Polypill strategy for the treatment of patients after acute coronary syndromes - A multicenter randomized controlled trial

Acute coronary syndrome (ACS) is common and a cause of significant morbidity and mortality worldwide. ACS is treated routinely with percutaneous intervention followed by dual antiplatelet therapy and high-intensity lipid- lowering statin therapy for 12 months. The post-ACS period is highly vulnerable, and rates of morbidity and mortality remain high despite the availability of effective treatments. Non-adherence to post-discharge medications is a major preventable cause of morbidity and mortality in the post-ACS period. Moreover, adverse outcomes and non-adherence rates are higher among individuals from low-income groups and among racial/ethnic minorities. The polypill strategy has shown promise in improving adherence to medications and reducing cardiovascular risk in primary and secondary prevention settings. Nonetheless, polypill-based strategies have not been evaluated for individuals in the vulnerable post-ACS period, when adherence to dual antiplatelet therapy and high-intensity statins is particularly critical. Furthermore, optimal strategies for the implementation of a polypill approach and its acceptance in the clinical community by different stakeholders are not known. To address this knowledge gap, we propose a type 1 hybrid effectiveness-implementation, multi-center, randomized trial to test the feasibility and effectiveness of a polypill-based strategy for post-ACS management. We will utilize a flexible polypill containing a high-intensity statin, aspirin, and P2Y12 inhibitor. The once-daily polypill will be added to baseline medical therapy. The primary endpoint will be composite clinical outcomes, including all-cause mortality, ischemic events, and bleeding events over 12 months. Additionally, we will evaluate the polypill acceptability, preferences, cost, and lessons among providers and patients. Project Number: 1R01HL173838-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Heart Lung and Blood Institute (NHLBI) | Principal Investigator: Ambarish Pandey (+1 co-PI) | Institution: UT SOUTHWESTERN MEDICAL CENTER, DALLAS, TX | Award Amount: $730,276 | Activity Code: R01 | Study Section: Cardiovascular and Respiratory Diseases Study Section[CRD] View on NIH RePORTER: https://reporter.nih.gov/project-details/1R01HL17383801A1