Thrombolysis With rhPro-UK in 4.5-6 Hours After Acute Ischemic Stroke in a Double-blinded,Controlled Trial

Inclusion criteria

• Ischemic stroke with symptoms of neurological deficits.
• Aged 18 to 80 years,male or famale.
• NIH Stroke Scale（NIHSS）scores of 4 to 25.
• Treatment 4.5 to 6 hours after stroke onset.(Stroke onset time is defined as the last time a patient with no clinical neurological deficit,for patients who wake up with stroke symptoms, consider that stroke occurs when the patient begins to fall asleep).
• The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
• CT showed negative or signs of early infarction.
• Patients and/or their families are willing to participate in this study and agree to sign informed consent.

Exclusion criteria

• Patients with premorbid modified Rankin Scale(mRS) score ≥2
• CT showed multiple infarctions（low density> 1/3 cerebral hemisphere）.
• Transient ischemic attack.
• Epileptic seizure when stroke onset.
• Intracranial tumor, arteriovenous malformation and aneurysm.
• Iatrogenic Stroke.
• Thrombectomy is planned.
• Cardioembolism and atrial fibrillation.
• Myocardial infarction history within 3 months.
• Severe cerebral trauma or stroke history within 3 months.
• Blood pressure is still out of control after aggressive antihypertensive treatment.Uncontrolled blood pressure is defined as systolic blood pressure≥ 180mmHg or diastolic blood pressure≥100mmHg.
• High density lesions (bleeding) and subarachnoid hemorrhage is revealed by emergency CT examination.
• Active visceral hemorrhage.
• Patients with intracerebral hemorrhage history.
• Patients with diabetic retinopathy history.
• Puncture in 1 week which can not be oppressed.
• Major surgery or severe trauma within 2 weeks.
• Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
• Heparin treatment within 48 hours (APTT above normal upper limit).
• Taking anticoagulant drugs orally, and PT >15s or INR >1.7.
• High risk of acute hemorrhage include platelet count<10^9/L.
• Taking thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination(e.g. APTT, INR, PLT, FIB、TT or appropriate Ⅹ a factor activity test, etc.).
• Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
• Pregnancy, lactating or menstrual women.
• Patients who have difficulty swallowing and are unable to take medications orally.
• Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions.