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

NCT ID: NCT06530537

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

848 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2031-08-30

Brief Summary

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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

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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

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Cerebral Microbleeds Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cilostazol Group

Cilostazol 100mg twice daily

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

Cilostazol 100mg twice daily

Aspirin Group

Aspirin 100mg once daily

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

Aspirin 100mg once daily

Interventions

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Cilostazol

Cilostazol 100mg twice daily

Intervention Type DRUG

Aspirin

Aspirin 100mg once daily

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Sheng Zhang

Role: primary

Other Identifiers

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KY2024083

Identifier Type: -

Identifier Source: org_study_id