Clinical trials: Vitamin K
Healthy Volunteers
Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact.
- Trial name
- NCT05205863
- Testing
- Cofact
- Where
- Netherlands
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Prothya Biosolutions
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
Bleeding From Teeth, Bleeding Prophylaxis
Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction
The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.
- Trial name
- NCT06143787
- Testing
- Tranexamic acid
- Where
- 19 sites in United States, Croatia and 3 more
- Volunteers
- 280 people
- Sponsor
- Hyloris Developments
Thrombosis
Vitamin K2 Intervention in Patients With Vitamin K Antagonists
The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy…
- Trial name
- SAFEK (NCT01533441)
- Testing
- Vitamin K2
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Danisco
Pulmonary Embolism, Deep Vein Thrombosis
SR34006 Compared to Placebo in Patients Who Have Completed 6 Months of Treatment for Symptomatic Pulmonary Embolism or Deep Vein Thrombosis
Patients diagnosed with pulmonary embolism (blood clot in the lung) or deep vein thrombosis (blood clot in a leg vein) are at risk for these blood clots to reoccur.
- Trial name
- NCT00071279
- Testing
- SR34006 (idraparinux sodium) Injection
- Where
- 65 sites in United States, Australia and 18 more
- Volunteers
- 1,215 people
- Sponsor
- Sanofi
Atrial Fibrillation
Treatment Pattern of NOACs (Non-vitamin K Oral Anticoagulants) in Outpatient Users in Colombian Databases
This population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the…
- Trial name
- TREND (NCT03474757)
- Testing
- Data Collection
- Where
- Colombia
- Volunteers
- 10,528 people
- Sponsor
- Bayer
Atrial Fibrillation, Stroke
Amplatzer Amulet LAAO vs. NOAC
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for…
- Conditions
- Atrial Fibrillation, Stroke, Bleeding
- Trial name
- CATALYST (NCT04226547)
- Testing
- Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder), Non-Vitamin K Oral Antagonists
- Where
- 127 sites in United States, Australia and 14 more
- Volunteers
- 2,650 people
- Sponsor
- Abbott Medical Devices
Venous Thromboembolism
Treatment Patterns and Bleeding Risk of Anticoagulants in Patients With Venous Thromboembolism in Korea
This study is a retrospective, observational, nationwide population-based cohort study utilizing the South Korea's Health Insurance and Review Assessment Service (HIRA) database.
- Trial name
- NCT05022563
- Testing
- Parenteral anticoagulant, Warfarin, Apixaban
- Where
- 2 sites in South Korea
- Volunteers
- 55,759 people
- Sponsor
- Pfizer
Venous Thromboembolism
Xarelto Regulatory Post-Marketing Surveillance
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large…
- Trial name
- NCT01029743
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
- Where
- South Korea
- Volunteers
- 3,388 people
- Sponsor
- Bayer
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
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
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
Atrial Fibrillation
BAY 59-7939 (Xarelto, SPAF), Non Interventional Studies
According to recent guidelines, long-term anticoagulation is recommended for patients with atrial fibrillation (AF) and a risk profile with CHA2DS2-VASc score of 1 or more.
- Trial name
- NCT02090543
- Testing
- Phenprocoumon (Marcumar), Rivaroxaban (Xarelto, BAY-59 7939)
- Where
- Germany
- Volunteers
- 647 people
- Sponsor
- Bayer
Vitamin K-Dependent Coagulation Defect, Significant Bleeding Risk
Post Marketing Observational Study on Safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
Post marketing observational study on safety of BALFAXAR vs. KCENTRA for Reversal of Vitamin K Antagonist Induced Anticoagulation in Adults Undergoing Urgent Surgery or Invasive Procedure
- Trial name
- NCT06429787
- Testing
- Balfaxar, Kcentra
- Where
- United States
- Volunteers
- 3,574 people
- Sponsor
- Octapharma
Reversal of Anticoagulant Treatment
Study of Octaplex (Human Prothrombin Complex Concentrate) and Fresh Frozen Plasma in Patients Under Vitamin K Therapy Antagonist Needing Urgent Surgery or Invasive Procedures
The purpose of this study is to determine whether Octaplex (human prothrombin complex concentrate) can reverse the effects of anticoagulants when compared to the standard treatment of fresh frozen plasma (FFP).
- Trial name
- NCT00618098
- Testing
- Octaplex (human prothrombin complex concentrate), Fresh frozen plasma
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Octapharma
Blood Clots, Infection and Inflammatory Reaction
Cobas® Lumira Collection of Venous and Capillary Blood Samples for the Research, Optimization and Calibration of New Diagnostic Devices
This study is a blood sample collection study, collecting venous and capillary blood samples from adult patients in the UK, with a range of health conditions.
- Conditions
- Blood Clots, Infection and Inflammatory Reaction, Heart Disease, Kidney Disease
- Trial name
- EVOLVE (NCT07378514)
- Testing
- Blood samples are obtained and pseudonymized, prior to use for the development, optimization and calibration of diagnostic tests
- Volunteers
- 30,000 people
- Sponsor
- LumiraDx UK Limited
Atrial Fibrillation
Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Factor Xa Non-vitamin-K Oral Anticoagulants (NOACs) vs. Phenprocoumon
Existing real-world studies have provided evidence that novel oral anticoagulants (NOACs) in general and rivaroxaban in particular are more effective and at least as safe as warfarin in non-valvular atrial fibrillation (NVAF)…
- Trial name
- ReLoaDeD (NCT03563937)
- Testing
- Phenprocoumon, Apixaban, Rivaroxaban (Xarelto, BAY59-7939)
- Where
- Germany
- Volunteers
- 64,920 people
- Sponsor
- Bayer
Atrial Fibrillation
Analysis of the Potential Savings of Rivaroxaban Events Versus Vitamin K Antagonists Events
The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs…
- Trial name
- NCT03462446
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonists (VKAs)
- Where
- Spain
- Volunteers
- 249 people
- Sponsor
- Bayer
Mitral Valve Stenosis, Atrial Fibrillation
Efficacy and Safety of Rivaroxiban Compare With Vitamin K Antagonist Warfarin
Title: Efficacy and safety of rivaroxiban compare with vitamin K antagonist warfarin in patients with atrial fibrillation and mitral stenosis among Pakistani population.
- Trial name
- NCT03673605
- Testing
- Rivaroxaban 15 mg, Warfarin
- Where
- Pakistan
- Sponsor
- PharmEvo Pvt Ltd
Venous Thromboembolism
Long-Term Innohep® Treatment Versus a Vitamin K Antagonist (Warfarin) for the Treatment of Venous Thromboembolism (VTE) in Cancer
The purpose of this study is to assess the efficacy and safety of Innohep® in preventing the recurrence of VTE in patients with active cancer who have had an acute VTE episode.
- Trial name
- NCT01130025
- Testing
- Warfarin, Innohep®
- Where
- Canada
- Volunteers
- 900 people
- Sponsor
- LEO Pharma