The overall objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment II (SMAART-II) is to deploy a hybrid study design to firstly, demonstrate the efficacy of a polypill (Polycap ®) containing fixed doses of antihypertensives, a statin, and antiplatelet therapy taken as two capsules, once daily orally in reducing composite vascular risk over 24 months vs. usual care among 1000 recent stroke patients encountered at 12 hospitals in Ghana. Secondly, SMAART II seeks to develop an implementation strategy for routine integration and policy adoption of this polypill for post-stroke cardiovascular risk reduction in an under-resourced system burdened by suboptimal care and outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
1,000
Patients allocated to the experimental arm will receive Two (2) (Polycap ®) taken orally once a day. A capsule of Polycap ® contains 100mg of Aspirin, 20mg of simvastatin, 12.5mg hydrochlorothiazide, 5mg of ramipril and 50mg of atenolol. Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment.
University Teaching Hospital of Parakou
Parakou, Benin
RECRUITINGKwame Nkrumah Institute of Science & Technology
Kumasi, Ghana
ACTIVE_NOT_RECRUITINGUniversity of Ilorin Teaching Hospital
Ilorin, Nigeria
RECRUITINGAga Khan Hospital
Dar es Salaam, Tanzania
NOT_YET_RECRUITINGComposite vascular risk factor control
Proportion of people who have 0, 1, 2 and 3 of the following: systolic BP \<140 mm Hg, LDL-cholesterol \<100mg/dl, antiplatelet adherence by pill count \>90%) at month 12 and month 24 (sustainment of effect)
Time frame: 12 and 24 months
Major adverse cardiovascular events (MACE)
MACE to be assessed include recurrent stroke: fatal/severely disabling stroke or non-fatal stroke; coronary artery disease: acute STEMI/NSTEMI, sudden cardiac deaths. MACE will be confirmed by a blinded adjudication committee by reviewing available clinical notes supported by investigations for example CT scans, EKGs, troponin tests, death certificates or verbal autopsy if death occurs outside hospital.
Time frame: 24 months
Change in adherence to medical therapy
Time frame: Month 3, 6, 9, 12, 18 & 24
Safety and tolerability
Side effects, adverse events, treatment withdrawal
Time frame: Up to 24 months
Health-related quality of life EuroQol-5D
EuroQol-5D questionnaire (0-100 with 100 being the best)
Time frame: Up to 24 months
Health-related quality of life Neuro-QoLTM
NINDS Neuro-QoLTM (Quality of Life in Neurological Disorders) questionnaires (8-40 with 40 being the best)
Time frame: Up to 24 months
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