Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06530537

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cerebral Microbleeds Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

Location status: Recruiting

Location contact

Sheng Zhang

CONTACT

[email protected]

+8618758188313

Sheng Zhang

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cilostazol

Drug

Cilostazol 100mg twice daily

Aspirin

Drug

Aspirin 100mg once daily

Primary outcomes

  1. 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

    Head CT,Brain MRI,Cognitive Evaluation

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2031
Study completion
2031
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.