Comparing cilostazol and aspirin for preventing stroke in patients with cerebral microbleeds
Official title: The Efficacy and Safety of Cilostazol Compared to Aspirin in Acute Non-Cardioembolic Stroke Patients With Concurrent Cerebral Microbleeds: An Open-Label, Endpoint-Blinded, Randomized Non-Inferiority Clinical Trial
Run by Zhejiang Provincial People's Hospital · NCT06530537 · Data updated 2026-11-12
This study is testing if a medication called cilostazol can prevent strokes as effectively as aspirin in patients who have had a stroke and also have small bleeding spots in the brain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 35 Years and up |
| Sex | All |
| Enrollment | 848 (estimated) |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 18, 2024 |
| Main results expected | August 30, 2031 |
| Study ends | August 30, 2031 |
| Registry record updated | July 31, 2024 |
| Trial ID | NCT06530537 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals who have had an acute non-cardioembolic ischemic stroke within the past month and have confirmed cerebral microbleeds.
✕Probably not a fit
Patients with a history of cerebral amyloid angiopathy or those requiring combined anticoagulant therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of cilostazol compared to aspirin for the secondary prevention of stroke in patients who have experienced an acute non-cardioembolic ischemic stroke and have concurrent cerebral microbleeds. Participants will be randomly assigned to receive either cilostazol or aspirin, with their health monitored through baseline and follow-up assessments at various intervals over four years. The primary focus will be on stroke recurrence, while secondary endpoints will include other vascular events and safety assessments related to bleeding. The study seeks to determine if cilostazol is non-inferior to aspirin in this specific patient population.
Why it matters
Potential benefit: If successful, this study could provide an alternative treatment option for patients at risk of stroke with cerebral microbleeds.
How similar studies have gone: While the specific comparison of cilostazol and aspirin in this context may be novel, similar studies have explored antiplatelet therapies in stroke prevention with varying degrees of success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute ischemic stroke (within 1 month of onset) * Non-cardioembolic stroke * Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI) Exclusion Criteria: * Previous diagnosis of cerebral amyloid angiopathy (CAA) according to the Boston 2.0 diagnostic criteria * History of intracerebral hemorrhage highly suspected to be caused by CAA-related lobar hemorrhage * Severe adverse reactions (such as active bleeding, severe allergies, etc.) to aspirin or cilostazol in the past, leading to non-compliance with medication * Requirement for combined anticoagulant therapy * Requirement for long-term dual antiplatelet therapy (\>1 month)
Where it's running
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Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.