Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment

Northern California Institute of Research and Education (NCIRE)

Status and phase: Completed; Phase 2

Conditions: Adherence, Medication; Tolerance; Atherosclerosis

Treatments: Drug: Polycap

Study type: Interventional

Funder types: Other

Identifiers

NCT03329599

Pro00068785

Details and patient eligibility

About

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.

Enrollment: 148 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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148 participants in 2 patient groups

Polypill

Experimental group

Description:

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

Treatment:

Drug: Polycap

Usual Care

No Intervention group

Description:

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