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

• Status: Not yet recruiting
• Trial end date: 2029-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northern California Institute of Research and Education

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.