NCT05963568 Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
| NCT ID | NCT05963568 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Northern California Institute of Research and Education |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,000 participants in total. It began in 2026-04-01 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05963568 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05963568 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,000 participants.
Is NCT05963568 currently recruiting?
Yes, NCT05963568 is actively recruiting participants. Contact the research team at bruce.ovbiagele@va.gov for enrollment information.
Where is the NCT05963568 trial being conducted?
This trial is being conducted at Parakou, Benin, Kumasi, Ghana, Ilorin, Nigeria, Dar es Salaam, Tanzania.
Who is sponsoring the NCT05963568 clinical trial?
NCT05963568 is sponsored by Northern California Institute of Research and Education. The trial plans to enroll 1,000 participants.
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