Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The current study aims to investigate whether combining the standard medications prescribed after acute coronary syndrome (ACS)-aspirin, P2Y12 inhibitors, and statins-into a single polypill can improve outcomes following an ACS event. Although these therapies are effective, gaps in adherence and uptake significantly contribute to risk or adverse events in the post-ACS period. This study is designed as a pragmatic, multi-center, randomized trial to assess the feasibility and effectiveness of a polypill-based strategy for treatment of ACS.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18
• Hospitalization for acute coronary syndrome with percutaneous coronary intervention
• Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin
Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Time Frame
Start Date: 2025-12-05
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 1000
Treatments
Experimental: Polypill
The polypill combines DAPT and a high intensity statin: (a) aspirin 81 mg, (b) rosuvastatin (40 or 10 mg) and (c) prasugrel 10 mg or clopidogrel 75 mg.
No_intervention: Usual care
Participants in the usual care arm will be prescribed DAPT and statins as standard therapy in individual pills.
Related Therapeutic Areas
Sponsors
Leads: University of Texas Southwestern Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)