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NCT06655376 · ClinicalTrials.gov registry record · Phase 4
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
A Phase 4 study of Bleeding and Clot Blood, sponsored by Columbia University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 128
- Enrollment target
- 3
- Study locations
NCT06655376: Recruiting Phase 4 study of Bleeding and Clot Blood, sponsored by Columbia University.
NCT06655376 is a Phase 4 study of Bleeding and Clot Blood that is actively recruiting participants, run by Columbia University. The registered enrollment target is 128 participants, below the 1,479-participant average among 23 other Bleeding trials with a reported enrollment target (91% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06655376, a Phase 4 study of Bleeding and Clot Blood, is actively recruiting participants, sponsored by Columbia University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 128 participants
- Enrollment target
- 3
- Study locations
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.
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 4 |
What NCT06655376 shows while recruiting
NCT06655376 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 1,479-participant average among 23 other Bleeding trials with a reported enrollment target (91% lower).
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.
NCT06655376 reports a single indexed study location in Illinois, New York, Texas.
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.
What interventions are being tested in trial NCT06655376?
The interventions under investigation include: Aspirin (DRUG), Warfarin (DRUG).
Who is sponsoring clinical trial NCT06655376?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06655376's enrollment target sits among peer trials
128 15th of 23 higher than 9 of 23 other Bleeding trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bleeding trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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