COXs x β1-adrenergic receptor x ACE x HMGCR

The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 500 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.

Cardiovascular diseases (CVD) are the leading cause of mortality and morbidity worldwide. The most important aspect of CVD secondary prevention is adherence to guideline-indicated pharmacological therapy which globally remains low. In previous studies, a Polypill containing fixed dose combination of essential drugs have improved patient adherence to these drugs. The effect of such a strategy on pharmacological therapy uptake, cost-effectiveness, and CVD recurrence in our setting will be assessed in this study. Participants hospitalized in three referral hospitals in Isfahan, Iran because of an acute myocardial infarction (MI) (ST elevation MI (STEMI) or non-ST elevation MI (NSTEMI)) will be randomized to either receiving Polypill or usual care after MI. Patient recruitment will be carried out at the time of patient discharge from the hospitals.

The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.