Evaluating aspirin use in heart failure patients with a heart pump

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Antiplatelet-Only versus Antiplatelet plus Low-Dose Rivaroxaban after Heart Events

  In adults 65 or older with prior heart events and certain arterial diseases, this study tests whether continuing clopidogrel alone is no worse than adding low-dose rivaroxaban to aspirin-based therapy.

  Recruiting Phase 4 Seoul National University Bundang Hospital · Seongnam-si, Gyeonggi-do · NCT07796217

• Multi-omics search for clotting and bleeding markers in coronary heart disease

  This project will test whether combining proteins, metabolites, genes, sugar tags, and heart images can better predict clotting and major bleeding in people with coronary heart disease on dual antiplatelet therapy.

  Recruiting at 3 sites Chinese Academy of Medical Sciences, Fuwai Hospital · Zhengzhou, Henan and 2 other locations · NCT07523880

• Apixaban vs Warfarin in HeartMate 3 LVAD Patients

  This study tests whether apixaban can replace warfarin to prevent clots and bleeding problems in adults with an implanted HeartMate 3 LVAD for at least 3 months.

  Recruiting Phase 3 Columbia University · New York, New York · NCT07471139

• Safety of perioperative blood thinner management in people with cancer undergoing surgery or procedures

  This study tests how safe current practices are for stopping or continuing blood thinners in adults with cancer who are having surgery or procedures, to see if bleeding or clots are affected.

  Recruiting Ottawa Hospital Research Institute · Ottawa · NCT07372716

• Timing of hip fracture surgery for patients on DOAC blood thinners

  This project will see if operating within 24 hours is as safe as delaying surgery for people with hip fractures who recently took DOAC blood thinners by comparing how often they need blood transfusions.

  Recruiting at 7 sites St. Antonius Hospital · Almelo and 6 other locations · NCT07309848

• Emergency care for brain AVM bleeding using a hybrid neurosurgical operating room

  This study will test whether using a hybrid neurosurgical operating room that combines imaging, endovascular treatment, and microsurgery can provide faster one‑stop emergency care for adults (18–70) with acute brain arteriovenous malformation (AVM) bleeding.

  Recruiting Beijing Tiantan Hospital · Beijing · NCT07118631

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.