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)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 40 years or older than 40 years;

• Acute cerebral ischemic event due to:

‣ Acute non-disabling ischemic stroke (NIHSS≤5 at the time of randomization) or,

⁃ TIA with moderate-to-high risk of stroke (ABCD2 score ≥ 6 at the time of randomization);

• Accompanied with symptomatic intracranial artery stenosis, defined as ≥ 50% stenosis of the infarcted ipsilateral intracranial artery. Intracranial arteries include intracranial segments of internal carotid arteries, intracranial segments of vertebral arteries, M1-M2 segments of middle cerebral arteries, A1-A2 segments of anterior cerebral arteries, P1-P2 segments of posterior cerebral arteries, and basilar artery. The techniques for detecting intracranial artery stenosis are limited to: MRA, CTA, or DSA. The measurement for the degree of stenosis has been established by the WASID (Warfarin-Aspirin Symptomatic Intracranial Disease) study. (AJNR Am J Neuroradiol. 2000;21:643-646.);

• Can be treated with study drug within 24 hours of symptoms onset\*(\*Symptom onset is defined by the last seen normal principle);

• Informed consent signed.

Locations
Other Locations
China
People's Hospital of Qihe County
RECRUITING
Dezhou
The 2nd Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Liaocheng People's Hospital(Liaocheng Brain Hospital)
RECRUITING
Liaocheng
Third People's Hospital of Liaocheng
RECRUITING
Liaocheng
Yantai Penglai traditional Chinese medicine hospital
RECRUITING
Yantai
Contact Information
Primary
Yongjun Wang
yongjunwang@ncrcnd.org.cn
13911172565
Backup
Jing Jing
jingj_bjttyy@163.com
15810312511
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2026-12
Participants
Target number of participants: 4674
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov

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