Interventional Recruiting Phase 3
NCT05963568 on ClinicalTrials.gov
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
- Sponsor: Northern California Institute of Research and Education
- Enrollment: 1000 (Estimated)
- Study start: 2026-04-01 (Actual)
- Primary completion: 2029-01-31 (Estimated)
- Study completion: 2029-02-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Single (Outcomes Assessor)
- PrimaryPurpose: Prevention
Brief Summary
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.
Conditions
- Stroke
- Medication Adherence
Intervention / Treatment
- Drug: Polycap
Primary Outcome Measures
-
Composite vascular risk factor control
(12 and 24 months)
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)
Countries
Benin, Ghana, Nigeria, Tanzania
Locations and Investigators
-
University Teaching Hospital of Parakou, Parakou, Benin (Recruiting)
- Thierry Adokounou
- Kwame Nkrumah Institute of Science & Technology, Kumasi, Ghana (Active not recruiting)
- University of Ilorin Teaching Hospital, Ilorin, Nigeria (Recruiting)
-
Aga Khan Hospital, Dar es Salaam, Tanzania (Not yet recruiting)
- Sarah Matuja