NCT05963568RecruitingPhase 3
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 11 Aug 2022
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Northern California Institute of Research and Education
- Diseases
- Stroke
- NCT number
- NCT05963568
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1000
- From 1 Apr 2026 to the primary completion date, 31 Jan 2029
- 4 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- Severe renal disease, eGFR \<30ml/min/1.73m2), renal dialysis; awaiting renal transplant or transplant recipient
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Teaching Hospital of Parakou Coordinator of this site? Confirm its status | Parakou | Benin | Recruiting |
| Kwame Nkrumah Institute of Science & Technology Coordinator of this site? Confirm its status | Kumasi | Ghana | Active, not recruiting |
| University of Ilorin Teaching Hospital Coordinator of this site? Confirm its status | Ilorin | Nigeria | Recruiting |
| Aga Khan Hospital Coordinator of this site? Confirm its status | Dar es Salaam | Tanzania | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.