Comparing two methods of reducing antiplatelet therapy in heart patients

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 clinical trial compares two strategies for de-escalating dual antiplatelet therapy (DAPT) in patients who have undergone percutaneous coronary intervention (PCI) for coronary artery disease. One group will receive a dose reduction of prasugrel to 5 mg, while the other will switch to clopidogrel at a standard dose of 75 mg. The study aims to determine if these two approaches are equally effective in maintaining ischemic protection while reducing the risk of bleeding. It is a non-inferiority trial, meaning it seeks to show that the new strategies are not worse than the current standard.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who have undergone PCI and are on maintenance treatment with DAPT, consisting of low-dose aspirin with either prasugrel (10 mg qd) or ticagrelor (90 mg bid) as part of standard of care. In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI.
2. Age ≥18 years.
3. Provide written informed consent.

Exclusion Criteria:

1. Prior history of stent thrombosis
2. Prior cerebrovascular event
3. PCI within 30 days
4. Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., \*2/\*2 or \*3/\*3),
5. 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)
6. Hemodynamic instability
7. Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel
8. Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL)
9. Known hemoglobinopathies or anemia (hemoglobin \<9 g/dL)
10. 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
  Jacksonville, Florida, United States Recruiting

Study contacts

• Study coordinator: Luis Ortega, 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.