Polypill Strategy for the Treatment of Patients After Acute Coronary Syndromes - A Multicenter Randomized Controlled Trial
University of Texas Southwestern Medical Center
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.
Description
Acute coronary syndrome (ACS) poses a major public health challenge in the United States. ACS, a constellation of acute cardiovascular conditions including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), and unstable angina, is a major determinant of morbidity and mortality across the United States. An American will suffer from an ACS event every 40 seconds, and \~1 million individuals have an ACS event annually. The absolute 30-day and 1-year mortality rates following an ACS event have remained high over the past several years. Myoc…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 * Hospitalization for acute coronary syndrome with percutaneous coronary intervention * Discharged on aspirin, prasugrel or clopidogrel, and a high-intensity statin Exclusion Criteria: * 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 D…
Interventions
- Combination ProductPolypill
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.
Location
- University of Texas Southwestern Medical CenterDallas, Texas