Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06522113
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Cilostazol and Aspirin in Stroke and TIA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This study is a randomized open-labelled trial We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin The primary outcome was stroke ischemic or hemorrhagic during 90 days of follow-up in an intention-to-treat analysis
Detailed Description:
This study is a randomized open-labelled trial We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin aspirin 100mg with cilostazol 200 mg for 21 days or to clopidogrel plus aspirin aspirin 100mg with clopidogrel 75mg for 21 days The primary outcome was stroke ischemic or hemorrhagic during 90 days of follow-up in an intention-to-treat analysis The primary safety outcome was the moderate-to-severe bleeding event according to GUSTO definition The secondary outcomes were new clinical vascular event ischemic or hemorrhagic stroke myocardial infarction or vascular death analyzed as a composite outcome and also as individual outcomes Vascular death was defined as death due to stroke ischemic or hemorrhagic systemic hemorrhage myocardial infarction congestive heart failure pulmonary embolism sudden death or arrhythmia
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