#CHANGE SMAART V7 SAMPLE RATE TRIAL#
DiscussionĪn efficacy-suggesting SMAART trial could inform the future design of a multi-center, double-blinded, placebo-controlled, parallel-group, randomized controlled trial comparing the clinical efficacy of the polypill strategy for vascular risk moderation among stroke survivors in SSA. Secondary outcome measures include adherence to therapy, safety and tolerability, health-related quality of life, patient satisfaction, functional status, depression and cognitive dysfunction. Both groups will be followed for 12 months to assess changes in carotid intimal thickness regression – a surrogate marker of atherosclerosis – as primary outcome measure. Patients in the UC will receive separate, individual secondary preventive medications prescribed at the physician’s discretion. Patients in the intervention arm will receive Polycap DS® (containing aspirin, 100 mg atenolol, 50 mg ramipril, 5 mg thiazide, 12.5 mg simvastatin, 20 mg) taken as two capsules once daily.
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Using a computer-generated sequence, patients will be randomly allocated 1:1 into either the intervention arm or UC. The Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is a phase 2, open-label, evaluator-blinded trial involving 120 Ghanaian recent-ischemic-stroke survivors. We seek to assess whether a polypill containing fixed doses of three antihypertensive agents, a statin and antiplatelet therapy taken once daily per os for 12 months among recent stroke survivors would result in carotid intimal thickness regression compared with usual care (UC).
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However, these goals are seldom realized in routine clinical care settings in SSA due to logistical challenges. Secondary prevention guidelines recommend that antihypertensive, statin and antiplatelet therapy be initiated promptly after ischemic stroke and adhered to in a persistent fashion to achieve optimal vascular-risk reduction. There is an unprecedented rise in the prevalence of stroke in sub-Saharan Africa (SSA).