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RECRUITING
NCT06530537
PHASE3

Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

848

Start Date

2024-07-18

Completion Date

2031-08-30

Last Updated

2024-07-31

Healthy Volunteers

No

Interventions

DRUG

Cilostazol

Cilostazol 100mg twice daily

DRUG

Aspirin

Aspirin 100mg once daily

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China