Status:
COMPLETED
Stroke Minimization Through Additive Anti-atherosclerotic Agents in Routine Treatment
Lead Sponsor:
Northern California Institute of Research and Education
Collaborating Sponsors:
Kwame Nkrumah University Teaching Hospital
Conditions:
Atherosclerosis
Adherence, Medication
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
The overarching objective of the Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment (SMAART) trial is to assess whether a polypill containing fixed doses of (2/3) an...
Eligibility Criteria
Inclusion
- Above the age of 18 years; male or female
- Stroke/TIA 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 anti-hypertensive 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 :
February 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2022
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03329599
Start Date
February 14 2019
End Date
March 30 2022
Last Update
December 20 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kwame Nkrumah University of Science & Technology
Kumasi, Ghana