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

NCT06655376 | Recruiting Phase 4 FDA Drug

• 1 other identifier: AAAV3358
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Number of survival free patients of any major hemocompatibility related adverse events.

  A Major Hemocompatibility Related Adverse Event is defined as: Stroke, Pump Thrombosis (suspected or confirmed), major non-surgical Bleeding (moderate or severe) (including intracranial bleeds that do not meet the stroke definition), Arterial Peripheral Thromboembolism. The events will be recorded and tallied per patient.

  1 year post implant

Secondary Outcomes (6)

• Number of Non-surgical Major Hemorrhagic Events

  1 year

• Number of Non-surgical Major Thrombotic Events

  1 year

• Survival Rate

  1 year

• Stroke Incidence

  1 year

• Pump Thrombosis Incidence

  1 year

Other Outcomes (4)

• Hemocompatibility Score

  1 year

• Number of Rehospitalizations

  1 year

• Averaged Days of hospitalization

  1 year

Study Arms (2)

Warfarin without Aspirin

EXPERIMENTAL

Participants will only take Warfarin.

Drug: Warfarin

Warfarin and Aspirin

ACTIVE COMPARATOR

This is the control arm. Participants will take Warfarin and aspirin, which is the standard of care.

Drug: Aspirin; Drug: Warfarin

Interventions

Aspirin DRUG

81-100 mg, oral

Also known as: ASPIRIN® tablets

Warfarin and Aspirin

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.

Also known as: Vitamin K antagonist, COUMADIN

Warfarin and Aspirin; Warfarin without Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Weill Medical College of Cornell University: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Columbia Irving Medical Center

New York, New York, 10032, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Thrombosis

Interventions

Aspirin; Warfarin; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Nir Uriel, MD

  Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nir Uriel, MD

CONTACT

2123057600; nu2126@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology (in Medicine)

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (3)