Bleeding study: Aspirin vs Warfarin
Official title Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
ClinicalTrials.gov ID: NCT06655376
What this study is testing
What is Aspirin?
An investigational antiplatelet regimen being studied for bleeding risk in patients with advanced heart failure supported by a HeartMate 3 LVAD. Aspirin is designed to inhibit platelet aggregation by blocking the COX-1 enzyme.
Also referred to as acetylsalicylic acid.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see whether not using aspirin, together with a vitamin K antagonist, is safe and works as well as using aspirin for preventing clots in these patients.
- Who it's for
- Adults with advanced heart failure who have had a HeartMate 3 left‑ventricular assist device implanted for at least three months.
- What's involved
- Participants will be randomly assigned to take a blood‑thinner (vitamin K antagonist) with or without aspirin, and will have regular check‑ups and tests to monitor clotting and bleeding.
- Time commitment
- The trial runs for several months, with periodic clinic visits for medication checks and safety assessments.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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 treatment investigation(s) likely to confound study results or...
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could...
- Pregnant and on appropriate contraception
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States; New York, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.