Actively Recruiting
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)
Led by University of Florida · Updated on 2025-11-04
40
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the HBR-ARC criteria and HIR defined as ABCD-GENE score ≥10) following PCI. We hypothesize that in patients at dual-risk, switching from standard-dose clopidogrel to low-dose prasugrel will be superior to continuing standard-dose clopidogrel in terms of platelet reactivity.
CONDITIONS
Official 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 had PCI and are on dual antiplatelet therapy with low-dose aspirin (81 mg daily) and clopidogrel (75 mg 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 within the last 30 days
- Hemodynamic instability
- Current treatment with any oral anticoagulant or chronic low-molecular-weight heparin for thrombosis treatment
- Known allergy or hypersensitivity to aspirin, clopidogrel, or prasugrel
- Known blood cancers or low platelet count (below 80 x 10^6/mL)
- Known hemoglobin disorders or anemia (hemoglobin below 9 g/dL)
- Pregnant or breastfeeding women (women of childbearing age must use reliable birth control during the study)
AI-Screening
AI-Powered Screening
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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
CONTACT
A
Andrea Burton, MPH, CCRP
CONTACT
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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