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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Atherosclerosis Clinical Trial

Official title:
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03329599
Study type Interventional
Source Northern California Institute of Research and Education
Contact
Status Completed
Phase Phase 2
Start date February 14, 2019
Completion date March 30, 2022
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