460 Participants NeededMy employer runs this trial

Apixaban for Heart Failure

IR
Overseen ByIlan Richter, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

NU

Nir Uriel, MD

Principal Investigator

New York Presbyterian / Columbia University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced heart failure who have had a HeartMate 3 LVAD implanted for over 3 months and are currently taking warfarin. Participants must not be pregnant and must agree to use contraception if they can become pregnant.

Inclusion Criteria

* Participant must provide written informed consent prior to any clinical investigation related procedure
I am 18 years old or older.
I am not pregnant and I am using birth control.
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What Are the Treatments Tested in This Trial?

Interventions

  • Apixaban
  • Warfarin

Trial Overview

The study compares two blood thinners, apixaban and warfarin, to see which better prevents blood clots and bleeding in people with a HeartMate 3 LVAD. Participants are randomly assigned to one of the treatments.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: ApixabanExperimental Treatment1 Intervention
Group II: WarfarinActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+