Status:
NOT_YET_RECRUITING
Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol
Lead Sponsor:
First Affiliated Hospital of Chengdu Medical College
Conditions:
Cerebral Small Vessel Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This study is designed to evaluate whether cilostazol, an antiplatelet medication, is more effective and safer than aspirin or clopidogrel in preventing recurrent strokes and slowing disease progressi...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years.
- Diagnosis of small artery occlusion ischemic stroke based on the TOAST classification, with symptom onset within the past 6 months.
- MRI findings indicating white matter hyperintensities, with Fazekas grade ≥2.
- mRS (modified Rankin Scale) score ≤2.
- CDR (Clinical Dementia Rating) score \<1.
Exclusion
- Presence of other central nervous system (CNS) disorders, including CNS infections, immune-mediated or degenerative diseases, epilepsy, intracranial tumors, etc.
- History of drug or alcohol abuse, or severe psychiatric disorders.
- Diagnosis of malignant tumors.
- Severe hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 times the upper limit of normal) or renal impairment (creatinine clearance \<25 mL/min).
- Concomitant congestive heart failure.
- Systemic hemorrhagic disorders or bleeding tendency, including platelet count ≤100,000/mm³, coagulation abnormalities, gastrointestinal ulcers, or history of non-traumatic symptomatic intracranial hemorrhage.
- Conditions requiring long-term anticoagulation therapy, such as atrial fibrillation or deep vein thrombosis.
- Known allergy or contraindication to cilostazol, clopidogrel, or aspirin.
- Requirement for dual antiplatelet therapy during the study period (e.g., due to vascular stent implantation or symptomatic intracranial arterial stenosis).
- Inability to complete scale assessments or comply with long-term follow-up.
- Pregnancy, lactation, or planning to become pregnant.
- Participation in another interventional clinical trial.
- Any other condition deemed unsuitable for study participation by the investigator.
Key Trial Info
Start Date :
September 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
632 Patients enrolled
Trial Details
Trial ID
NCT07180472
Start Date
September 20 2025
End Date
December 1 2027
Last Update
September 23 2025
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