Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
- Registration Number
- NCT06530537
- Lead Sponsor
- Zhejiang Provincial People's Hospital
- Brief 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 severe hemorrhage and bleeding at any site.
- Detailed Description
The plan is to enroll patients with acute non-cardioembolic stroke who have concurrent cerebral microbleeds (CMBs). After enrollment, patients will be randomly assigned to either the Cilostazol group (experimental group, Cilostazol 100mg, twice daily) or the Aspirin group (control group, Aspirin 100mg, once daily). The treatment goals for blood pressure, blood sugar, and blood lipids will be strictly controlled according to the relevant guidelines. Baseline and follow-up data will be collected at the time of enrollment, and at 3 months, 6 months, and annually (up to 4 years) after enrollment.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 848
- Acute ischemic stroke (within 1 month of onset)
- Non-cardioembolic stroke
- Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cilostazol Group Cilostazol Cilostazol 100mg twice daily Aspirin Group Aspirin Aspirin 100mg once daily
- Primary Outcome Measures
Name Time Method The rate of recurrent stroke Time Frame: baseline ,3-month,6-month, and every 1 year, follow-up time up to 4 years Head CT,Brain MRI,Cognitive Evaluation
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China