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Apixaban Versus Warfarin for Left Ventricular Thrombus

ConditionLeft Ventricular Thrombus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apixaban

    Drug

    Apixaban 5 mg orally twice daily

  • Warfarin

    Drug

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

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: ApixabanExperimental treatment 1 intervention
Group B: WarfarinActive comparator 1 intervention

Trial outcomes

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.

Time frame
3 months after randomization

Secondary outcomes

1

Major Bleeding

Proportion of participants with major bleeding defined as BARC type 3 or 5 bleeding.

Time frame
6 months
2

Change in LV Thrombus Volume

Change in thrombus volume assessed by CMR

Time frame
Baseline to 3, 6, or 12 months
3

Left Ventricular Remodeling

Change in left ventricular ejection fraction and left ventricular volumes on follow-up imaging.

Time frame
Baseline to 3, 6,12 months
4

Recurrent LV Thrombus

Proportion of participants with recurrent LV thrombus after documented resolution.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

Source ClinicalTrials.gov
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