SWITCH: Apixaban vs Vitamin K in HM3

Sponsor
Columbia University
Study ID
NCT07471139
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Bleeding
  • Heart Failure
  • Heart Transplant
  • LVAD (Left Ventricular Assist Device) Thrombosis
  • Stroke
  • Thrombosis; Artery

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Warfarin — DRUG
    Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8
  • Apixaban — DRUG
    Apixaban 5 mg bid (twice a day)

Study Details

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.

Key Dates

First listed
Mar 13, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
460 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Warfarin
    Participants will take warfarin, dose titrated for an INR \>= 1.8
  • Experimental: Apixaban
    Participants wil take apixaban 5 mg bid

Primary Outcome Measure

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

Central Contacts

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