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Aspirin + Warfarin for Congestive Heart Failure

Phase 4
Recruiting
Led By Nir Uriel, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant is >18 years old
Participant is treated with aspirin and VKA
Must not have
Investigator-mandated antiplatelet therapy for other conditions
Pregnant and on appropriate contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial studied patients with advanced heart failure who were using a HeartMate3 LVAD for more than 3 months. They compared two antithrombotic regimens: one with a blood thinner

Who is the study for?
This trial is for advanced heart failure patients who have been supported by the HeartMate3 device for over three months. It's not clear what specific exclusion criteria are, but typically, participants would need to be stable enough to follow the trial procedures and not have conditions that could interfere with the study or their safety.
What is being tested?
The study is testing two blood-thinning strategies in heart failure patients using HeartMate3: one includes both warfarin (a vitamin K antagonist) and aspirin, while the other uses only warfarin. The goal is to see if dropping aspirin reduces bleeding without increasing clotting risks.
What are the potential side effects?
Potential side effects may include increased risk of bleeding with aspirin use and possible blood clots with either treatment. Warfarin requires regular monitoring as it can cause various side effects like bruising or serious bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.
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I am currently taking aspirin and a vitamin K antagonist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on prescribed medication to prevent blood clots for another condition.
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I am not pregnant and am using birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of survival free patients of any major hemocompatibility related adverse events.
Secondary study objectives
Bleeding Incidence
Number of Non-surgical Major Hemorrhagic Events
Number of Non-surgical Major Thrombotic Events
+3 more
Other study objectives
Averaged Days of hospitalization
Hemocompatibility Score
Number of Rehospitalizations
+1 more

Side effects data

From 2016 Phase 3 trial • 2199 Patients • NCT02072434
5%
Atrial fibrillation
1%
International normalised ratio increased
1%
Cardiac failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Warfarin
Edoxaban

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Warfarin without AspirinExperimental Treatment1 Intervention
Participants will only take Warfarin.
Group II: Warfarin and AspirinActive Control2 Interventions
This is the control arm. Participants will take Warfarin and aspirin, which is the standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Warfarin
2017
Completed Phase 4
~248220

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,488 Previous Clinical Trials
2,664,032 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,087 Previous Clinical Trials
1,148,619 Total Patients Enrolled
Nir Uriel, MDPrincipal InvestigatorSeymour, Paul, and Gloria Milstein Professor of Cardiology at Columbia University
5 Previous Clinical Trials
460 Total Patients Enrolled
~85 spots leftby Apr 2027
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