NCT03329599

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Northern California Institute of Research and Education · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atherosclerosis
• Adherence, Medication
• Tolerance

Interventions

Type	Name	Description
DRUG	Polycap	Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule

Timeline

• Start date: 2019-02-14
• Primary completion: 2021-12-01
• Completion: 2022-03-30
• First posted: 2017-11-06
• Last updated: 2023-12-20
• Results posted: 2023-12-20

Locations

1 site across 1 country: Ghana

Regulatory

• FDA-regulated drug study