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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Columbia University
Study ID
NCT06655376
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Bleeding
  • Clot Blood

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aspirin — DRUG
    81-100 mg, oral
  • Warfarin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 2, 2024
Status verified
Feb 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Warfarin without Aspirin
    Participants will only take Warfarin.
  • Active Comparator: Warfarin and Aspirin
    This is the control arm. Participants will take Warfarin and aspirin, which is the standard of care.

Primary Outcome Measure

Number of survival free patients of any major hemocompatibility related adverse events. [ Time Frame: 1 year post implant ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Columbia Irving Medical CenterNew YorkNew York10032
Nir Uriel, MD
[email protected]
212-305-7600
Nir Uriel, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas Health Science Center at HoustonHoustonTexas77030-

Find similar trials in Chicago, IL

By research site
University of Chicago· Chicago, ILColumbia Irving Medical Center· New York, NYThe University of Texas Health Science Center at Houston· Houston, TX

Related Studies