Actively Recruiting
Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)
Led by University of Florida · Updated on 2025-11-04
40
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the platelet effects of switching from standard-dose clopidogrel to low-dose prasugrel compared to continuing standard-dose clopidogrel in patients who are at high risk for both bleeding and ischemic events following percutaneous coronary intervention (PCI). This study focuses on patients defined by specific criteria for high bleeding risk and high ischemic risk using the ARC-HBR definition and ABCD-GENE score, aiming to determine if switching therapies improves platelet reactivity. Participants will be randomly assigned to one of three groups: one continuing clopidogrel-based dual antiplatelet therapy (DAPT), another switching to low-dose prasugrel-based DAPT, and a control group consisting of patients at high bleeding risk but not high ischemic risk continuing clopidogrel-based DAPT per standard care. Prasugrel will be given at 5 mg once daily for about 30 days, and clopidogrel at 75 mg once daily for the same period. During the study, platelet reactivity will be measured after 30 days to assess the primary outcome. Participants will be monitored throughout the treatment period for response to therapy and safety. The study is designed to last until November 2027, and participants must meet specific eligibility requirements, including age and prior treatments, to be included in the trial.
CONDITIONS
Brief Title
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with high bleeding risk defined by ARC-HBR criteria who have undergone PCI and are on maintenance dual antiplatelet therapy with low-dose aspirin (81 mg once daily) and clopidogrel (75 mg once daily) for at least 30 days
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- Prior cerebrovascular event
- PCI performed within the last 30 days
- Hemodynamic instability
- Currently treated with any oral anticoagulant or chronic low-molecular-weight heparin for venous thrombosis
- Known hypersensitivity to aspirin, clopidogrel, or prasugrel
- Known hematologic malignancies or thrombocytopenia (platelet count less than 80 x 10^6/mL)
- Known hemoglobinopathies or anemia (hemoglobin less than 9 g/dL)
- Pregnant or breastfeeding women (women of childbearing age must use reliable birth control during the study)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 30 ± 5 days
Participants receive either low-dose prasugrel or standard-dose clopidogrel as dual antiplatelet therapy for their condition.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
University of Florida Health
Jacksonville, Florida, United States, 32209
Actively Recruiting
Research Team
L
Luis Ortega-Paz, MD, PhD
A
Andrea Burton, MPH, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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