A Dose-Response Controlled Trial of Bevifibatide for Acute Ischemic Stroke

Exclusion Criteria

• •CT or MR evidence of intracranial haemorrhage.
• •Pre-morbid disability with a mRS score ≥ 2.
• •Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%.
• •Planned treatment with dual antiplatelet therapy within 1week of the index stroke.
• •Any history of a primary or other intracerebral (parenchymal) haemorrhage (intraventricular, subarachnoid, subdural, epidural).
• •Any untreated or incompletely treated intracranial aneurysm, any intracranial vascular malformation or any intracranial tumour.
• •Currently pregnant or lactating, and those planned to conceive.
• •Subjects with positive urine HCG test results.
• •Known allergy to study medication or concomitant medications.
• •Gastrointestinal bleeding, urinary tract bleeding, or other major systemic haemorrhage within 30 days.
• •Any major surgery within 6 weeks of the index stroke.
• •History of heparin-induced thrombocytopenia.
• •Expected lifespan less than 3 months.
• •Pre-existing neurological or psychiatric disease that would confound the neurological functional outcome evaluations.
• •Any of the following laboratory tests: INR \[International Normalized Ratio\]\>2.0, PT\>1.3 times normal value, platelet count\<100 × 109/L, Hb\<10g/dl.
• •Systolic pressure greater than 180 mmHg or diastolic pressure greater than 110 mmHg after aggressive treatment.
• •Severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 μmol/L \[2.5 mg/dl\]).
• •History of liver dysfunction (AST/ALT exceeding the upper limit of normal by more than twice) or cirrhosis.
• •Arterial tortuosity and/or other arterial diseases that prevent the expected internal thrombectomy device from reaching the target vessel.
• •Unlikely to be available for 90-day follow-up.
• •Current participation in another treatment clinical trial.
• •Other conditions that are not suitable for participation in the study.