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RECRUITING
NCT06821191
PHASE4

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

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2025-03-10

Completion Date

2027-01-07

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

DRUG

clopidogrel 75 mg

Clopidogrel 75 mg od for 30 ± 5 days

DRUG

Prasugrel 5 mg

Prasugrel 5 mg od for 30 ± 5 days

Locations (1)

University of Florida

Jacksonville, Florida, United States