SWITCH: Apixaban vs Vitamin K in HM3 (NCT07471139) | Clinical Trial Compass
Not Yet RecruitingPhase 3
SWITCH: Apixaban vs Vitamin K in HM3
460 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Survival free of major hemocompatibility related adverse event