NCT07471139

SWITCH: Apixaban vs Vitamin K in HM3

The SWITCH Trial: A Randomized Controlled Study of Apixaban Versus Vitamin K Antagonists in Patients With HeartMate 3 Left Ventricular Assist Devices

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart failure is a global epidemic, and Left Ventricular Assist Devices (LVADs) - particularly the HeartMate 3 (HM3) - are increasingly used due to their survival benefit over medical therapy. Despite advances, hemocompatibility-related adverse events (HRAEs) like thrombosis and bleeding remain significant causes of morbidity and mortality. Direct Oral Anticoagulants (DOACs) have shown superiority over warfarin in heart failure patients, with lower rates of embolic and intracranial bleeding. Reduced-dose DOACs also appear to reduce major bleeding without increasing thrombotic risk. However, data on their use in LVAD patients is limited, consisting mainly of case reports, small series, retrospective analyses, and a few small randomized clinical trials. Some reports suggest apixaban may reduce bleeding in high-risk LVAD patients, though cases of pump thrombosis and stroke have occurred. Early studies comparing DOACs to warfarin in patients with HeartMate II (HMII), HeartWare™ HVAD™ System, and The Abbott HeartMate 3 (HM3) show no significant differences in outcomes, with a trend toward less bleeding with apixaban. Two small randomized clinical trials in HM3 patients (The DOAC LVAD Study and The DOT-HM3 Study) found similar results. This prospective, randomized, controlled, non-inferiority trial will evaluate the safety and efficacy of apixaban versus vitamin K antagonists in HM3 patients more than 3 months post-implant.

Conditions

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

Interventions

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

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2026-03-13
• Last updated: 2026-03-13

Regulatory

• FDA-regulated drug study