Comparing cilostazol and aspirin for preventing stroke in patients with cerebral microbleeds
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
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 |
| Enrollment | 848 (estimated) |
| Ages | 35 Years and up |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06530537 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals who have had an acute non-cardioembolic ischemic stroke within the past month and have confirmed cerebral microbleeds.
Not a fit: Patients with a history of cerebral amyloid angiopathy or those requiring combined anticoagulant therapy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.