Status:
NOT_YET_RECRUITING
CiLostAzol for pReventIon of Recurrent sTroke in Africa
Lead Sponsor:
Northern California Institute of Research and Education
Conditions:
Stroke
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief Summary
Global estimates suggest that sub-Saharan Africa (SSA) now has the highest incidence, prevalence, and worst survival outcomes of stroke. With an estimated 1.4 million stroke survivors, outcomes of str...
Eligibility Criteria
Inclusion
- Above the age of 30 years; male or female (sex is a biological variable of interest)
- 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)
- Aspirin or clopidogrel monotherapy
- 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
- Legally competent to sign informed consent or have a LARs who is able to provide consent for them
- 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.
- Able to do labs at all study intervals (7 visits total)
Exclusion
- Unable to provide a valid informed consent
- 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.)
- Hemorrhagic stroke survivor within the last 2 years
- Use of an anticoagulant medication or indication for use of an anticoagulant (e.g. atrial fibrillation)
- On dual antiplatelet therapy (patients are eligible after completion of a course of dual antiplatelet therapy)
- Modified Rankin Scale 5
- Thrombocytopenia (platelet count \<1000,000)
- Severe liver dysfunction (active hepatitis or hepatic insufficiency with Child-Pugh score B or C)
- Congestive heart failure, defined as NYHA Class III or above (marked limitation of physical activity)
- Nursing/pregnant mothers
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT06919835
Start Date
December 1 2025
End Date
December 31 2027
Last Update
October 3 2025
Active Locations (1)
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1
Kwame Nkrumah University of Science & Technology
Kumasi, Ghana