Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) antihypertensives, a statin and antiplatelet therapy taken once daily orally would result in carotid intimal thickness regression-a surrogate marker of atherosclerosis, improved adherence, and tolerability compared with 'usual care' group on separate individual secondary preventive medications among Ghanaian first time stroke survivors. Our ultimate objective is to design of a future multi center, double-blinded, placebo-controlled, parallel-group, randomized trial comparing the clinical efficacy of the polypill strategy vs 'usual care' in the African context to derive locally relevant, high-quality evidence for routine deployment of polypill for CVD risk moderation among stroke survivors in LMICs. In this current study, we plan to recruit 120 recent ischemic stroke survivors randomized 1:1 to the polypill or usual care arms.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina; Northern California Institute of Research and Education
• Collaborator: Kwame Nkrumah University Teaching Hospital

Criteria

Inclusion Criteria:

• Above the age of 18 years; male or female

• Stroke/TIA 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 anti-hypertensive 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.