Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Condition: Atherosclerosis; Adherence, Medication; Tolerance
MeSH terms: Atherosclerosis
Intervention: Polycap
Intervention 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

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.