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

Ki vehet részt

• 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

Ki nem vehet részt

• 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