Study of Switching from Standard-Dose Clopidogrel to Low-Dose Prasugrel in Patients at High Risk of Bleeding and Ischemic Events After PCI

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.

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)