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RECRUITING Phase 4

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

NCT06655376 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Aspirin
  • DRUG Warfarin

Study Locations (3)

Illinois

  • University of Chicago — Chicago

New York

  • Columbia Irving Medical Center — New York

Texas

  • The University of Texas Health Science Center at Houston — Houston

Trial Details

FieldValue
Enrollment Target 128 participants
Start Date 2024-10-02
Est. Completion 2027-04-01
Phase Phase 4

Sponsor

Columbia University

875 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06655376

The ClinicalTrials.gov registry entry for NCT06655376 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 875 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Bleeding appearing as the primary indexed condition, and to 2 interventions — of which Aspirin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06655376 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Illinois, New York, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06655376 about?

NCT06655376 is a clinical study titled "Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device". 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...

What is the current status of trial NCT06655376?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2024-10-02. Estimated completion is 2027-04-01.

What conditions does trial NCT06655376 study?

This clinical trial studies the following conditions: Bleeding, Clot Blood. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06655376?

The interventions under investigation include: Aspirin (DRUG), Warfarin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06655376?

This trial is sponsored by Columbia University, which has 875 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06655376 being conducted?

This trial has 3 study locations across Illinois, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial