Testing a Daily Polypill Combining Aspirin, P2Y12 Inhibitors, and Statins for Patients After Acute Coronary Syndrome with PCI A Multicenter Randomized Phase 2 Trial

What this Trial Is About

Researchers are evaluating a polypill strategy combining standard medications prescribed after acute coronary syndrome ACS into a single pill to improve treatment adherence and outcomes. ACS, including conditions like STEMI, NSTEMI, and unstable angina, remains a significant cause of illness and death in the U.S., with high risks of complications and death shortly after an ACS event. The study addresses critical gaps in medication adherence that contribute to adverse events post-ACS, especially among under-represented minorities and socioeconomically disadvantaged groups. The study compares a polypill containing aspirin 81 mg, a high-intensity statin rosuvastatin 40 or 10 mg, and a P2Y12 inhibitor prasugrel 10 mg or clopidogrel 75 mg to usual care where these medications are given as separate pills. This pragmatic, open-label, multicenter randomized trial assesses the feasibility and effectiveness of the polypill strategy for managing patients after ACS treated with percutaneous coronary intervention PCI. Participants in the usual care group will continue with standard individual pills of dual antiplatelet therapy DAPT and statins. Participants will be involved for at least six months, during which medication adherence, treatment satisfaction, and clinical outcomes are closely monitored. The primary outcome is assessed using a win ratio at six months, alongside secondary measures of adherence and satisfaction. The trial includes multiple visits to evaluate medication use and clinical status, with safety and treatment effects observed over this period. The study is sponsored by the University of Texas Southwestern Medical Center and aims to provide insight into improving care after ACS events.

A Polypill for Acute Coronary Syndrome