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Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

NCT ID: NCT03329599

Last Updated: 2023-12-20

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-14

Study Completion Date

2022-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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Atherosclerosis Adherence, Medication Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SMAART incorporates (i) a pilot randomized controlled trial and (ii) a human capital/institutional capacity building component. We propose a randomized, open label, blinded endpoint clinical trial with the intervention arm assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule compared with the 'usual care' arm who will continue to take separate, individual secondary preventive medications as prescribed their physicians to assess CIMT changes as a robust intermediary outcome measure for CVD events, as well as adherence, tolerability, and risk factor control rates. Furthermore, a cadre of emerging investigators from Ghana will benefit from the rich learning environment to be created through the implementation of the RCT and the interactions (2 years) with experts from the Medical University of South Carolina.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Polypill

Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule

Group Type EXPERIMENTAL

Polycap

Intervention Type DRUG

Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule

Usual Care

Will continue to take separate, individual secondary preventive medications as prescribed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Polycap

Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kwame Nkrumah University Teaching Hospital

OTHER

Sponsor Role collaborator

Northern California Institute of Research and Education

OTHER

Sponsor Role lead

Responsible Party

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Bruce Ovbiagele

Chair, Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenifer Voeks, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Kwame Nkrumah University of Science & Technology

Kumasi, , Ghana

Site Status

Countries

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Ghana

References

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Sarfo FS, Adu-Gyamfi R, Opare-Addo PA, Agyei B, Ampofo M, Nguah SB, Ovbiagele B. Effect of a Cardiovascular Polypill on Poststroke Cognition Among Ghanaians: Secondary Analysis of a Randomized Clinical Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e034346. doi: 10.1161/JAHA.124.034346. Epub 2024 Jul 31.

Reference Type DERIVED
PMID: 39082406 (View on PubMed)

Sarfo FS, Voeks J, Adamu S, Agyei BA, Agbenorku M, Adu-Darko N, Oteng MA, Obese V, Gyamfi RA, Mensah NA, Tagge R, Ampofo M, Kontoh SA, Nguah SB, Ovbiagele B. A cardiovascular polypill for secondary stroke prevention in a tertiary centre in Ghana (SMAART): a phase 2 randomised clinical trial. Lancet Glob Health. 2023 Oct;11(10):e1619-e1628. doi: 10.1016/S2214-109X(23)00347-9.

Reference Type DERIVED
PMID: 37734804 (View on PubMed)

Sarfo FS, Sarfo-Kantanka O, Adamu S, Obese V, Voeks J, Tagge R, Sethi V, Ovbiagele B. Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART): study protocol for a randomized controlled trial. Trials. 2018 Mar 14;19(1):181. doi: 10.1186/s13063-018-2564-0.

Reference Type DERIVED
PMID: 29540234 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00068785

Identifier Type: -

Identifier Source: org_study_id