Clinical trials: Factor Xa Inhibitor
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
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, 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
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
Peripheral Arterial Disease, Venous Thormboembolism
VTE Incidence After Rivaroxaban + Aspirin or SAPT After Lower-limb Revascularization
Venous thromboembolism (VTE) has a high prevalence in patients with multiple comorbidities undergoing complex surgical procedures.
- Conditions
- Peripheral Arterial Disease, Venous Thormboembolism, Cardiovascular Diseases, Vascular Surgery Patient with PAD / Carotid Stenosis
- Trial name
- RESOLUTION (NCT06873321)
- Testing
- rivaroxaban 2.5 mg bid + aspirin 100 mg, clopidogrel 75 mg od for 3 months followed by aspirin 100 mg od for endovascular procedures or aspirin for open procedures
- Where
- Brazil
- Volunteers
- 100 people
- Sponsor
- Science Valley Research Institute
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
Atrium; Fibrillation, Chronic Kidney Diseases
Vitamin K AntagonISt, Factor Xa Inhibitor or No Anticoagulation in Atrial Fibrillation and DIalytic End-stage Renal DiseasE (VISIONAIRE)
VISIONAIRE (Vitamin K AntagonISt, Factor Xa Inhibitor Or Nothing In Atrial Fibrillation And DIalytic End-stage Renal DiseasE) trial will be a prospective randomized open-label with blinded endpoint adjudication trial including…
- Trial name
- VISIONAIRE (NCT06402851)
- Testing
- Anticoagulant Oral
- Where
- 6 sites in Brazil
- Volunteers
- 1,500 people
- Sponsor
- Hospital Sirio-Libanes
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
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
Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT)
Extended Prophylactic Anticoagulation Following Spinal Surgery for Metastatic Disease
People who have surgery on their spine to treat cancer that has spread (metastatic disease) have a high chance of developing dangerous blood clots in the legs or lungs.
- Conditions
- Venous Thromboembolism (VTE), Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Spine Metastasis
- Trial name
- NCT07713875
- Testing
- Apixaban
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- James Bayley
Cirrhosis, Esophageal and Gastric Varices
Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis
The APIXABAN-PK trial is a prospective, randomized, single-blind, placebo-controlled study designed to evaluate the efficacy and safety of apixaban in combination with carvedilol versus placebo with carvedilol in preventing…
- Conditions
- Cirrhosis, Esophageal and Gastric Varices, Ascites, Hepatic Encephalopathy
- Trial name
- APIXABAN-PK (NCT07521332)
- Testing
- Apixaban, Carvedilol
- Where
- Pakistan
- Volunteers
- 220 people
- Sponsor
- Asian Institute Of Medical Sciences
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
Covid19
Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT)
This study is a multicenter, randomized trial to study the potential benefit of treatments with a direct FXa inhibitor (rivaroxaban) versus standard of care dose subcutaneous low molecular weight heparin (LMWH) (Lovenox) in…
- Trial name
- XACT (NCT04640181)
- Testing
- Enoxaparin, Rivaroxaban
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- St. David's HealthCare
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
AORTIC VALVE DISEASES, Thromboembolism
Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
- Trial name
- RENOVATE (NCT04258488)
- Testing
- Rivaroxaban Oral Tablet, Vitamin K antagonist(warfarin)
- Where
- 16 sites in South Korea
- Volunteers
- 1,300 people
- Sponsor
- Joon Bum Kim
COVID-19, Venous Thromboembolism
Clinical Trial of Dimolegin (DD217) in Prevention of Thrombotic Complications in Patients With COVID-19
Study purpose was to study the safety and efficacy of Dimolegin - DD217 as a drug for prevention of thrombotic complications compared to Clexane (enoxaparin sodium) - the standard therapy currently prescribed to patients…
- Trial name
- NCT05185804
- Testing
- Dimolegin, Clexane
- Where
- 6 sites in Russia
- Volunteers
- 399 people
- Sponsor
- PharmaDiall Ltd.
SCAD, AMI
Effects of Edoxaban on Platelet Aggregation
Rationale: The interaction between nonvitamin K oral anticoagulants (NOACs) and platelet aggregation is complex. The direct activated factor X inhibitors (factor Xa inhibitors) an NOAC antagonizes thrombin generation, one of most…
- Trial name
- Edoxaban (NCT05122455)
- Testing
- ASA, Clopidogrel, Edoxaban
- Where
- Brazil
- Volunteers
- 61 people
- Sponsor
- University of Sao Paulo
Major Bleeding, Major Bleeding Outcomes
Observational Study to Characterize Patients Experiencing Major Acute Bleeding Events During Anticoagulation Treatment With Oral Factor Xa Inhibitors.
Oral factor Xa inhibitors are widely used for the prevention of cardioembolic events in patients with atrial fibrillation and for the treatment of venous thromboembolism, thanks to their good efficacy/safety ratio compared to…
- Trial name
- EMERALD (NCT07745933)
- Where
- Italy
- Volunteers
- 503 people
- Sponsor
- Fadoi Foundation, Italy
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
Anticoagulation, Venous Thromboembolism
Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels
Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay.
- Conditions
- Anticoagulation, Venous Thromboembolism, Atrial Fibrillation
- Trial name
- UniXa (NCT04539301)
- Testing
- Estimated anticoagulant level (conversion factor x anti-Xa activity)
- Where
- France
- Volunteers
- 2,100 people
- Sponsor
- Nantes University Hospital