Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Summary

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.

Timeline

Start

2019-02-14

Primary completion

2021-12-01

Completion

2022-03-30

Publications

• Sarfo FS, Adu-Gyamfi R, Opare-Addo PA, Agyei B, Ampofo M, Nguah SB, Ovbiagele B. Effect of a Cardiovascular Polypill on Poststroke Cognition Among Ghanaians: Secondary Analysis of a Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e034346. doi: 10.1161/JAHA.124.034346. Epub 2024 Jul 31.
• Sarfo FS, Voeks J, Adamu S, Agyei BA, Agbenorku M, Adu-Darko N, Oteng MA, Obese V, Gyamfi RA, Mensah NA, Tagge R, Ampofo M, Kontoh SA, Nguah SB, Ovbiagele B. A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial. Lancet Glob Health. 2023 Oct;11(10):e1619-e1628. doi: 10.1016/S2214-109X(23)00347-9.
• Sarfo FS, Sarfo-Kantanka O, Adamu S, Obese V, Voeks J, Tagge R, Sethi V, Ovbiagele B. Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial. Trials. 2018 Mar 14;19(1):181. doi: 10.1186/s13063-018-2564-0.

Drugs

Indications