Actively Recruiting
Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study
Led by University of Florida · Updated on 2026-05-12
78
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.
CONDITIONS
Official Title
Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have undergone PCI and are on maintenance dual antiplatelet therapy with low-dose aspirin and either prasugrel (10 mg daily) or ticagrelor (90 mg twice daily) as standard care
- Patients with acute coronary syndrome who are at least 90 days post-PCI
- Patients with chronic coronary syndrome who are at least 30 days post-PCI
- Age 18 years or older
- Able to provide written informed consent
You will not qualify if you...
- History of stent thrombosis
- History of cerebrovascular event
- Percutaneous coronary intervention within the past 30 days
- Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., *2/*2 or *3/*3 alleles)
- Current treatment with any oral anticoagulant or chronic low-molecular-weight heparin (for venous thrombosis treatment)
- Hemodynamic instability
- Hypersensitivity to aspirin, clopidogrel, or prasugrel
- Known blood cancers or low platelet count (less than 80 x 10^6/mL)
- Known blood disorders or anemia (hemoglobin less than 9 g/dL)
- Pregnant or breastfeeding women (women of childbearing age must use reliable birth control during the study)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Jacksonville, Florida, United States, 32209
Actively Recruiting
Research Team
L
Luis Ortega, MD, PhD
CONTACT
A
Andrea Burton, MPH, CCRP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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