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Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device

NCT06655376 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-02-27

No results posted yet for this study

Summary

Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management. Improving outcomes have been seen with the newer LVAD technology, the HeartMate 3 (Abbott, Chicago, IL), however, hemocompatibility related adverse events, including thrombosis and bleeding, are still a major cause of morbidity and mortality. The recent ARIES trial showed that in patients with advanced heart failure treated with a HeartMate3 LVAD, avoidance of aspirin as part of an antithrombotic regimen, which includes vitamin K antagonist (VKA), is not inferior to a regimen containing aspirin, does not increase thromboembolism risk, and is associated with a reduction in bleeding events.

This clinical investigation is a prospective, randomized, controlled study of advanced heart failure patients supports with the HeartMate3 for more then 3 months with two different antithrombotic regimens: VKA with and without aspirin. The objective of this investigation is to study the safety and efficacy of an antithrombotic regimen without antiplatelet therapy.

Conditions

Interventions

DRUG

Aspirin

81-100 mg, oral

DRUG

Warfarin

Warfarin dose will be adjusted per patient for a goal INR 2-3. The individualized daily dose could range anywhere from 0.5-2 mg to 5-7 mg. Oral.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Columbia University

    lead OTHER

Principal Investigators

  • Nir Uriel, MD · Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2027-04-01
Completion
2027-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655376 on ClinicalTrials.gov