Taking people in NigeriaPhase 3

Tests a combined daily pill to prevent further strokes in Ghana

Tests a once-daily combination pill in adults who recently had a stroke.

Key facts

Who runs it: Northern California Institute of Research and Education
Where: Ilorin, NigeriaSee the siteAlso in 3 other countries, 3 sites
Trial code: NCT05963568
Registry title: Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Status: Recruiting
Phase: Phase 3
People taking part: 1,000 people, planned
Started: 1 Apr 2026
Expected to end: 1 Feb 2029
Type of study: Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested: Polycap
Record updated: 6 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in Ghana who had an ischemic stroke in the last two months and also have diabetes, high blood pressure, mild to moderate kidney problems, or a past heart attack.

Age: Above 18 years, up to 100 years
Sex: Men and women can join
Disease stage: Ischemic stroke diagnosed no more than two months before joining. Lacunar, large-vessel atherosclerotic and cardio-embolic types can join. They must also have at least one of: diabetes, high blood pressure above 140/90mmHg or treatment for it, mild to moderate kidney problems (eGFR 60-30ml/min/1.73m2), or a past heart attack.
Earlier treatment: No specific prior treatment is required. People who need oral anticoagulation now or in the coming months cannot join.

Main reasons for not taking part

Bleeding stroke (hemorrhagic stroke)
Severe kidney disease (eGFR below 30ml/min/1.73m2), dialysis, awaiting a kidney transplant, or a transplant recipient
Severe heart failure (NYHA III-IV) or significant heart rhythm problems
Cancer diagnosis or treatment in the past 2 years
Pregnant or nursing mothers

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

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?

Where in Nigeria

Also in 3 other countries, 3 sites

University of Ilorin Teaching HospitalIlorin, NigeriaContact: Kolawole WahabTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

InterventionTreatment being tested
Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn \& replaced with the Polypill if they are already receiving such treatments before enrollment.
Treatment: Polycap
Control armNo study treatment, for comparison
Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention with drugs and doses left at the discretion of the treating physicians. Since our focus is to isolate the effect of the polypill strategy itself \& create equipoise, at study inception providers for patients in both study arms will receive a brief one-time (Skype-based) training \& a one time email synopsis on guideline recommended biomarker targets after stroke.