Table of Contents
- Clinical trial overview
- Patient groups being studied
- Trial phases and study designs
- Main endpoints and outcomes
- Imaging tests and follow-up periods
- What participation means in these studies
- Key trials using Warfarin Sodium
Clinical trial overview
The trials in this set study Warfarin Sodium in people with different conditions linked to blood clots and bleeding risk.[1][2] Most studies are designed to compare Warfarin Sodium with other anticoagulants, with no treatment, or with another antithrombotic strategy.[1][3]
These are mostly Phase 3 trials, which means they are testing treatments in larger groups and comparing results across groups.[1][6] One study is in Phase 4, which usually looks at treatment effects after wider use has already started.[5]
Patient groups being studied
Several trials focus on people with atrial fibrillation, a heart rhythm problem that can increase the risk of stroke and blood clots.[2][5][8] Other studies include patients on dialysis, people after heart surgery, and patients with clots inside the heart or left ventricle.[1][3][7]
Some studies also include people after transcatheter aortic valve implantation, often called TAVI, which is a procedure to place a new aortic valve without open-heart surgery.[6] One trial looks at people with acute venous thromboembolism who are also taking antiplatelet therapy for artery protection.[9]
Trial phases and study designs
All of the listed studies are interventional, meaning researchers assign the treatment plan and then compare outcomes.[1][4] The trials include randomized controlled designs, open-label designs, and pragmatic multicenter studies, which means they are built to reflect real-world care in more than one hospital or center.[1][4]
Enrollment ranges from small exploratory work to very large studies, from 100 participants up to 2,600 participants in the listed trials.[4][6] This wide range shows that some studies are focused on detailed safety checks, while others aim to compare treatment strategies in broader patient groups.[2][9]
Main endpoints and outcomes
The main outcomes often measure bleeding events, stroke, embolism, death, or whether a clot gets smaller or disappears.[1][3][7] Some trials use a composite endpoint, which means several important outcomes are grouped together in one main result.[2][5]
For example, one study measures clinically significant major or non-major bleeding, while another looks at stroke, peripheral embolism, and major bleeding events together.[1][2] Another trial focuses on net clinical benefit, which combines death, heart attack, stroke, embolism, clot persistence, and relevant bleeding in a single outcome.[3]
Some studies use specific bleeding scales, such as ISTH, GUSTO, TIMI, BARC, or VARC-3, to classify how serious a bleeding event is.[1][5][6][9] These scales help researchers compare results in a standard way.
Imaging tests and follow-up periods
Several trials use imaging tests to see whether a clot has resolved or whether a valve looks changed over time.[7][6] For example, one study checks thrombus resolution with transthoracic echocardiography, and if that is unclear, it may use cardiac MRI or cardiac CT.[7]
Follow-up times vary by study. Some outcomes are measured at 3 months, 6 months, 12 months, or even 2 years, depending on the condition and the goal of the trial.[3][5][7][8]
What participation means in these studies
People in these trials are usually already living with a condition that raises clotting or bleeding concerns, such as atrial fibrillation, dialysis, recent heart procedures, or a known clot.[1][6][8] The studies compare different treatment approaches so researchers can see which strategy gives the best balance between preventing clots and avoiding bleeding.[2][9]
Some trials compare Warfarin Sodium with newer oral anticoagulants such as apixaban, rivaroxaban, dabigatran, or edoxaban.[1][2][7] Other studies compare Warfarin Sodium with no anticoagulant treatment or with different antithrombotic plans after a procedure.[2][5]
Key trials using Warfarin Sodium
NCT06045858 is a Phase 3 randomized study in people with end-stage renal disease on chronic peritoneal dialysis and non-valvular atrial fibrillation.[1] It compares apixaban with warfarin and measures clinically significant bleeding over 12 months.[1]
2022-502986-92-00 is a large Phase 3 study in atrial fibrillation after surgical left atrial appendage closure.[2] It looks at whether anticoagulant therapy, including Warfarin Sodium, changes the risk of stroke, peripheral embolism, and major bleeding.[2]
2024-512685-33-00 studies people with intra-cardiac thrombus and compares direct oral anticoagulants with vitamin K antagonist therapy, including warfarin.[3] Its main result is a 6-month net clinical benefit endpoint that includes death, heart attack, stroke, embolism, clot persistence, and bleeding.[3]
NCT06696079 is a Phase 4 study in chronic subdural hematoma with atrial fibrillation.[5] It asks whether restarting anticoagulation early or later changes the risk of thromboembolic events, hemorrhagic events, and vascular death.[5]
NCT06449469 studies patients after successful TAVI and measures whether at least one prosthetic valve leaflet shows HALT, which means hypoattenuated leaflet thickening on cardiac CT.[6] This trial looks at how different antithrombotic strategies affect this valve finding over one year.[6]
NCT06515730 compares apixaban and Warfarin Sodium in people with left ventricular thrombus after acute myocardial infarction.[7] The main endpoint is thrombus resolution at 3 months, checked first with echocardiography and then with MRI or cardiac CT if needed.[7]
NCT03862859 studies the safety and efficacy of warfarin in people with atrial fibrillation on dialysis.[8] It compares events such as transient ischemic attack, ischemic stroke, unspecified stroke, or death related to these events between warfarin and no treatment.[8]
NCT05627375 looks at people with acute venous thromboembolism who are also taking antiplatelet therapy.[9] The main outcome is clinically relevant bleeding during full-dose treatment, up to 12 months.[9]
