Evaluating aspirin use in heart failure patients with a heart pump
Delayed ARIES: Aspirin and Hemocompatibility Events in Advanced Heart Failure Patients Chronically Supported With a Left Ventricular Assist Device
This study is testing whether heart failure patients using a heart pump do better with or without aspirin in their blood-thinning treatment to see which option is safer and more effective.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT06655376 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess the safety and efficacy of an antithrombotic regimen without aspirin in patients with advanced heart failure who have been supported by the HeartMate 3 LVAD for over three months. The study is a prospective, randomized, controlled trial comparing two regimens: one that includes vitamin K antagonist (VKA) with aspirin and another that includes VKA without aspirin. The primary endpoint is to determine the composite survival free of major hemocompatibility-related adverse events at one year post-randomization. Secondary endpoints include rates of non-surgical bleeding and thrombotic events, as well as overall survival rates.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have had a HeartMate 3 LVAD implanted for more than three months and are currently treated with aspirin and VKA.
Not a fit: Patients who require mandated antiplatelet therapy for other conditions or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and reduced bleeding risks for heart failure patients using LVADs.
How similar studies have performed: The recent ARIES trial has shown that avoiding aspirin in similar patient populations does not increase thromboembolism risk and may reduce bleeding events, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 2 other locations
- University of Chicago — Chicago, Illinois, United States (Recruiting)
- Columbia Irving Medical Center — New York, New York, United States (Recruiting)
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nir Uriel, MD — Seymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University
- Study coordinator: Nir Uriel, MD
- Email: nu2126@cumc.columbia.edu
- Phone: 2123057600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.