Recruiting
Phase 3

Apixaban vs. Warfarin

Sponsor:

University of Arizona

Code:

NCT07709780

Conditions

Left Ventricular Thrombus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Apixaban

Warfarin

Study Details

Brief summary:

Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and drug interactions. Apixaban is a direct oral factor Xa inhibitor with fixed dosing and no routine anticoagulation monitoring requirement, and it is increasingly used in clinical practice for left ventricular thrombus, although definitive randomized evidence remains limited.

This randomized, noninferiority trial will compare apixaban with warfarin for treatment of left ventricular thrombus. Eligible adults with recently confirmed left ventricular thrombus will be randomized 1:1 to apixaban or warfarin. The primary endpoint is complete left ventricular thrombus resolution at 3 months assessed by cardiac magnetic resonance imaging. Participants will be followed through 12 months for thrombus-related, bleeding, cardiovascular, and mortality outcomes.

Conditions

Left Ventricular Thrombus

Study ID

NCT07709780

Start date

Jun 22, 2026

Status verified date

Jun, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Apixaban

Participants randomized to apixaban will receive oral apixaban for treatment of left ventricular thrombus according to standard clinical dosing and follow-up.

active comparator: Warfarin

Participants randomized to warfarin will receive oral dose-adjusted warfarin for treatment of left ventricular thrombus according to standard clinical care.

Interventions

Apixaban

Apixaban 5 mg orally twice daily

Warfarin

Warfarin will be prescribed with dose adjustment to maintain INR 2.0-3.0.

Primary outcome measure

  • Complete Left Ventricular Thrombus Resolution at 3 Months [ Time Frame: 3 months after randomization ]

Central Contacts and Locations

Central contacts

Tushar Acharya, MD, MPH

520-626-0968tacharya@arizona.edu

Locations

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85724

Principal Investigator:

Tushar Acharya, MD, MPH

More Information

Sponsor

University of Arizona

Last update posted

Jul 17, 2026

Last verified

Jun, 2026

Keywords

  • Cardiac Thrombus
  • Intracardiac Thrombus
  • Systemic Embolism
  • Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-07-17.