Apixaban vs Warfarin in HeartMate 3 LVAD Patients

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, non-inferiority trial comparing apixaban to vitamin K antagonists in adults with a HeartMate 3 LVAD implanted for more than 3 months. The study aims to evaluate safety and efficacy in reducing thrombotic events while limiting bleeding complications. Participants will be assigned to either apixaban or warfarin and followed for a defined period to monitor outcomes related to hemocompatibility-related adverse events. Eligibility includes adults with HM3 LVAD >3 months, currently on warfarin, and willing to provide informed consent. Key exclusion criteria include allergy to apixaban, bridge-to-transplant status, and significant renal dysfunction.

Why it matters

Who can join: the full rules

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

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Nir Uriel, MD — New York Presbyterian / Columbia University Medical Center
• Study coordinator: Ilan Richter, MD
• Email: ir2498@cumc.columbia.edu
• Phone: 3322098345

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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.