RecruitingPhase 3NCT06530537

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


Sponsor

Zhejiang Provincial People's Hospital

Enrollment

848 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 35 Years

Inclusion Criteria3

  • Acute ischemic stroke (within 1 month of onset)
  • Non-cardioembolic stroke
  • Presence of cerebral microbleeds (CMBs) confirmed by susceptibility-weighted imaging (SWI)

Exclusion Criteria5

  • 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)

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Interventions

DRUGCilostazol

Cilostazol 100mg twice daily

DRUGAspirin

Aspirin 100mg once daily


Locations(1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

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NCT06530537


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