Clinical trials: Factor Xa Inhibitor
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
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.
Healthy
Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote
This is a single center, double-blind, randomized, placebo-controlled, ascending, single dose study of PRT064445 or its matching placebo, in healthy subjects.
- Trial name
- NCT03218241
- Testing
- PRT064445
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Portola Pharmaceuticals
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
Life Threatening Bleeding, Factor Xa Inhibitor
Ondexxya for Intravenous Injection 200mg Drug Use Result Investigation (All Case Investigation)
This survey will be conducted to investigate the status of occurrence of the safety specifications set for "Safety specification" in patients who received Ondexxya Intravenous Injection 200 mg.
- Trial name
- NCT05454787
- Where
- 54 sites in Japan
- Volunteers
- 300 people
- Sponsor
- AstraZeneca
Hemorrhage
Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya
This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals.
- Trial name
- NCT05898412
- Testing
- Andexanet alfa
- Where
- Netherlands
- Volunteers
- 217 people
- Sponsor
- AstraZeneca
Acute Major Bleeding
Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor
This is a multicentre, prospective, randomised, double-blinded, group-sequential, parallel-group, adaptive design, phase 3 study to demonstrate the haemostatic efficacy and safety of four-factor prothrombin complex concentrate…
- Trial name
- NCT04867837
- Testing
- Octaplex
- Where
- 63 sites in United States, Austria and 11 more
- Volunteers
- 100 people
- Sponsor
- Octapharma
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
Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)
This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future…
- Trial name
- NCT00541320
- Testing
- GW813893
- Where
- 8 sites in United States
- Sponsor
- GlaxoSmithKline
Cardiovascular Disease, Coronary Artery Disease
Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention
Balloon angioplasty (Percutaneous Coronary Intervention (PCI)) is commonly used to treat patients with obstructive coronary artery disease (CAD).
- Trial name
- X-PLORER (NCT01442792)
- Testing
- UFH, Rivaroxaban (Xarelto, BAY59-7939), Rivaroxaban (Xarelto, BAY59-7939) and UFH
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 108 people
- Sponsor
- Bayer
Atrial Fibrillation
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Japanese subjects with non-valvular atrial…
- Trial name
- NCT00973245
- Testing
- Xarelto (Rivaroxaban, BAY59-7939), Warfarin
- Where
- 11 sites in Japan
- Volunteers
- 102 people
- Sponsor
- Bayer
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
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.
Thromboembolism
Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
Evaluate the safety and tolerability of escalating oral doses of YM150 in patients undergoing elective primary total knee replacement surgery
- Trial name
- PEARL-1 (NCT00408239)
- Testing
- YM150, enoxaparin
- Where
- 19 sites in Indonesia, Japan and 6 more
- Volunteers
- 367 people
- Sponsor
- Astellas Pharma Inc
Thromboembolism
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.
- Trial name
- NCT00353678
- Testing
- YM150
- Where
- 79 sites in Austria, Bosnia and Herzegovina and 15 more
- Volunteers
- 1,141 people
- Sponsor
- Astellas Pharma Inc
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
Major Bleeding
A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
REVERXaL study aims to increase the understanding of the patient characteristics, bleeding presentation, health care interventions provided, and the clinical as well as self-reported health outcomes of patients with major…
- Trial name
- REVERXaL (NCT06147830)
- Testing
- None (Observational study)
- Where
- 75 sites in United States, Germany and 2 more
- Volunteers
- 2,202 people
- Sponsor
- AstraZeneca
Thromboembolism, Prevention
ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial
Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but…
- Trial name
- ODiXaHip (NCT00839826)
- Testing
- Rivaroxaban (BAY59-7939), Enoxaparin
- Where
- 41 sites in Austria, Belgium and 9 more
- Volunteers
- 641 people
- Sponsor
- Bayer
Venous Thrombosis
Phase I Study of Direct Coagulation Factor Xa Inhibitor SYHA136 Tablets in Chinese Healthy Volunteers
The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study. The trial planned to enroll fifty-six healthy volunteers.
- Trial name
- NCT04036656
- Testing
- SYHA136 0.5 mg, SYHA136 1 mg, SYHA136 2.5 mg
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Venous Thrombosis, Pulmonary Embolism
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.
- Trial name
- NCT00097357
- Testing
- Apixaban, Enoxaparin, Warfarin
- Where
- 147 sites in United States, Argentina and 7 more
- Volunteers
- 1,238 people
- Sponsor
- Bristol-Myers Squibb