Table of Contents
- Clinical trials overview
- Patient groups studied
- What the trials measure
- Trial phases and study design
- Key trial details
- What these studies mean for patients
Clinical trials overview
The trials in this article study Warfarin in people who need anticoagulation, which means treatment to help prevent blood clots.[1] These studies compare Warfarin with other treatments or different care strategies to see how safe and effective the approaches are in real patient groups.[1]
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.[1]
Patient groups studied
The trials focus on several different patient groups.[1]
- People with non-valvular atrial fibrillation, including patients on chronic peritoneal dialysis, are studied in NCT06045858.[1]
- People with MINOCA, which means myocardial infarction with non-obstructive coronary arteries, are studied in 2024-518724-72-00.[2]
- People with a mechanical bileaflet aortic valve who need Vitamin K Antagonist treatment are studied in NCT03636295.[3]
- People with atrial fibrillation after cardiac surgery are studied in NCT04284839.[4]
These groups are different, but they share a common need: careful clot prevention while trying to reduce harm from bleeding.[1][3][4]
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.[1]
- 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.[1]
- 2024-518724-72-00 measures angina status and quality of life at 1 year using the Seattle Angina Questionnaire.[2]
- NCT03636295 measures thrombosis/thromboembolism, including ischemic stroke, systemic thromboembolism, and valve thrombosis, as well as major bleeding.[3]
- 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.[4]
These endpoints show that the trials are not only asking whether Warfarin works, but also whether it is safe in each patient group.[1][3][4]
Trial phases and study design
The NCT06045858 trial is an interventional randomized controlled trial, meaning patients are assigned to treatment groups by chance.[1] It compares Warfarin with apixaban in 178 patients and is authorised.[1]
The PROMISE study, 2024-518724-72-00, is also interventional and completed, with 145 patients.[2] It studies a precision-medicine approach, which means treatment is chosen after looking carefully at the cause of the patient’s condition.[2]
NCT03636295, the LIMIT trial, is a large Phase 3 study with 2625 participants and is authorised.[3] It looks at whether a lower INR range can help reduce bleeding in people with mechanical bileaflet aortic valves.[3]
NCT04284839, the DANCE trial, is a very large Phase 3 study with 6215 participants and is authorised.[4] 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.[4]
Key trial details
NCT06045858 compares apixaban versus Warfarin in adults with end-stage renal disease on chronic peritoneal dialysis and non-valvular atrial fibrillation.[1] The main concern is bleeding, especially clinically significant major or non-major bleeding over 12 months.[1]
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.[2] The trial looks at how this approach affects angina and quality of life after 1 year.[2]
NCT03636295 focuses on patients treated with a Vitamin K Antagonist because they have a mechanical bileaflet aortic valve replacement.[3] The study evaluates safety and efficacy of a common, lower INR range, with attention to clotting and major bleeding.[3]
NCT04284839 compares direct oral anticoagulants with Vitamin K Antagonists, including Warfarin, after cardiac surgery in patients with atrial fibrillation.[4] The study pays close attention to major bleeding within 30 days after surgery.[4]
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.[1][2][3][4] 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.[1][3][4]
The studies also show different ways to measure success, such as bleeding scores, clotting events, symptom questionnaires, and quality-of-life tools.[1][2][3][4] This helps researchers understand both medical safety and the patient experience.[2]
