Tests a combined daily pill to prevent further strokes in Ghana
Tests a once-daily combination pill in adults who recently had a stroke.
Plain-language title generated from the registry record
Registry title: Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Key facts
- Where
- Parakou, BeninSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Source: NCT05963568, who can take part
Where in Benin
- University Teaching Hospital of ParakouParakou, BeninTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northern California Institute of Research and Education
- Trial code
- NCT05963568
- Record updated
- 6 July 2026
- Original description
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.Read full original descriptionShow less
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
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.
Inclusion: 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; Subjects with stroke may present with at least one of the following additional conditions:; Documented diabetes mellitus or previous treatment with oral hypoglycemic or insulin; documented hypertension >140/90mmHg or previous treatment with antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction; Legally competent to sign informed consent.
Exclusion: Hemorrhagic stroke; Severe cognitive impairment/dementia or severe global disability limiting the capacity of self-care; Severe congestive cardiac failure (NYHA III-IV); Cancer diagnosis or treatment in past 2 years; Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation); Severe renal disease, eGFR <30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient; Unable to sign informed consent; Contraindications to any of the components of the polypill; Need for oral anticoagulation at the time of randomization or planned in the future months; Nursing/pregnant mothers; Do not agree to the filing, forwarding and use of his/her pseudonymized data.