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)
Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)
University of Florida
40 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria8
- 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 \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Prasugrel 5 mg od for 30 ± 5 days
Clopidogrel 75 mg od for 30 ± 5 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07025148