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）
Overview
- Phase
- Phase 3
- Intervention
- Tirofiban
- Conditions
- Ischemic Stroke, Acute
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 4674
- Locations
- 5
- Primary Endpoint
- Any new ischemic stroke at 3-month
- Status
- Recruiting
- Last Updated
- last year
Overview
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 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.
Investigators
Yongjun Wang
President of Beijing Tiantan Hospital
Beijing Tiantan Hospital
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Tirofiban
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Any new ischemic stroke at 3-month
Time Frame: at 3-month
Incidence of any new ischemic stroke at 3-month
Type 3 or 5 bleeding events according to the BARC criteria at 3-month
Time Frame: at 3-month
Incidence of type 3 or 5 bleeding events according to the BARC criteria at 3-month
Secondary Outcomes
- New clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ myocardial infarction/vascular death) within 3 months and 1 year; Each new vascular event will be independently evaluated.(Within 3 months after randomization and 1 year)
- Any new ischemic stroke within 1 year(within 1 year)
- Incidence and severity of recurrent stroke and TIA(Within 3 months after randomization and 1 year)
- Neurological impairment at 3 months (NIHSS increased≥4 from baseline ).(at 3 months)
- Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year(at 3 months and 1 year)