Tests tirofiban against placebo to prevent repeat stroke
Tests tirofiban, or a placebo, in adults with narrowed brain arteries and mini-strokes.
Plain-language title generated from the registry record
Registry title: Tirofiban for Patients With intraCranial Artery Stenosis and High-risk Acute Non-disabling Cerebrovascular Events(CHANCE-4）
Key facts
- Where
- Dezhou, Harbin, Liaocheng, and Yantai, ChinaSee the 5 sites
- Phase
- Phase 3
Where in China
- People's Hospital of Qihe CountyDezhou, ChinaTaking people
- The 2nd Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaTaking people
- Liaocheng People's Hospital（Liaocheng Brain Hospital）Liaocheng, ChinaTaking people
- Third People's Hospital of LiaochengLiaocheng, ChinaTaking people
- Yantai Penglai traditional Chinese medicine hospitalYantai, ChinaTaking people
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?
Trial details
- Who runs it
- Beijing Tiantan Hospital
- Trial code
- NCT06319846
- Record updated
- 12 July 2024
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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.