Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (S… (NCT05963568) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Ghana1,000 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Severe congestive cardiac failure (NYHA III-IV)
* Severe renal disease, eGFR \<30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
* Cancer diagnosis or treatment in past 2 years
* Need for oral anticoagulation at the time of randomization or planned in the future months;
* Significant arrhythmias (including unresolved ventricular arrhythmias or atrial fibrillation)
* Nursing/pregnant mothers
* Do not agree to the filing, forwarding and use of his/her pseudonymized data.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite vascular risk factor control
Timeframe: 12 and 24 months
Trial details
NCT IDNCT05963568
SponsorNorthern California Institute of Research and Education