Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
The purpose of this clinical trial is to demonstrate that cilostazol is non-inferior to aspirin in terms of efficacy and safety for the secondary prevention of stroke in patients with acute non-cardioembolic ischemic stroke who have concurrent microbleeds. Researchers will compare the medication cilostazol with aspirin
| Condition(s) | Cerebral Microbleeds, Stroke |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of this clinical trial is to demonstrate that cilostazol is non-inferior to aspirin in terms of efficacy and safety for the secondary prevention of stroke in patients with acute non-cardioembolic ischemic stroke who have concurrent microbleeds. Researchers will compare the medication cilostazol with aspirin to assess its efficacy and safety in these patients. Participants will: Take the medication cilostazol or aspirin daily as part of an antiplatelet drug therapy. Have baseline data and follow-up data collected at the time of hospital admission, and then at 3 months, 6 months post-discharge, and annually thereafter up to 4 years. Have the primary endpoint set as stroke recurrence, with secondary endpoints being composite vascular events. Safety events will include moderate to |
| Who can participate | 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) |
| Ages | 35 Years |
| Sex | All |
| Lead sponsor | Zhejiang Provincial People's Hospital |
| Locations | Hangzhou, Zhejiang, China |
| Start date | 2024-07-18 |
| NCT ID | NCT06530537 |
| Official listing | https://clinicaltrials.gov/study/NCT06530537 |