About this trial
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.
Eligibility criteria
Qualifiers
Above the age of 18 years; male or female
Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible
Legally competent to sign informed consent.
Disqualifiers
Unable to sign informed consent
Contraindications to any of the components of the polypill
Hemorrhagic stroke
Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care
Trial design
Treatments tested in this trial
- Polycap