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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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)

NCT07025148•University of Florida

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

University of Florida Health

Jacksonville, Florida, United States

Key Dates

Start Date

October 1, 2025

Primary Completion Date

August 1, 2027

Completion Date

November 1, 2027

Last Updated

November 4, 2025

Enrollment

ESTIMATED participants

Conditions

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

Interventions

Prasugrel

DRUG

Clopidogrel

DRUG

Contacts

Luis Ortega-Paz, MD, PhD

CONTACT

904-244 2060 Luis.Ortega@jax.ufl.edu

Andrea Burton, MPH, CCRP

CONTACT

904-244-5617 Andrea.Burton@jax.ufl.edu

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Coronary Arterial Disease (CAD)NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)

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