Switching from clopidogrel to low-dose prasugrel after PCI in people at high bleeding and ischemic risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized pharmacodynamic Phase 4 study comparing continuation of standard-dose clopidogrel versus switching to low-dose prasugrel in patients judged to be at both high bleeding risk (ARC-HBR) and high ischemic risk (ABCD-GENE score ≥10) after PCI. All participants are on maintenance dual antiplatelet therapy with aspirin 81 mg plus clopidogrel 75 mg daily for at least 30 days before randomization. The primary outcome is platelet reactivity measurements to determine whether switching improves platelet inhibition. The study is conducted at University of Florida Health in Jacksonville and enrolls adults who can give informed consent.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Florida Health
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Luis Ortega-Paz, MD, PhD — University of Florida College of Medicine - Jacksonville
• Study coordinator: Luis Ortega-Paz, MD, PhD
• Email: Luis.Ortega@jax.ufl.edu
• Phone: 904-244 2060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.