University of Florida
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.
The combination of low-dose aspirin and a P2Y12 receptor inhibitor, commonly referred as dual antiplatelet therapy (DAPT), is guideline-recommended for preventing atherothrombotic events in patients experiencing an acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI). In ACS patients undergoing PCI, DAPT is initiated at the time of the event and maintained for up to one year to mitigate the risks of stent-related complications and ischemic recurrences.4 There are 3 currently available oral P2Y12 inhibitors: clopidogrel, prasugrel, and ticagrelor. Among ACS patie…
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 cerebrovascul…
Clopidogrel 75 mg od for 30 ± 5 days
Prasugrel 5 mg od for 30 ± 5 days
Arctuva estimate
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