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. 2018 Mar 14;19(1):181.
doi: 10.1186/s13063-018-2564-0.

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

Fred Stephen Sarfo  1   2 , Osei Sarfo-Kantanka  3 , Sheila Adamu  3 , Vida Obese  3 , Jennifer Voeks  4 , Raelle Tagge  4 , Vipin Sethi  5 , Bruce Ovbiagele  4
Affiliations

Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial

Fred Stephen Sarfo et al. Trials. .

Abstract

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.

Keywords: Carotid intima-media thickness; Low- and middle-income countries; Polypill; Secondary risk reduction; Stroke.

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Conflict of interest statement

Ethics approval and consent to participate

Ethical approval for the study was been obtained from The Committee of Human Research Publication and Ethics, KNUST, Ghana (reference number: CHRPE/AP/524/17) and the IRB at the Medical University of South Carolina, Charleston, SC, USA. Important protocol modifications will be sought from both ethics committees.

Informed consent: written informed consent will be obtained from all patients before enrollment by a trained research coordinator. Patients are free to withdraw at any time.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial algorithm
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure: SMAART trial protocol – schedule of enrollment, intervention and assessments
See this image and copyright information in PMC

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