CiLostAzol for pReventIon of Recurrent sTroke in Africa

Launched by NORTHERN CALIFORNIA INSTITUTE OF RESEARCH AND EDUCATION · Apr 2, 2025

Keywords

ClinConnect Summary

The CiLostAzol for pReventIon of Recurrent sTroke in Africa (CLARITY-AFRICA) trial is studying a medication called cilostazol to see if it can help prevent strokes from happening again in patients who have recently had a stroke. This trial is particularly important because stroke survival rates in sub-Saharan Africa are very low, with many patients experiencing serious health problems afterward. The study will include about 1,100 patients from 12 hospitals in Ghana who are over 30 years old and have had an ischemic stroke or a high-risk mini-stroke within the past six months. Participants must be taking aspirin or clopidogrel, which are common medications used to prevent blood clots.

If you or someone you know qualifies for this study, you can expect to take cilostazol or a placebo (a pill with no active medication) twice a day for 24 months. Throughout the study, participants will have regular check-ups to monitor their health. The goal is not only to see if cilostazol is effective but also to gather information that could help improve stroke care in Africa. This trial aims to provide valuable insights that may lead to better prevention strategies for strokes in the future, benefiting many patients in the region.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Above the age of 30 years; male or female (sex is a biological variable of interest)
• • 2. Ischemic stroke or high-risk TIA (ABCD2 score \>= 6) diagnosis no greater than six months before enrollment. Ischemic strokes including lacunar, large vessel atherosclerotic, embolic stroke of undetermined source subtypes are eligible (Ischemic stroke or TIA should be confirmed by either with a cranial CT or MRI within 10 days of symptom onset)
• • 3. Aspirin or clopidogrel monotherapy
• • 4. Subjects with stroke may present with two or more of the following additional conditions: age ≥65 years, 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
• • 5. Legally competent to sign informed consent or have a LARs who is able to provide consent for them
• • 6. In the opinion of the treating physician, patient is medically stable, capable of participating in a randomized trial, and willing and able to attend follow-up.
• • 7. Able to do labs at all study intervals (7 visits total)
• Exclusion Criteria:
• • 1. Unable to provide a valid informed consent
• • 2. Contraindications to cilostazol (namely (i) hypersensitivity, (ii) active pathologic bleeding, e.g. bleeding peptic ulcer, intracranial bleeding due to reversible platelet aggregation, (iii) congestive cardiac failure.)
• • 3. Hemorrhagic stroke survivor within the last 2 years
• • 4. Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)
• • 5. On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)
• • 6. Modified Rankin Scale 5
• • 7. Thrombocytopenia (platelet count \<1000,000)
• • 8. Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)
• • 9. Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity)
• • 10. Nursing/pregnant mothers