SWITCH: Apixaban vs Vitamin K in HM3

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorColumbia University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Warfarin
  • Apixaban

Treatment groups

460 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators