NCT07025148PHASE4Recruiting
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)
University of Florida
Start Date
10/1/2025
Completion Date
11/1/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* Patients with high bleeding risk (defined according to the ARC-HBR criteria) who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin (81mg qd) with clopidogrel (75 mg qd) as part of standard of care for at least 30 days.
* Age ≥18 years.
* Provide written informed consent.
Exclusion Criteria:
* Prior cerebrovascular event.
* PCI within 30 days.
* Hemodynamic instability.
* On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis).
* Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel.
* Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL).
* Known hemoglobinopathies or anemia (hemoglobin \<9 g/dL)
* Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].
Interventions
DRUG
Prasugrel
DRUG
Clopidogrel
Conditions
Coronary Arterial Disease (CAD)Percutaneous Coronary Intervention (PCI)
Locations
University of Florida Health
Jacksonville, Florida 32209
United States