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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorNorthern California Institute of Research and Education

About this trial

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.

Eligibility criteria

Qualifiers

Above the age of 18 years; male or female

Ischemic stroke diagnosis no greater than two months before enrollment. Ischemic strokes including� lacunar, large-vessel atherosclerotic, cardio-embolic subtypes are eligible

Legally competent to sign informed consent.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Polycap

Treatment groups

1,000 Participants
are divided into 2 treatment groups