Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）

Phase 3

Recruiting

• Conditions: Symptomatic Intracranial Artery Stenosis; Ischemic Stroke, Acute; TIA
• Interventions: Drug: Placebo; Drug: Tirofiban

• Registration Number: NCT06319846
• Lead Sponsor: Beijing Tiantan Hospital

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.

Study Timeline

• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Study First Posted: 2024-03-20
• Status Verified: 2024-07
• Study Start: 2024-07-11
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4674

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
Tirofiban group	Tirofiban	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.

Primary Outcome Measures

Name	Time	Method
Any new ischemic stroke at 3-month	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	at 3-month	Incidence of type 3 or 5 bleeding events according to the BARC criteria at 3-month

Secondary Outcome Measures

Name	Time	Method
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	Incidence of 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.
Any new ischemic stroke within 1 year	within 1 year	Incidence of any new ischemic stroke within 1 year
Incidence and severity of recurrent stroke and TIA	Within 3 months after randomization and 1 year	Incidence and severity of recurrent stroke and TIA during follow-up to 3 months and 1-year (Severity is measured using a six-level ordered categorical scale that incorporates the mRS: fatal stroke/severe non-fatal stroke \[mRS 4 or 5\]/moderate stroke \[mRS 2 or 3\]/mild stroke \[mRS 0 or 1\]/TIA/no stroke-TIA)
Neurological impairment at 3 months (NIHSS increased≥4 from baseline ).	at 3 months	Proportion of patients with neurological impairment at 3 months ( National Institutes of Health Stroke Scale \[NIHSS\] score increased≥4 from baseline).
Disabling stroke (Modified Rankin Scale score, mRS>1) at 3 months and 1 year	at 3 months and 1 year	Proportion of patients with disabling stroke (Modified Rankin Scale score, mRS\>1) at 3 months and 1 year. Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death).

Trial Locations

Locations (5)

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

Yantai Penglai traditional Chinese medicine hospital; 🇨🇳 Yantai, Shandong, China

Third People's Hospital of Liaocheng; 🇨🇳 Liaocheng, Shandong, China