Antiplatelet Therapy Strategies for Coronary Artery Disease

(SWAP-8 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for patients with coronary artery disease who've had an acute event or a procedure to open their arteries. They must be on dual antiplatelet therapy but can't join if they have conditions that the study excludes, which aren't specified here.

Inclusion Criteria

Provide written informed consent.

I had a heart procedure, take specific heart medications, and it's been over 30 or 90 days since.

I am 18 years old or older.

Exclusion Criteria

Prior history of stent thrombosis

Prior cerebrovascular event

I had a heart procedure within the last 30 days.

Treatment Details

Interventions

• Clopidogrel (Antiplatelet)
• Prasugrel (Antiplatelet)

Trial Overview The study tests two ways to reduce bleeding risk in heart patients while protecting against clots: one group will take a lower dose of Prasugrel (5 mg), and another will switch to standard-dose Clopidogrel (75 mg). It's a head-to-head test to see if both methods are equally effective.

Participant Groups

Group I: DAPT de-escalation by dose-reduction Experimental Treatment 1 Intervention

Group II: DAPT de-escalation by switch Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Dr. Stephen J. Motew

University of Florida

Chief Executive Officer since 2024

MD cum laude from the University of Illinois at Chicago School of Medicine, Master's in Healthcare Administration from the University of North Carolina at Chapel Hill

Dr. Timothy E. Morey

University of Florida

Chief Medical Officer since 2023

MD and Bachelor's from the University of Florida