NCT06530537

Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 848 (estimated)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Microbleeds
• Stroke

Interventions

Type	Name	Description
DRUG	Cilostazol	Cilostazol 100mg twice daily
DRUG	Aspirin	Aspirin 100mg once daily

Timeline

• Start date: 2024-07-18
• Primary completion: 2031-08-30
• Completion: 2031-08-30
• First posted: 2024-07-31
• Last updated: 2024-07-31

Locations

1 site across 1 country: China