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)
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: University of Florida
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's recruiting
Jacksonville
Source: ClinicalTrials.gov · NCT07025148 · last updated 2025-11-04