Status:
NOT_YET_RECRUITING
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment II Study (SMAART II)
Lead Sponsor:
Northern California Institute of Research and Education
Conditions:
Stroke
Medication Adherence
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 efficac...
Eligibility Criteria
Inclusion
- 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
- 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 antihypertensive medications; Mild to moderate renal dysfunction (eGFR 60-30ml/min/1.73m2); Prior myocardial infarction
- Legally competent to sign informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
680 Patients enrolled
Trial Details
Trial ID
NCT05963568
Start Date
January 1 2026
End Date
September 1 2028
Last Update
December 4 2025
Active Locations (1)
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1
Kwame Nkrumah Institute of Science & Technology
Kumasi, Ghana