Clinical Trial

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

Recruiting Phase 3
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Summary
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 1000 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.
Protocol Amendment History 5 changes
critical Recruitment opened 2026-07-07
notable Trial sites expanded: 1 -> 4 locations 2026-07-07
notable Primary completion pushed: 2028-07-01 -> 2029-01-31 2026-07-07
minor Completion pushed: 2028-09-01 -> 2029-02-01 2026-07-07
notable Enrollment increased: 680 -> 1000 participants 2026-06-23
Trial Details
NCT Number NCT05963568
Lead Sponsor Northern California Institute of Research and Education
Conditions Stroke, Medication Adherence
Enrollment 1,000 participants
Start Date 2026-04-01
Primary Completion 2029-01-31 (estimated)
Study Completion 2029-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06