Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

NCT03329599 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00068785
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atherosclerosis; Adherence, Medication; Tolerance

Outcome Measures

Primary Outcomes (1)

• Carotid Intimal Media Thickness

  Thickness of the intima and media layers of the carotid arteries

  Baseline and 12 months

Secondary Outcomes (7)

• Morisky Adherence Scale Score

  12 months

• Hill-Bone Score

  12 months

• EQ-5D Quality-of-Life Score

  12 months

• Treatment Satisfaction Questionnaire for Medication Score

  12 months

• Montreal Cognitive Assessment Score

  12 months

Study Arms (2)

Polypill

EXPERIMENTAL

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

Drug: Polycap

Usual Care

NO INTERVENTION

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

Interventions

Polycap 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

Polypill

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern California Institute of Research and Education: lead
• Kwame Nkrumah University Teaching Hospital: collaborator

Study Sites (1)

Kwame Nkrumah University of Science & Technology

Kumasi, Ghana

Location

Related Publications (3)

• 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.

  PMID: 39082406 DERIVED

• 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.

  PMID: 37734804 DERIVED

• 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.

  PMID: 29540234 DERIVED

MeSH Terms

Conditions

Atherosclerosis; Medication Adherence

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Limitations and Caveats

Study was conducted in a single tertiary medical centre, limiting its generalisability; The inter-rater agreement between the two independent CIMT readings per participants by the sonographers using a post-hoc intracluster correlation coefficient was fair; Future trials should be powered to assess treatment effects by stroke subtypes; Implementation of outcome measures must be performed to assess the barriers and facilitators associated with uptake.

Results Point of Contact

• Title: Bruce Ovbiagele
• Organization: Northern California Institute for Research & Education

bruce.ovbiagele@va.gov

415-750-2047

Study Officials

• Jenifer Voeks, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Neurology

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: November 6, 2017
• Study Start: February 14, 2019
• Primary Completion: December 1, 2021
• Study Completion: March 30, 2022
• Last Updated: December 20, 2023
• Results First Posted: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)