Comparing two methods of reducing antiplatelet therapy in heart patients

Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study

This study is testing two ways to safely lower blood-thinning medication in heart patients after a procedure to see if one method works just as well as the other.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Florida (other)
• Locations: 1 site (Jacksonville, Florida)
• Trial ID: NCT06821191 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone PCI and are currently on DAPT treatment.

Not a fit: Patients with a history of stent thrombosis, recent PCI, or those on anticoagulant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help reduce bleeding risks for patients while still effectively preventing heart-related events.

How similar studies have performed: While there have been various studies on DAPT de-escalation, this specific head-to-head comparison is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Jacksonville, Florida

• University of Florida — Jacksonville, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Luis Ortega, MD, PhD

Conditions: Coronary Artery Disease, Coronary artery disease, DAPT de-escalation, DAPT, dose-reduction, switch, clopidogrel, prasugrel