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NCT Number: NCT05963568

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Medication Adherence Nervous System Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Teaching Hospital of Parakou, Parakou, Benin

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polycap

Drug

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 outcomes

  1. Composite vascular risk factor control

    Time frame: 12 and 24 months

    Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP <140 mm Hg, LDL-cholesterol <100mg/dl, antiplatelet adherence by pill count >90%) at month 12 and month 24 (sustainment of effect)

Secondary outcomes

  1. Major adverse cardiovascular events (MACE)

    Time frame: 24 months

    MACE to be assessed include recurrent stroke: fatal/severely disabling stroke or non-fatal stroke; coronary artery disease: acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudication committee by reviewing available clinical notes supported by investigations for example CT scans, EKGs, troponin tests, death certificates or verbal autopsy if death occurs outside hospital.

  2. Change in adherence to medical therapy

    Time frame: Month 3, 6, 9, 12, 18 & 24

  3. Safety and tolerability

    Time frame: Up to 24 months

    Side effects, adverse events, treatment withdrawal

  4. Health-related quality of life EuroQol-5D

    Time frame: Up to 24 months

    EuroQol-5D questionnaire (0-100 with 100 being the best)

  5. Health-related quality of life Neuro-QoLTM

    Time frame: Up to 24 months

    NINDS Neuro-QoLTM (Quality of Life in Neurological Disorders) questionnaires (8-40 with 40 being the best)

Other outcomes

  1. Organizational Capacity for Change Score

    Time frame: Up to 30 months

    Adoption i.e. Organizational Capacity for Change (OCC Scale Score comparison) with stratification by level of healthcare delivery. The measure is a 32-item multidimensional scale that evaluates an organization's capacity to upgrade or revise existing organizational competencies, while cultivating new competencies that enable the organization to survive and prosper. It comprises different aspects of leadership, employee behavior, and an organizational infrastructure supporting organizational change. Items are rated on a 5-point Likert scale. OCC has a Cronbach α of 0.87.

  2. Mean Cost of Implementation

    Time frame: Up to 30 months

    Implementation Cost (mean monthly health expenses compared to standard of care)

  3. Proportion who achieves systolic blood pressure <140 mmHg

    Time frame: Months 12 and 24

  4. Proportion who achieves blood pressure <140/90 mmHg

    Time frame: Months 12 and 24

  5. Proportion who achieves blood pressure < 130 / 80 mmHg

    Time frame: Months 12 and 24

  6. Proportion who achieves LDL-cholesterol <100 mg/dl

    Time frame: Months 12 and 24

  7. Proportion who achieves LDL-cholesterol <70 mg/dl

    Time frame: Months 12 and 24

  8. Proportion who achieves antiplatelet adherence of at least >=80%

    Time frame: Months 12 and 24

  9. Proportion who achieves antiplatelet adherence of at least >= 90%

    Time frame: Months 12 and 24

  10. Comparison of absolute and mean changes from baseline for blood pressure

    Time frame: Up to 24 months

    systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, measures of visit-to-visit variability in blood pressure

  11. Comparison of absolute and mean changes from baseline for lipids

    Time frame: Up to 24 months

    Total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglyceride

  12. Proportion with recurrent strokes (fatal or non-fatal)

    Time frame: Up to 24 months

  13. Proportion with coronary artery disease

    Time frame: Up to 24 months

  14. Proportion with heart failure

    Time frame: Up to 24 months

  15. Proportion with cardiovascular deaths

    Time frame: Up to 24 months

  16. Proportion with all-cause mortality

    Time frame: Up to 24 months

  17. Proportion with vascular cognitive impairment

    Time frame: Months 12 and 24

  18. Proportion with treatment-limiting adverse drug reactions or side effects

    Time frame: Up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce Ovbiagele, MD

CONTACT

[email protected]

415-750-2047

Raelle Tagge, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Northern California Institute of Research and Education

Other

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 27, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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