In short
Clinical trials of Warfarin Sodium are studying how well it works and how safe it is in different patient groups. These studies mainly look at bleeding, stroke, blood clots, and other outcomes in people with atrial fibrillation, dialysis, heart valve procedures, and other clotting problems.
Key points
- Clinical trials of Warfarin Sodium are looking at how it performs in several clot-related conditions. Most studies are Phase 3, with one Phase 4 study, and many compare Warfarin Sodium with newer anticoagulants or with no treatment. The main patient groups include people with atrial fibrillation, dialysis, heart valve procedures, intracardiac clot, stroke risk after heart surgery, and acute clotting events. The trials often measure bleeding, stroke, embolism, clot resolution, and death. Some studies also use imaging tests, such as cardiac CT or echocardiography, to check specific treatment effects.
Clinical trial overview
The trials in this set study Warfarin Sodium in people with different conditions linked to blood clots and bleeding risk. Most studies are designed to compare Warfarin Sodium with other anticoagulants, with no treatment, or with another antithrombotic strategy.
These are mostly Phase 3 trials, which means they are testing treatments in larger groups and comparing results across groups. One study is in Phase 4, which usually looks at treatment effects after wider use has already started.
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. Other studies include patients on dialysis, people after heart surgery, and patients with clots inside the heart or left ventricle.
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. One trial looks at people with acute venous thromboembolism who are also taking antiplatelet therapy for artery protection.
Trial phases and study designs
All of the listed studies are interventional, meaning researchers assign the treatment plan and then compare outcomes. 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.
Enrollment ranges from small exploratory work to very large studies, from 100 participants up to 2,600 participants in the listed trials. This wide range shows that some studies are focused on detailed safety checks, while others aim to compare treatment strategies in broader patient groups.
Main endpoints and outcomes
The main outcomes often measure bleeding events, stroke, embolism, death, or whether a clot gets smaller or disappears. Some trials use a composite endpoint, which means several important outcomes are grouped together in one main result.
For example, one study measures clinically significant major or non-major bleeding, while another looks at stroke, peripheral embolism, and major bleeding events together. Another trial focuses on net clinical benefit, which combines death, heart attack, stroke, embolism, clot persistence, and relevant bleeding in a single outcome.
Some studies use specific bleeding scales, such as ISTH, GUSTO, TIMI, BARC, or VARC-3, to classify how serious a bleeding event is. 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. For example, one study checks thrombus resolution with transthoracic echocardiography, and if that is unclear, it may use cardiac MRI or cardiac CT.
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.
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. The studies compare different treatment approaches so researchers can see which strategy gives the best balance between preventing clots and avoiding bleeding.
Some trials compare Warfarin Sodium with newer oral anticoagulants such as apixaban, rivaroxaban, dabigatran, or edoxaban. Other studies compare Warfarin Sodium with no anticoagulant treatment or with different antithrombotic plans after a procedure.
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. It compares apixaban with warfarin and measures clinically significant bleeding over 12 months.
2022-502986-92-00 is a large Phase 3 study in atrial fibrillation after surgical left atrial appendage closure. It looks at whether anticoagulant therapy, including Warfarin Sodium, changes the risk of stroke, peripheral embolism, and major bleeding.
2024-512685-33-00 studies people with intra-cardiac thrombus and compares direct oral anticoagulants with vitamin K antagonist therapy, including warfarin. Its main result is a 6-month net clinical benefit endpoint that includes death, heart attack, stroke, embolism, clot persistence, and bleeding.
NCT06696079 is a Phase 4 study in chronic subdural hematoma with atrial fibrillation. It asks whether restarting anticoagulation early or later changes the risk of thromboembolic events, hemorrhagic events, and vascular death.
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. This trial looks at how different antithrombotic strategies affect this valve finding over one year.
NCT06515730 compares apixaban and Warfarin Sodium in people with left ventricular thrombus after acute myocardial infarction. The main endpoint is thrombus resolution at 3 months, checked first with echocardiography and then with MRI or cardiac CT if needed.
NCT03862859 studies the safety and efficacy of warfarin in people with atrial fibrillation on dialysis. It compares events such as transient ischemic attack, ischemic stroke, unspecified stroke, or death related to these events between warfarin and no treatment.
NCT05627375 looks at people with acute venous thromboembolism who are also taking antiplatelet therapy. The main outcome is clinically relevant bleeding during full-dose treatment, up to 12 months.