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

Phase 3

Not yet recruiting

• Conditions: Medication Adherence; Stroke
• Interventions: Drug: Polycap

• Registration Number: NCT05963568
• Lead Sponsor: Northern California Institute of Research and Education

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 500 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-11
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Start: 2025-06-01
• Primary Completion: 2026-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 680

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	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 \& replaced with the Polypill if they are already receiving such treatments before enrollment.

Primary Outcome Measures

Name	Time	Method
Composite vascular risk factor control	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 Outcome Measures

Name	Time	Method
Change in adherence to medical therapy	Month 3, 6, 9, 12, 18 & 24
Health-related quality of life EuroQol-5D	Up to 24 months	EuroQol-5D questionnaire (0-100 with 100 being the best)
Major adverse cardiovascular events (MACE)	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.
Safety and tolerability	Up to 24 months	Side effects, adverse events, treatment withdrawal
Health-related quality of life Neuro-QoLTM	Up to 24 months	NINDS Neuro-QoLTM (Quality of Life in Neurological Disorders) questionnaires (8-40 with 40 being the best)

Trial Locations

Locations (1)

Kwame Nkrumah Institute of Science & Technology; 🇬🇭 Kumasi, Ghana