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Recruiting NCT05963568

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)

Phase III Interventional Stroke Medication Adherence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polycap.
Who it may be relevant to
Registry conditions: Stroke, Medication Adherence. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Benin, Ghana, Nigeria, Tanzania
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Polycap
    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 Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment.

Primary outcome measures

  • Composite vascular risk factor control [Time frame: 12 and 24 months]
Secondary outcome measures (5)
  • Major adverse cardiovascular events (MACE) [Time frame: 24 months]
  • Change in adherence to medical therapy [Time frame: Month 3, 6, 9, 12, 18 & 24]
  • Safety and tolerability [Time frame: Up to 24 months]
  • Health-related quality of life EuroQol-5D [Time frame: Up to 24 months]
  • Health-related quality of life Neuro-QoLTM [Time frame: Up to 24 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Benin · 1 center
  • University Teaching Hospital of Parakou — Parakou
Ghana · 1 center
  • Kwame Nkrumah Institute of Science & Technology — Kumasi
Nigeria · 1 center
  • University of Ilorin Teaching Hospital — Ilorin
Tanzania · 1 center
  • Aga Khan Hospital — Dar es Salaam

Publications

  • Sarfo FS, Wahab K, Matuja SS, Adebayo PB, Adoukonou T, Tagge R, Ovbiagele B. Stroke minimization through additive anti-atherosclerotic agents in routine treatment (SMAART) II: Rationale for a multi-country polypill phase 3 trial in sub-Saharan Africa. Equity Neurosci. 2026 Apr;2(1):100020. doi: 10.1016/j.neuros.2026.100020. Epub 2026 Jan 22. PMID 41727852

Identifiers

NCT: NCT05963568 · 22-37310

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗