A Polypill for Acute Coronary Syndrome
Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial
University of Texas Southwestern Medical Center
1,000 participants
Dec 5, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Age ≥ 18
- Hospitalization for acute coronary syndrome with percutaneous coronary intervention
- Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin
Exclusion Criteria7
- Current need for systemic anticoagulation
- Contraindication to receive any components of the polypill
- History of allergic reaction or intolerance to aspirin, prasugrel or clopidogrel, or rosuvastatin
- Comorbidities that might be expected to limit lifespan within the 12-month study period
- Increased risk of bleeding or planned urgent surgery that would necessitate use of DAPT for \< 12 months
- Inability to provide written informed consent
- Pregnancy
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Interventions
The polypill is an inert capsule designed to combine multiple individual medications into a convenient, once-daily pill. In this case it will include DAPT and a statin.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07032389