At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years
- ✓Ischemic stroke or TIA diagnosis within 2 months of enrollment, including lacunar, large-vessel atherosclerotic, and cardioembolic subtypes
- ✓At least one of: documented diabetes mellitus, prior treatment with antihypertensive medications, hypertension >140/90 mmHg, mild-moderate renal dysfunction (eGFR 60-30 mL/min/1.73m²), or prior myocardial infarction
- ✓Legally competent to sign informed consent
- ✕Hemorrhagic stroke
- ✕Contraindications to any component of the polypill
- ✕Severe cognitive impairment/dementia or severe global disability limiting self-care capacity
- ✕Severe congestive cardiac failure (NYHA III-IV)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
In Brief
A Phase 2 clinical trial evaluating Polycap for Atherosclerosis and 2 related conditions. Completed, enrolled 148 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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