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Clinical Trials in China / NCT06530537
Recruiting Phase 3

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

NCT06530537 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang Provincial People's Hospital
Phase
Phase 3
Started
2024-07-18
Last updated
2024-07-31

Condition(s) studied

Cerebral MicrobleedsStroke

Investigational drug(s) / intervention(s)

CilostazolAspirin

Cilostazol: Cilostazol 100mg twice daily

Aspirin: Aspirin 100mg once daily

Study 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

Sex
ALL
Min age
35 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Acute ischemic stroke (within 1 month of onset) * Non-cardioembolic stroke * Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI) Exclusion Criteria: * 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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Recruiting

More Zhejiang Provincial People's Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06530537 on ClinicalTrials.gov ↗ ← All trials in China