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)
Recruiting now · Phase 4
Conditions studied: Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
In brief
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.
Key facts
- Study ID
- NCT07025148
- Run by
- University of Florida
- People needed
- 40
- Starts
- 2025-10-01
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2025-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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].
Where it is running
- University of Florida Health — Jacksonville, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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