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

Exclusion Criteria32

• Malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI.
• 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.
• Iatrogenic causes (angioplasty or surgery) of minor stroke or TIA.
• A score of > 2 on the modified Rankin scale before the symptom onset.
• 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)
• Tirofiban has been used since this onset.
• Hematocrit (HCT) <30%.
• 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).
• Planned or likely revascularization (any angioplasty or endovascular surgery) within the next 3 months.
• Scheduled for surgery or interventional treatment requiring study drug cessation.
• Severe non-cardiovascular comorbidity with life expectancy < 3 months.
• Inability to understand and/or follow research procedures due to mental, cognitive, or emotional disorders.
• 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.
• Participants who have large areas (greater than half of middle cerebral artery territory) of obvious low density on the baseline CT scan.
• Gastrointestinal bleed within 3 months or major surgery within 30 days.
• Diagnosis or suspicious diagnosis of acute coronary syndrome.
• Participation in another clinical study with an experimental product during the last 30 days.
• Currently receiving an experimental drug or device.
• Pregnant, currently trying to become pregnant, or of child-bearing potential and not using birth control.