Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
NCT06530537 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 848
Last updated 2024-07-31
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.
Conditions
- Cerebral Microbleeds
- Stroke
Interventions
- DRUG
-
Cilostazol
Cilostazol 100mg twice daily
- DRUG
-
Aspirin 100mg once daily
Sponsors & Collaborators
-
Zhejiang Provincial People's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-18
- Primary Completion
- 2031-08-30
- Completion
- 2031-08-30
Countries
- China
Study Locations
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