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

Launched by NORTHERN CALIFORNIA INSTITUTE OF RESEARCH AND EDUCATION · Jul 19, 2023

Keywords

ClinConnect Summary

The SMAART II trial is studying a new treatment to help reduce the risk of future strokes in patients who have recently experienced an ischemic stroke, which is a type of stroke caused by a blockage in the blood vessels supplying the brain. The trial will test a special combination pill called Polycap®, which contains medications to lower blood pressure, cholesterol, and prevent blood clots. About 500 participants from 12 hospitals in Ghana will be involved in this study over a 24-month period. The goal is not only to see if this pill works better than standard care but also to find ways to make it a regular part of treatment for patients in areas where healthcare resources are limited.

To be eligible for this trial, participants need to be at least 18 years old and have had an ischemic stroke within the last two months. They should also have certain health conditions like high blood pressure, diabetes, or mild kidney issues. People who cannot give consent, have had a different type of stroke, or have certain serious health problems won’t be able to join. If you participate, you will take the Polycap® pill once a day and attend regular follow-up appointments to monitor your health. This trial is an important step in improving stroke care and could lead to better outcomes for many patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.