Recruiting

Aspirin & Hemocompatibility

Sponsor:

Columbia University

Code:

NCT06655376

Conditions

Bleeding

Clot Blood

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aspirin

Warfarin

Study Details

Brief 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

Bleeding

Clot Blood

Study ID

NCT06655376

Start date

Oct 2, 2024

Status verified date

Feb, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant will have HeartMate3 LVAD implanted > 3 months before enrollment.
  • >18 years old
  • Treated with aspirin and VKA
  • Participant must provide written informed consent prior to any clinical investigation-related procedure

Exclusion Criteria:

  • Investigator-mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent)
  • Participation in any other clinical investigation(s) involving an 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
  • Pregnant and on appropriate contraception

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Aspirin

81-100 mg, oral

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nir Uriel, MD

2123057600nu2126@cumc.columbia.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Columbia Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Nir Uriel, MD

212-305-7600nu2126@cumc.columbia.edu

Principal Investigator:

Nir Uriel, MD

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Columbia University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-27.