Apixaban vs Warfarin for a Left Ventricular Thrombus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 randomized, noninferiority trial enrolling adults with a recently confirmed left ventricular thrombus. Participants are assigned 1:1 to receive either apixaban or warfarin for anticoagulation for at least 3 months, with follow-up up to 12 months. The primary outcome is complete thrombus resolution at 3 months as seen on cardiac MRI. The trial evaluates effectiveness and safety in real-world patients, acknowledging differences in monitoring and potential drug interactions between the two therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* LV thrombus confirmed within 14 days prior to randomization by CMR or contrast TTE or cardiac CT; baseline CMR required pre-randomization (or ≤7 days post-randomization if clinically unavoidable)
* Candidate for oral anticoagulation for ≥3 months
* Able to provide informed consent.

Exclusion Criteria:

* Absolute indication for VKA (mechanical valve, moderate-severe rheumatic MS and antiphospholipid syndrome) or clear preference or contraindication for one of the study drugs precluding randomization (see below)
* Antiphospholipid syndrome
* Estimated CrCl \<15 mL/min or dialysis
* Severe hepatic impairment (ICD-10: K70.40, K70.41, K71.10, K71.11, K72.00, K72.01, K72.10, K72.11, K72.90, K72.91)
* Active clinically significant bleeding
* Platelets \<50,000/µL
* Pregnancy or lactation; women of childbearing potential unwilling to use contraception
* Life expectancy \<1 year or other conditions compromising follow-up

Additional contraindications to use of warfarin or apixaban. This includes, but is not limited to:

* Active pathological bleeding, major bleeding diathesis, or known blood dyscrasia
* Recent or planned surgery involving the central nervous system or eye, traumatic surgery with large open surfaces, or procedures (spinal/epidural puncture or major regional block anesthesia) where bleeding cannot be safely controlled.
* Conditions associated with high risk of bleeding such as threatened abortion, eclampsia, severe preeclampsia, or malignant/uncontrolled hypertension.
* History of severe hypersensitivity or allergy to warfarin or apixaban.
* Ongoing treatment with a combined P-gp and strong CYP3A4 inhibitor or inducer that cannot be safely discontinued or substituted. Examples include strong combined inhibitors such as ketoconazole, itraconazole, ritonavir or posiconazole, and strong combined inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort.

Where it's running

• Banner University Medical Center - Tucson
  Tucson, Arizona, United States Recruiting

Study contacts

• Study coordinator: Tushar Acharya, MD, MPH
• Email: tacharya@arizona.edu
• Phone: 520-626-0968

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for patients with left ventricular thrombus

  This study is gathering information from people with blood clots in the heart to better understand the condition and improve treatment options.

  Recruiting at 5 sites Queen Mary University of London · Cambridge, Cambridgeshire and 7 other locations · NCT06963567

• Using Apixaban to prevent blood clots after heart attacks

  This study is testing if a low dose of Apixaban can help prevent blood clots in people who have had a heart attack and have weak heart function.

  Recruiting Phase 3 National Institute of Cardiovascular Diseases, Pakistan · Karachi, Sindh · NCT06742567

• Apixaban versus warfarin for left ventricular clot after a heart attack

  This compares apixaban and warfarin to see which better clears left-ventricular blood clots in adults after a heart attack.

  Recruiting at 3 sites Phase 4 Karolinska Institutet · Falun and 15 other locations · NCT06515730

• Anticoagulation After a Heart Attack with Left Ventricular Clot

  This study tests whether adding rivaroxaban to standard dual antiplatelet therapy helps people who develop a left ventricular thrombus after a STEMI.

  Recruiting Jilin University · Changchun, Jilin · NCT05892042

• Comparing anticoagulants for treating left ventricular thrombus after heart attacks in Nepal

  This study is testing whether two blood-thinning medications, Rivaroxaban and Warfarin, can help people in Nepal with blood clots in the heart after a heart attack.

  Recruiting Phase 4 Shahid Gangalal National Heart Centre · Kathmandu, Bagmati · NCT05794399

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.