Apixaban Versus Warfarin for Left Ventricular Thrombus

NCT07709780 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00007421
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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

Keywords

Cardiac Thrombus; Intracardiac Thrombus; Systemic Embolism; Stroke

Outcome Measures

Primary Outcomes (1)

• Complete Left Ventricular Thrombus Resolution at 3 Months

  Proportion of participants with complete resolution of left ventricular thrombus at 3 months, assessed by cardiac magnetic resonance imaging. The primary noninferiority comparison will use the absolute between-group difference in the proportion of participants with complete thrombus resolution, apixaban minus warfarin.

  3 months after randomization

Secondary Outcomes (8)

• Major Bleeding

  6 months

• Change in LV Thrombus Volume

  Baseline to 3, 6, or 12 months

• Left Ventricular Remodeling

  Baseline to 3, 6,12 months

• Recurrent LV Thrombus

  12 months

• Ischemic Stroke

  12 months

Study Arms (2)

Apixaban

EXPERIMENTAL

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

Drug: Apixaban

Warfarin

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

Apixaban DRUG

Apixaban 5 mg orally twice daily

Apixaban

Warfarin DRUG

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

Warfarin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center - Tucson

Tucson, Arizona, 85724, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

apixaban; Warfarin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Tushar Acharya, MD, MPH

CONTACT

520-626-0968; tacharya@arizona.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 17, 2026
• Study Start: June 22, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)