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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)

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
18 years and older
All
Phase 4

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Overview

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 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 \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Study details
    Coronary Arterial Disease (CAD)
    Percutaneous Coronary Intervention (PCI)

NCT07025148

University of Florida

31 January 2026

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