Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319846
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-03-13
Brief Title:
Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular EventsCHANCE-4
Sponsor:
Beijing Tiantan Hospital
Organization:
Beijing Tiantan Hospital
Study Overview
Official Title:
A Multicenter Double-blind Double-dummy Randomized Clinical Trial Comparing the Efficacy and Safety of Tirofiban Versus Placebo in Preventing Recurrence of Stroke for Patients With Intracranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular EventsCHANCE-4
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter double-blind double-dummy randomized clinical trial comparing the efficacy and safety of tirofiban versus placebo in preventing recurrence of stroke for patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events
Detailed Description:
This is a multicenter double-blind double-dummy randomized clinical trial to assess the effects of tirofiban versus placebo in preventing recurrence of stroke at 3-month in patients with intracranial artery stenosis and high-risk acute non-disabling cerebrovascular events The participants will receive study medication of tirofiban or placebo within 24 hours of symptom onset by a randomization ratio of 11 For tirofiban group - Initial infusion of tirofiban 04μgkg body weightminute for 30 minutes a maximum dose of 1mg within 24 hours of symptom onset followed by a continuous infusion of tirofiban 01μgkg body weightminute for 48 hours For placebo group - Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset followed by a continuous infusion of placebo for 48 hours The primary efficacy outcome is any new ischemic stroke at 3-month The primary safety outcome is type 3 or 5 bleeding events according to the BARC criteria at 3-month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None