BACKGROUND: There is an unprecedented rise in the prevalence of stroke in 
sub-Saharan Africa (SSA). 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. However, these goals are seldom realized in routine 
clinical care settings in SSA due to logistical challenges. 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).
METHODS: 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. Using a 
computer-generated sequence, patients will be randomly allocated 1:1 into either 
the intervention arm or UC. 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. 
Patients in the UC will receive separate, individual secondary preventive 
medications prescribed at the physician's discretion. 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. Secondary 
outcome measures include adherence to therapy, safety and tolerability, 
health-related quality of life, patient satisfaction, functional status, 
depression and cognitive dysfunction.
DISCUSSION: An 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.
TRIAL REGISTRATION: ClinicalTrials.gov , ID: NCT03329599 . Registered on 11 
February 2017.