Cilostazol vs. Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cilostazol, Aspirin.
- Who it may be relevant to
- Registry conditions: Cerebral Microbleeds, Stroke. Basic parameters: from 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
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.
Interventions
- Drug Cilostazol
Cilostazol 100mg twice daily - Drug Aspirin
Aspirin 100mg once daily
Primary outcome measures
- The rate of recurrent stroke [Time frame: Time Frame: baseline ,3-month,6-month, and every 1 year, follow-up time up to 4 years]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhejiang Provincial People's Hospital — Hangzhou
Identifiers
NCT: NCT06530537 · KY2024083