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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Healthy Volunteers: f
View:

• Acute ischemic stroke (within 1 month of onset)

• Non-cardioembolic stroke

• Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI)

Locations
Other Locations
China
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Time Frame
Start Date: 2024-07-18
Estimated Completion Date: 2031-08-30
Participants
Target number of participants: 848
Treatments
Experimental: Cilostazol Group
Cilostazol 100mg twice daily
Active_comparator: Aspirin Group
Aspirin 100mg once daily
Related Therapeutic Areas
Sponsors
Leads: Zhejiang Provincial People's Hospital

This content was sourced from clinicaltrials.gov