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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(CHANCE-4)
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.
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 1:1. For tirofiban group - Initial infusion of tirofiban 0.4μg/kg body weight/minute for 30 minutes (a maximum dose of 1mg) within 24 hours of symptom onset, followed by a continuous infusion of tirofiban 0.1μg/kg body weight/minute 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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
People's Hospital of Qihe County
Dezhou, Shandong, China
Liaocheng People's Hospital(Liaocheng Brain Hospital)
Liaocheng, Shandong, China
Third People's Hospital of Liaocheng
Liaocheng, Shandong, China
Yantai Penglai traditional Chinese medicine hospital
Yantai, Shandong, China
Start Date
July 11, 2024
Primary Completion Date
October 1, 2025
Completion Date
December 1, 2026
Last Updated
July 12, 2024
4,674
ESTIMATED participants
Tirofiban
DRUG
Placebo
DRUG
Lead Sponsor
Beijing Tiantan Hospital
NCT07484243
NCT05691465
Data Source & Attribution
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