Recruiting
Phase 3

Apixaban vs. Warfarin

Sponsor:

Columbia University

Code:

NCT07471139

Conditions

LVAD (Left Ventricular Assist Device) Thrombosis

Heart Failure

Bleeding

Thrombosis; Artery

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Warfarin

Apixaban

Study Details

Brief summary:

This study is being done to learn the safety and efficacy of a new anticoagulant therapy with apixaban as compared to warfarin to prevent thrombotic events while protecting from bleeding complications in patients with advanced heart failure who are chronically supported by a HeartMate 3 Left Ventricular Assist Device for 3 months.

Conditions

LVAD (Left Ventricular Assist Device) Thrombosis

Heart Failure

Bleeding

Thrombosis; Artery

Stroke

Study ID

NCT07471139

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants will have HeartMate3 LVAD implanted > 3 months before enrollment
  • ≥ 18 years old
  • Treated with WARFARIN SODIUM
  • Participant must provide written informed consent prior to any clinical investigation related procedure
  • In female participants of childbearing capability, not currently pregnant and on appropriate contraception

Exclusion Criteria:

  • Participation in any other clinical investigation(s) involving a Mechanical Circulatory Support (MCS) device, or interventional investigation(s) likely to confound study results or affect study outcome
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
  • Known allergy to Apixaban
  • Bridge to transplant
  • Severe renal dysfunction Estimated Glomerular Filtration Rate (eGFR) <20
  • History of major bleeding event with subsequent reduction of INR goal to < 1.8
  • Apixaban dose reduction criteria (Age ≥80 years, weight ≤60 kg, creatinine ≥1.5 mg/dL)
  • Aortic root thrombus

Study Design

Enrollment

460 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Warfarin

Participants will take warfarin, dose titrated for an INR >= 1.8

experimental: Apixaban

Participants wil take apixaban 5 mg bid

Interventions

Warfarin

Warfarin dose titrated for an International Normalized Ratio (INR) >= 1.8

Apixaban

Apixaban 5 mg bid (twice a day)

Primary outcome measure

  • Survival free of major hemocompatibility related adverse event [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ilan Richter, MD

3322098345ir2498@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Ilan Richter, MD

212-305-7600ir2498@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Nov 4, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Columbia University on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.