Tests tirofiban against placebo to prevent repeat stroke
Tests tirofiban, or a placebo, in adults with narrowed brain arteries and mini-strokes.
Key facts
- Who runs it
- Beijing Tiantan Hospital
- Where
- Dezhou, Harbin, Liaocheng, and Yantai, ChinaSee the 5 sites
- Trial code
- Registry title
- Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4)
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 4,674 people, planned
- Started
- 11 Jul 2024
- Expected to end
- Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Tirofiban
- Placebo
- Record updated
- 12 July 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older who had a mild stroke or a high-risk mini-stroke (TIA) within the last 24 hours, with a narrowed artery inside the head. It compares tirofiban with placebo to see which better prevents another stroke.
- Age
- 40 years or older
- Sex
- Men and women can join.
- Disease stage
- Mild ischemic stroke (NIHSS 5 or less) or TIA with a high stroke risk (ABCD2 score 6 or more), together with at least 50% narrowing of the related artery inside the head, shown by MRA, CTA or DSA.
- Earlier treatment
- Study drug must be started within 24 hours of symptom onset. People who already took tirofiban since this event, took heparin or blood thinners by mouth within 10 days, or had clot-dissolving treatment or thrombectomy within 24 hours cannot join.
Main reasons for not taking part
- Another cause of symptoms on brain scan, such as tumor, abscess or multiple sclerosis
- Atrial fibrillation, artificial heart valve or other clear need for blood thinners
- Past brain bleeding, aneurysm, asthma or COPD
- Bleeding disorder, severe kidney, liver or heart failure, or low platelet or white blood cell count
- Pregnant, trying to become pregnant, or able to have children without birth control
The registry criteria, word for word
Show all 30 criteriaShow less
Who can take part
- 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
Who cannot take part
- Planned or likely revascularization (any angioplasty or endovascular surgery) within the next 3 months
- Scheduled for surgery or interventional treatment requiring study drug cessation
- Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
- Intravenous thrombolytic therapy (such as intravenous rtPA) or mechanical thrombectomy within 24 hours prior to randomization
- Gastrointestinal bleed within 3 months or major surgery within 30 days
- Currently receiving an experimental drug or device
- Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI
- Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA
- Clear indication for anticoagulation (presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
- History of intracranial hemorrhage or amyloid angiopathy
- History of aneurysm (including intracranial aneurysm and peripheral aneurysm)
- History of asthma or COPD (chronic obstructive pulmonary disease)
- High-risk for bradyarrhythmia (sinus node disease, first-degree or second-degree AV block, and brady-arrhythmic syncope without pacemaker)
- Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders
- Diagnosis or suspicious diagnosis of acute coronary syndrome
- Contraindication for tirofiban:; Known allergy; Severe renal (creatinine exceeding 1.5 times of the upper limit of normal range) or hepatic (ALT or AST > twice the upper limit of normal range) insufficiency; Severe cardiac failure (NYHA level: III to IV); History of hemostatic disorder or systemic bleeding; History of thrombocytopenia or neutropenia; History of drug-induced hematologic disorder or hepatic dysfunction; Low white blood cell (<2×109/L) or platelet count (<100×109/L)
- Unable to complete the evaluation of intracranial artery stenosis before randomization
- Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
- A score of > 2 on the modified Rankin scale before the symptom onset
- Tirofiban has been used since this onset
- Hematocrit (HCT) <30%
- Severe non-cardiovascular comorbidity with life expectancy < 3 months
- Participants who have large areas (greater than half of middle cerebral artery territory) of obvious low density on the baseline CT scan
- Participation in another clinical study with an experimental product during the last 30 days
- Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control
Where in China
- People's Hospital of Qihe CountyDezhou, ChinaContact: Haitao LiTaking people
- The 2nd Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Lihua WangTaking people
- Liaocheng People's Hospital(Liaocheng Brain Hospital)Liaocheng, ChinaContact: Xiafeng YangTaking people
- Third People's Hospital of LiaochengLiaocheng, ChinaContact: Liguo ChangTaking people
- Yantai Penglai traditional Chinese medicine hospitalYantai, ChinaContact: Penglai ShiTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Tirofiban groupTreatment being tested
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.
Treatment: Tirofiban
- Placebo groupPlacebo, for comparison
Initial infusion of saline placebo for 30 minutes within 24 hours of symptom onset, followed by a continuous infusion of placebo for 48 hours.
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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 Events(CHANCE-4)
- Plain-language title
- Tests tirofiban against placebo to prevent repeat strokeGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 12 July 2024