Phase 2 N=148 Randomized Quadruple-blind Treatment

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Atherosclerosis · Adherence, Medication · Tolerance

Bottom Line

View on ClinicalTrials.gov: NCT03329599 ↗

Enrolled (actual)

148

Serious AEs

2.0%

Results posted

Dec 2023

Primary outcome: Primary: Carotid Intimal Media Thickness — -0.017; -0.092 mm

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Polycap (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northern California Institute of Research and Education
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Carotid Intimal Media Thickness	-0.017; -0.092	—
SECONDARY Morisky Adherence Scale Score	-0.19; -0.14	—
SECONDARY Hill-Bone Score	-0.51; -1.11	—
SECONDARY EQ-5D Quality-of-Life Score	7.63; 10.23	—
SECONDARY Treatment Satisfaction Questionnaire for Medication Score	-10.92; -6.72	—
SECONDARY Montreal Cognitive Assessment Score	5.17; 5.39	—
SECONDARY Modified Rankin Score	-0.92; -0.89	—
SECONDARY Hamilton Rating Scale for Depression Score	-3.51; -4.06	—

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.

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT03329599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.