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

NCT06530537 | Recruiting Phase 3

• 1 other identifier: KY2024083
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Microbleeds; Stroke

Outcome Measures

Primary Outcomes (1)

• The rate of recurrent stroke

  Head CT,Brain MRI,Cognitive Evaluation

  Time Frame: baseline ,3-month,6-month, and every 1 year, follow-up time up to 4 years

Study Arms (2)

Cilostazol Group

EXPERIMENTAL

Cilostazol 100mg twice daily

Drug: Cilostazol

Aspirin Group

ACTIVE COMPARATOR

Aspirin 100mg once daily

Drug: Aspirin

Interventions

Cilostazol DRUG

Cilostazol 100mg twice daily

Cilostazol Group

Aspirin DRUG

Aspirin 100mg once daily

Aspirin Group

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Cilostazol; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 31, 2024
• Study Start: July 18, 2024
• Primary Completion (Estimated): August 30, 2031
• Study Completion (Estimated): August 30, 2031
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)