SWITCH: Apixaban vs Vitamin K in HM3
NCT07471139 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460
Last updated 2026-03-13
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
- Heart Transplant
Interventions
- DRUG
-
Warfarin
Warfarin dose titrated for an International Normalized Ratio (INR) \>= 1.8
- DRUG
-
Apixaban
Apixaban 5 mg bid (twice a day)
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Nir Uriel, MD · New York Presbyterian / Columbia University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2029-06-30
- Completion
- 2029-06-30
- FDA Drug
- Yes
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