Recruiting

Prasugrel vs. Clopidogrel

Sponsor:

University of Florida

Code:

NCT07025148

Conditions

Coronary Arterial Disease (CAD)

Percutaneous Coronary Intervention (PCI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prasugrel

Clopidogrel

Study Details

Brief 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.

Conditions

Coronary Arterial Disease (CAD)

Percutaneous Coronary Intervention (PCI)

Study ID

NCT07025148

Start date

Oct 1, 2025

Status verified date

Aug, 2025

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dual risk - Clopidogrel-based DAPT

Patients deemed at high risk for both bleeding and ischemic risk randomized to continue clopdiogrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.

experimental: Dual risk - Low-dose prasugrel-based DAPT

Patients deemed at high risk for both bleeding and ischemic risk randomized to receive low-dose prasugrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.

active comparator: Control

Patients deemed at high risk for both bleeding but not at high risk for ischemic events being actively treated with clopidogrel-based DAPT as per standard of care. High bleeding riks will be defined according to the Academic Research Consortium definition.

Interventions

Prasugrel

Prasugrel 5 mg od for 30 ± 5 days

Clopidogrel

Clopidogrel 75 mg od for 30 ± 5 days

Primary outcome measure

  • Platelet reactivity measured as PRU [ Time Frame: 30 Day ]

Central Contacts and Locations

Central contacts

Luis Ortega-Paz, MD, PhD

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

Andrea Burton, MPH, CCRP

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

Locations

University of Florida Health

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Luis Ortega-Paz, MD, PhD

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

More Information

Sponsor

University of Florida

Last update posted

Nov 4, 2025

Last verified

Aug, 2025

Keywords

  • Coronary artery disease
  • Dual antiplatelet therapy
  • High bleeding risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-11-04.