Trial name
- NCT01181167
- Testing
- edoxaban, enoxaparin sodium
- Where
- 2 sites in Japan
- Volunteers
- 610 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
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.
Venous Thromboembolism
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery.
- Trial name
- NCT01181141
- Testing
- DU-176b (edoxaban), Enoxaparin sodium 20mg
- Where
- Japan
- Volunteers
- 92 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Venous Thrombosis
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without…
- Trial name
- NCT00440193
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin followed by VKA
- Where
- 324 sites in United States, Australia and 32 more
- Volunteers
- 3,449 people
- Sponsor
- Bayer
Pulmonary Embolism
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism - The EINSTEIN PE Study
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary…
- Trial name
- NCT00439777
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Enoxaparin overlapping with and followed by VKA
- Where
- 305 sites in United States, Andorra and 37 more
- Volunteers
- 4,833 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.
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
Vaso-occlusive Crisis, Reduction in Hospitalizations
Apixaban in Patients With Sickle Cell Disease
In patients with SCD, the use of low dose anticoagulation as an outpatient may lead to a significant decrease in morbidity and as a result, decrease healthcare utilization and costs.
- Conditions
- Vaso-occlusive Crisis, Reduction in Hospitalizations, Sickle Cell Disease
- Trial name
- NCT02179177
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Nirmish Shah