Fixed Dose Combination Therapy for Secondary Prevention of Major Cardiovascular Events: Review of Literature and Design for Persian Polypill, A Randomized Clinical Trial.

This is a review on clinical trials assessing polypill in secondary prevention of cardiovascular diseases (CVD), followed by design of Persian Polypill study. We identified six completed studies and three ongoing trials having at least 10% of their participants with established CVD. Evaluation of these trials showed insufficient data to support polypill as a strategy to reduce major adverse cardiovascular events (MACE) in CVD patients, and a lack of studies in low and middle income countries. Persian Polypill will be an open labeled, parallel two arm, randomized clinical trial conducting on patients hospitalized because of an acute myocardial infarction (AMI). It is planned to randomize 1200 patients to one of the two arms, either receiving polypill or usual care and follow them for 34 months. The primary outcome will be a composite clinical outcome of MACE and the secondary outcome will be cost-effectiveness of polypill treatment. Results of this study might support comprising polypill in routine management of AMI, especially in developing countries.