In short
Clinical trials investigating Warfarin are studying how it performs in specific patient groups, mainly for safety and effectiveness. The trials focus on people with atrial fibrillation, mechanical heart valves, kidney failure on dialysis, and patients after cardiac surgery or with MINOCA. They compare Warfarin with other treatments and measure bleeding, clotting, and quality of life.
Key points
- Clinical trials investigating Warfarin are mainly Phase 3 studies in specific patient groups. The trials focus on people with atrial fibrillation, mechanical heart valves, peritoneal dialysis, and MINOCA. They compare Warfarin with other anticoagulants or related treatments and measure safety, especially bleeding, as well as clotting events and quality of life. One study looks at lower INR ranges in patients with mechanical bileaflet aortic valves. Another study examines Warfarin use after cardiac surgery in people with atrial fibrillation and includes a vanguard phase to test feasibility before the full trial.
Clinical trials overview
The trials in this article study Warfarin in people who need anticoagulation, which means treatment to help prevent blood clots. These studies compare Warfarin with other treatments or different care strategies to see how safe and effective the approaches are in real patient groups.
All four listed studies are Phase 3 trials, which are larger studies used to compare treatments in patient groups and measure important outcomes such as bleeding, clotting, and quality of life.
Patient groups studied
The trials focus on several different patient groups.
- People with non-valvular atrial fibrillation, including patients on chronic peritoneal dialysis, are studied in NCT06045858.
- People with MINOCA, which means myocardial infarction with non-obstructive coronary arteries, are studied in 2024-518724-72-00.
- People with a mechanical bileaflet aortic valve who need Vitamin K Antagonist treatment are studied in NCT03636295.
- People with atrial fibrillation after cardiac surgery are studied in NCT04284839.
These groups are different, but they share a common need: careful clot prevention while trying to reduce harm from bleeding.
What the trials measure
The main things measured in these trials are called endpoints, which are the outcomes researchers use to judge the study results.
- NCT06045858 measures clinically significant major or non-major bleeding over 12 months, using ISTH as the primary score and GUSTO and TIMI as secondary scores.
- 2024-518724-72-00 measures angina status and quality of life at 1 year using the Seattle Angina Questionnaire.
- NCT03636295 measures thrombosis/thromboembolism, including ischemic stroke, systemic thromboembolism, and valve thrombosis, as well as major bleeding.
- NCT04284839 measures major bleeding at 30 days, including bleeding that causes death, affects a critical organ, needs reoperation, leads to hospitalization, or causes a large drop in hemoglobin or a blood transfusion.
These endpoints show that the trials are not only asking whether Warfarin works, but also whether it is safe in each patient group.
Trial phases and study design
The NCT06045858 trial is an interventional randomized controlled trial, meaning patients are assigned to treatment groups by chance. It compares Warfarin with apixaban in 178 patients and is authorised.
The PROMISE study, 2024-518724-72-00, is also interventional and completed, with 145 patients. It studies a precision-medicine approach, which means treatment is chosen after looking carefully at the cause of the patient’s condition.
NCT03636295, the LIMIT trial, is a large Phase 3 study with 2625 participants and is authorised. It looks at whether a lower INR range can help reduce bleeding in people with mechanical bileaflet aortic valves.
NCT04284839, the DANCE trial, is a very large Phase 3 study with 6215 participants and is authorised. Its brief summary says the vanguard phase checks whether a large randomized trial is feasible, and the full trial evaluates safety after cardiac surgery in patients with atrial fibrillation who need oral anticoagulation.
Key trial details
NCT06045858 compares apixaban versus Warfarin in adults with end-stage renal disease on chronic peritoneal dialysis and non-valvular atrial fibrillation. The main concern is bleeding, especially clinically significant major or non-major bleeding over 12 months.
2024-518724-72-00 studies patients with MINOCA and uses a precision-medicine approach with treatment based on the suspected cause of the heart attack. The trial looks at how this approach affects angina and quality of life after 1 year.
NCT03636295 focuses on patients treated with a Vitamin K Antagonist because they have a mechanical bileaflet aortic valve replacement. The study evaluates safety and efficacy of a common, lower INR range, with attention to clotting and major bleeding.
NCT04284839 compares direct oral anticoagulants with Vitamin K Antagonists, including Warfarin, after cardiac surgery in patients with atrial fibrillation. The study pays close attention to major bleeding within 30 days after surgery.
What these studies mean for patients
These trials show that Warfarin is being studied in very specific situations, not as one single treatment for all patients. The researchers are trying to learn where Warfarin may be useful, how it compares with other treatments, and how to reduce serious bleeding while still preventing dangerous clots.
The studies also show different ways to measure success, such as bleeding scores, clotting events, symptom questionnaires, and quality-of-life tools. This helps researchers understand both medical safety and the patient experience.