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RECRUITING
NCT05963568
PHASE3

Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)

Sponsor: Northern California Institute of Research and Education

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2026-04-01

Completion Date

2029-02-01

Last Updated

2026-07-06

Healthy Volunteers

No

Interventions

DRUG

Polycap

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 Patients assigned to Polypill will have their antihypertensive agents, lipid modifiers and anti-thrombotic agents withdrawn and replaced with the Polypill if they are already receiving such treatments before enrollment.

Locations (4)

University Teaching Hospital of Parakou

Parakou, Benin

Kwame Nkrumah Institute of Science & Technology

Kumasi, Ghana

University of Ilorin Teaching Hospital

Ilorin, Nigeria

Aga Khan Hospital

Dar es Salaam, Tanzania