Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06530537
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Cilostazol vs Aspirin in Acute Non-cardioembolic Stroke With Cerebral mIcrobleeds
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None