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

Korábbi kezelés

• 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.

Más betegség

• 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.

Laborértékek

• 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)

Egyéb

• 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.

• 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.