SMAART II Study Testing a Daily Polypill to Reduce Stroke-Related Vascular Risks Over 24 Months in Adults

What this Trial Is About

Researchers are evaluating the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II SMAART-II study, which aims to test a polypill strategy to reduce vascular risk in patients who recently experienced a stroke. This Phase 3 trial seeks to compare the effectiveness of a fixed-dose combination pill against usual care over 24 months, with a focus on improving cardiovascular outcomes in an under-resourced healthcare setting in Ghana. The study involves two groups one receiving the polypill Polycapae, which combines aspirin, simvastatin, hydrochlorothiazide, ramipril, and atenolol taken as two capsules once daily, and the other receiving standard care with treatments at the discretion of their doctors. Patients already on similar medications will have their treatments replaced by the polypill if assigned to that group. Both groups providers receive training on recommended biomarker targets for stroke secondary prevention. Participants will be monitored for up to 24 months, with regular assessments of vascular risk factor control, adherence to medical therapy, safety, and quality of life using specific health-related questionnaires. Researchers will track major adverse cardiovascular events and measure composite vascular risk at 12 and 24 months. The study includes safety and tolerability monitoring throughout the period and aims to develop strategies for integrating this treatment approach into routine care.

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)