Clinical trials: Oral Anticoagulants
Uterine Hemorrhage
A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
The purpose of this study is assess the: (a) incidence of severe uterine bleeding (SUB) following exposure to individual direct oral anticoagulant (DOACs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual DOACs…
- Trial name
- NCT04394234
- Testing
- Direct oral anticoagulant (DOACs), Warfarin
- Where
- United States
- Volunteers
- 961,985 people
- Sponsor
- Janssen Research & Development, LLC
Coagulation Disorder
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH)…
- Trial name
- NCT06517563
- Testing
- VMX-C001, Rivaroxaban, UFH
- Where
- Netherlands
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- VarmX B.V.
Atrial Fibrillation
Explore the Efficacy and Safety of Once-daily Oral Rivaroxaban for the Prevention of Cardiovascular Events in Subjects With Nonvalvular Atrial Fibrillation Scheduled for Cardioversion
A study for patients with abnormal heart rhythm (atrial fibrillation) who need to undergo cardioversion (procedure to restore normal heart rhythm).
- Trial name
- X-VERT (NCT01674647)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA)
- Where
- 178 sites in United States, Belgium and 15 more
- Volunteers
- 1,504 people
- Sponsor
- Bayer
Atrial Fibrillation
A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)
The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.
- Trial name
- EQUAL-AF (NCT05044533)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Bristol-Myers Squibb
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.
Atrial Fibrillation, Obesity
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare
The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who…
- Conditions
- Atrial Fibrillation, Obesity, Anticoagulants
- Trial name
- NCT04681482
- Testing
- Apixaban
- Where
- United States
- Volunteers
- 107,383 people
- Sponsor
- Pfizer
Atrial Fibrillation
Burden of Ischemic Stroke and Intake of Oral Anticoagulants in Patients With Atrial Fibrillation in the UK Primary Care
This study will characterize patients with ischemic stroke, a condition which occurs when a vessel supplying blood to the brain is obstructed, and a subpopulation of patients with irregular and often rapid heart rate (atrial…
- Trial name
- BEST-AF (NCT04099238)
- Testing
- Oral anticoagulant
- Where
- United Kingdom
- Volunteers
- 3,739 people
- Sponsor
- Bayer
Non-valvular Atrial Fibrillation
Safety and Effectiveness of Oral Anticoagulants in Patients With Non-valvular Atrial Fibrillation
An anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular AF (NVAF) patients. Warfarin, a vitamin K antagonist, is the first oral anticoagulant approved for the treatment for prevention of…
- Trial name
- CER3 (NCT03570047)
- Where
- Japan
- Volunteers
- 73,989 people
- Sponsor
- Pfizer
Stroke
Use of Direct Oral Anticoagulants in UK
Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it.
- Trial name
- NCT03119116
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Dabigatran, Apixaban
- Where
- United Kingdom
- Volunteers
- 31,336 people
- Sponsor
- Bayer
Coagulation
Clinical Performance Evaluation of Native Whole Blood Samples of Patients on DOACs With the Perosphere ClotChek™
The Perosphere ClotChek™ system consists of a hand-held, battery-operated blood coagulation instrument and disposable test cuvettes for use at the point-of-care (POC).
- Trial name
- NCT07012291
- Testing
- Whole Blood Clotting Time
- Where
- 4 sites in United States
- Volunteers
- 150 people
- Sponsor
- Perosphere Technologies Inc.
Coagulation Disorder
Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant
A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: Part 1: Single dose of…
- Trial name
- NCT06372483
- Testing
- VMX-C001, Rivaroxaban 20 mg Oral Tablet, Apixaban 5 mg Oral Tablet
- Where
- Netherlands
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- VarmX B.V.
Anticoagulant Therapy
Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects
DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation.
- Trial name
- PHAPOCU (NCT05491460)
- Testing
- Apixaban 5 MG Tab, Dabigatran 150 MG Tab, Edoxaban 60Mg Tab
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Doasense GmbH
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 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.
Emergency Care for Severe Bleeding While on Anticoagulants
Use of Prothrombin Complex Concentrate in Patients Admitted in Emergency Care Units for Severe Bleeding While Receiving Oral Anticoagulants
The study is assessing the impact of an expert eCRF on the management of severe bleeding in the administration of Prothrombin Complex Concentrate in patients treated with oral anticoagulants and adherence to recommendations or…
- Trial name
- NCT03320603
- Testing
- Expert eCRF, Prothrombin Complex Concentrate
- Where
- 26 sites in France
- Volunteers
- 397 people
- Sponsor
- Octapharma
CPB, Oral Anticoagulant Therapy
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery
The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).
- Trial name
- NCT00151853
- Testing
- PPSB-SD
- Where
- Belgium
- Volunteers
- 40 people
- Sponsor
- Prothya Biosolutions
Non-valvular Atrial Fibrillation
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment
To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients…
- Trial name
- NCT01857622
- Testing
- DU-176b 15mg, DU-176b 30mg, DU-176b 60mg
- Where
- Japan
- Volunteers
- 93 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Venous Thromboembolism, Embolism and Thrombosis
Factor IX Inhibition in Thrombosis Prevention (The FIXIT Trial)
The purpose of this study is to determine whether TTP889 prevents venous thromboembolism following surgery to repair hip fracture.
- Conditions
- Venous Thromboembolism, Embolism and Thrombosis, Hip Fractures
- Trial name
- NCT00119457
- Testing
- TTP889
- Where
- 21 sites in Czechia, Denmark and 2 more
- Volunteers
- 300 people
- Sponsor
- vTv Therapeutics
Blood Loss, Surgical, Coagulation Disorder
Phase 3 Trial of Reltodecacog Alfa (VMX-C001) vs Usual Pharmacological Care in Patients Taking a FXa Direct Oral Anticoagulant Who Require Urgent Surgery With or Without Heparin.
The goal of this clinical trial is to learn if reltodecacog alfa (VMX-C001) works to to allow blood clotting control in participants who take FXa Direct Oral Anticoagulants (DOACs) during surgery or other invasive procedures that…
- Trial name
- EQUILIBRIX-S (NCT07288489)
- Testing
- Reltodecacog alfa, Usual Pharmacological Care
- Where
- 77 sites in United States, Australia and 16 more
- Volunteers
- 800 people
- Sponsor
- VarmX B.V.
Non-valvular Atrial Fibrillation
A Nationwide Observational Study Looking at Effectiveness and Bleeding Complications of NOACs vs. VKA in Non-valvular Atrial Fibrillation Patients.
Using mandatory nationwide registries and possibly hospital electronic medical records in Norway, the researchers want to understand how well a group of drugs called "non-vitamin K antagonist oral anticoagulants" (rivaroxaban …
- Trial name
- PROTECT-AF (NCT03715725)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Apixaban (Eliquis), Dabigatran etexilate (Pradaxa)
- Where
- Norway
- Volunteers
- 70,000 people
- Sponsor
- Bayer