Clinical trials: Anticoagulant
Hemorrhage
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism…
- Trial name
- NCT02815670
- Testing
- Idarucizumab
- Where
- 2 sites in Russia
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Atrial Fibrillation
Anticoagulants Comparative Benefit-risk Ratio in Real Life
The study is an analysis using the French national health insurance database, six months after the beginning of NOAC launch in the NVAF indication.
- Trial name
- NCT02785354
- Where
- France
- Volunteers
- 103,101 people
- Sponsor
- Boehringer Ingelheim
Reversal of Coagulopathy
An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX® P/N (Kcentra) Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure
The purpose of this study is to evaluate efficacy, safety and tolerance of Beriplex® P/N (Kcentra) compared with plasma in regard to rapid reversal of coagulopathy induced by vitamin K antagonists in subjects who require…
- Trial name
- BE1116_3003 (NCT00803101)
- Testing
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Where
- 30 sites in United States, Belarus and 4 more
- Volunteers
- 176 people
- Sponsor
- CSL Behring
Fibrillation, Atrial
Evaluation of Fondaparinux in Patients With a Heart Rhythm Disturbance Who Undergo Restoration of Normal Heart Rhythm
The purpose of this study is to test whether Fondaparinux is effective and safe to prevent thromboembolic events (like for example strokes) and bleeding events in patients who undergo a normalisation of their heart rhythm…
- Trial name
- NCT00911300
- Testing
- fondaparinux, unfractionated heparin, Vitamin-K-Antagonist
- Where
- 34 sites in France, Germany
- Volunteers
- 349 people
- Sponsor
- GlaxoSmithKline
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.
Thromboembolism
Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR)…
- Trial name
- RE-COVER II (NCT00680186)
- Testing
- Warfarin, Dabigatran etexilate
- Where
- 220 sites in United States, Australia and 29 more
- Volunteers
- 2,589 people
- Sponsor
- Boehringer Ingelheim
Healthy Male Volunteers
A Study in Healthy Male Participants to Compare How CHF10196 Affects How the Body Absorbs and Processes Two Commonly Used Medicines: Dabigatran, a Blood Thinner, and Rosuvastatin, a Medicine Used to Lower Cholesterol
The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a…
- Trial name
- NCT07744386
- Testing
- Dabigatran Etexilate, Rosuvastatin, CHF10196
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
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, Deep Venous Thrombosis
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE
This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal…
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis, Pulmonary Embolism
- Trial name
- MAGNOLIA (NCT05171075)
- Testing
- Abelacimab, Dalteparin
- Where
- 117 sites in United States, Australia and 18 more
- Volunteers
- 417 people
- Sponsor
- Anthos Therapeutics, Inc.
Atrial Fibrillation
Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey
This is a national, multi-center, prospective study to evaluate the safety of Edoxaban in patients diagnosed with AF who are currently using Edoxaban for stroke prevention.
- Trial name
- ETAF-TR (NCT04594915)
- Testing
- Edoxaban
- Where
- 45 sites in Turkey (Türkiye)
- Volunteers
- 1,053 people
- Sponsor
- Daiichi Sankyo Turkey, a Daiichi Sankyo Company
Atrial Fibrillation
Comparative Effectiveness of Oral Anticoagulants
This cohort study plans to identify initiators of oral anticoagulants using electronic claims data from a commercial insurance database to quantify associations between anticoagulant choice (warfarin and dabigatran) and the…
- Trial name
- NCT01847547
- Volunteers
- 5,982 people
- Sponsor
- Boehringer Ingelheim
Thrombosis
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis
The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.
- Trial name
- DESIR-ABLE (NCT00913133)
- Testing
- Desirudin
- Where
- 16 sites in United States
- Volunteers
- 516 people
- Sponsor
- Canyon Pharmaceuticals, Inc.
Non-valvular Atrial Fibrillation (NVAF)
AMPLATZER™ Cardiac Plug Observational Post-Approval Study
The purpose of this study is to observe the safety and effectiveness of the AMPLATZER™ Cardiac Plug (ACP) device in Chinese population indicated for use of AMPLATZER™ Cardiac Plug after its market approval by China FDA (CFDA).
- Trial name
- ACP China (NCT02954237)
- Testing
- AMPLATZER™ Cardiac Plug
- Where
- 6 sites in China
- Volunteers
- 91 people
- Sponsor
- Abbott Medical Devices
Atrial Fibrillation, Stroke
An Efficacy and Safety Study of Rivaroxaban With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Patients With Non-Valvular Atrial Fibrillation
The purpose of this study is to compare the efficacy and safety of rivaroxaban with warfarin for the prevention of blood clots in the brain (referred to as stroke) and blood clots in other parts of the body referred to as…
- Conditions
- Atrial Fibrillation, Stroke, Embolism
- Trial name
- NCT00403767
- Testing
- Rivaroxaban, Warfarin
- Where
- 932 sites in United States, Argentina and 42 more
- Volunteers
- 14,269 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Venous Thromboembolism
Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)
The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)
- Trial name
- PREDICARE (NCT03099031)
- Testing
- Tinzaparin
- Where
- France
- Volunteers
- 420 people
- Sponsor
- LEO Pharma
Non-valvular Atrial Fibrillation
Study to Describe Risk of Bleeding in Patients Depending on the Different Anticoagulant Therapy They Are on for Atrial Fibrillation (AF)
Study of patients with nonvalvular atrial fibrillation (NVAF) who are newly prescribed NOACs (Novel Oral Anticoagulants) in routine clinical practice in England
- Trial name
- NCT03508258
- Testing
- Non-interventional
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
Healthy
Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI 655075 following intravenous administration of single rising doses of BI 655075 when administered alone and after administration of…
- Trial name
- NCT02028780
- Testing
- Idarucizumab, dabigatran
- Where
- Japan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Whole Blood Donations and Leukoreduction
Clinical Investigation to Evaluate the Hemanext® Red Blood Cell Processing System for Extended Storage of Leukoreduced Red Blood Cells
The primary goal of Hemanext Inc. is to improve the safety and efficacy of transfusion therapy through novel storage methods potentially improving their quality across the storage cycle.
- Trial name
- NCT04418934
- Testing
- Hemanext One
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Hemanext
Blood Coagulation Disorder
Evaluation of Clinical Ranges of Whole Blood Clotting Times of Patients on Anticoagulants
Whole blood clotting time measurements are to collect the clotting time ranges for DOAC-anticoagulated patients and assess their correlation with plasma drug levels (via anti-FXa assay).
- Trial name
- NCT06582563
- Testing
- Whole Blood Clotting Time
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Perosphere Technologies Inc.
Significant Bleeding Risk
Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex® P/N (Kcentra) for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.
To demonstrate that the efficacy of OCTAPLEX as a reversal agent in patients under Vitamin K Antagonist (VKA) therapy with the need for urgent surgery with significant bleeding risk is clinically non-inferior to that Beriplex®…
- Trial name
- NCT02740335
- Testing
- Octaplex, Beriplex P/N (Kcentra)
- Where
- 86 sites in United States, Belarus and 9 more
- Volunteers
- 208 people
- Sponsor
- Octapharma