RECRUITING Phase 4 ClinicalTrials.gov

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)

Sponsor: University of Florida • ClinicalTrials.gov ID: NCT07025148

Registry updated: 2026-10-07

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Description

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.

Interventions

Prasugrel (Drug)
Prasugrel 5 mg od for 30 ± 5 days
Clopidogrel (Drug)
Clopidogrel 75 mg od for 30 ± 5 days

Eligibility criteria

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

Conditions

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

Locations

University of Florida Health — Jacksonville, Florida, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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