Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Status:
Active, not recruiting
Trial end date:
2021-11-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Medical University of South Carolina Northern California Institute of Research and Education