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Taking people in ChinaPhase 3

Compares cilostazol and aspirin after non-cardioembolic stroke with brain microbleeds

Tests cilostazol against aspirin in adults with stroke and brain microbleeds.

Key facts

Who runs it
Zhejiang Provincial People's Hospital
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
Status
Recruiting
Phase
Phase 3
People taking part
848 people, planned
Started
18 Jul 2024
Expected to end
30 Aug 2031
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cilostazol
  • Aspirin
Record updated
31 July 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who recently had a stroke not caused by the heart and who also have tiny brain bleeds (microbleeds) seen on a scan. It compares cilostazol with aspirin.

Age
35 years or older
Sex
All sexes can join.
Disease stage
A recent stroke caused by a blocked blood vessel (within 1 month of onset), not caused by a problem in the heart. Tiny brain bleeds (cerebral microbleeds) must be seen on a special scan (SWI).
Earlier treatment
People who needed long-term dual antiplatelet therapy (more than 1 month) or combined anticoagulant therapy cannot join. People who had severe side effects to aspirin or cilostazol before cannot join.
Biomarker or test result
Cerebral microbleeds confirmed by susceptibility-weighted imaging (SWI).

Main reasons for not taking part

  • Known cerebral amyloid angiopathy (CAA) by the Boston 2.0 criteria
  • Past bleeding in the brain highly suspected to be caused by CAA
  • Past severe reaction to aspirin or cilostazol, such as active bleeding or severe allergy
  • Need for combined anticoagulant therapy
  • Need for long-term dual antiplatelet therapy (more than 1 month)

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

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

Who cannot take part

  • Previous diagnosis of cerebral amyloid angiopathy (CAA) according to the Boston 2.0 diagnostic criteria
  • Requirement for combined anticoagulant therapy
  • Requirement for long-term dual antiplatelet therapy (>1 month)
  • 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

Where in China

  • Zhejiang Provincial People's HospitalHangzhou, ChinaContact: Sheng ZhangTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Cilostazol GroupTreatment being tested

    Cilostazol 100mg twice daily

    Treatment: Cilostazol

  • Aspirin GroupExisting treatment, for comparison

    Aspirin 100mg once daily

    Treatment: Aspirin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Compares cilostazol and aspirin after non-cardioembolic stroke with brain microbleedsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
31 July 2024