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NCT Number: NCT07025148

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)

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Florida Health

Jacksonville, Florida, 32209, United States

Location status: Recruiting

Location contact

Luis Ortega-Paz, MD, PhD

CONTACT

[email protected]

904-244-2060

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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].

Treatment and study plan

Prasugrel

Drug

Prasugrel 5 mg od for 30 ± 5 days

clopidogrel

Drug

Clopidogrel 75 mg od for 30 ± 5 days

Primary outcomes

  1. Platelet reactivity measured as PRU

    Time frame: 30 Day

    The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system in patients at dual-risk (both HBR and HIR [ABCD-GENE score ≥10 points]) between low-dose prasugrel (5 mg qd) vs. standard-dose clopidogrel (75 mg qd)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Burton, MPH, CCRP

CONTACT

[email protected]

904-244-5617

Luis Ortega-Paz, MD, PhD

CONTACT

[email protected]

904-244 2060

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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