Safety Study of a Recombinant Human Plasminogen Activator to Treat Acute Ischemic Stroke.

Inclusion Criteria: * Subjects with cerebral ischemia at any location producing a serious measurable deficit by NIHSS scale and who received study medication within 5 hours after the onset of the symptom. A serious measurable deficit by NIHSS was defined as the NIHSS  9 and  20 (for brain stem stroke, patients with NIHSS \> 20 were included). * Subjects were  18 years old, of either sex. * Subjects or his/her legal guardians demonstrated their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Subjects with Modified Rankin Scale \> 1. Exclusion Criteria: * Onset of symptoms on awaking from sleep. * Intracranial bleeding detected on a pretreatment head computerized tomographic (CT) scan. * Clinical presentation suggested a subarachnoid hemorrhage even if the head CT scan was normal. * Head CT showed the evidence of early infarct sign \> 1/3 of MCA territory. * Subjects had generalized seizure at the onset of the stroke. * Subjects with blood glucose \< 50 mg/dl or \> 400 mg/dl. * Subjects had another stroke, head trauma, cerebral hemorrhage or ischemic infarction within 3 months prior to the study entry. * Subjects with a significant surgery within 14 days prior to study entry. * Subjects with a history of gastrointestinal or urinary tract hemorrhage within 21 days prior to the study entry. * Subjects with lumbar puncture or arterial puncture of non-compressible site within 14 days prior to the study entry. * Subjects had known bleeding diathesis. * Subjects with other serious medical illness that interfered with the study. * Subjects had a platelet count \< 100,000/mm3; hematocrit \< 30%. * Subjects with other serious medical illness that interfered with the study. * Subjects had aPTT or PT \> upper normal limit. * Subjects had uncontrolled hypertension (\> 180 mmHg systolic or \> 110 mmHg diastolic) without additional anti-hypertensive medication at screening visit. * Subjects with recent transmural myocardial infarction and evidence of pericarditis within 3 weeks prior to the enrollment. * Subjects had intracranial neoplasm, arteriovenous malformation, or aneurysm. * Subjects had hemostasis defects including secondary to severe hepatic or renal disease. * Subjects with history of drug or alcohol abuse within 1 year prior to the study entry. * Subjects had significant hepatic dysfunction (SGOT/SGPT  3 x upper normal limit). * Subjects had serum creatinine level  2 x upper normal limit or on renal dialysis. * Subjects had administration of any other investigational drug within 30 days prior to study entry. * Woman who was pregnant or nursing. * Subjects had used other thrombolytics (streptokinase, tissue plasminogen activator, urokinase, anisoylated plasminogen streptokinase activator complex, anticoagulants). * Subjects had severe cardiac disease (New York Heart Association Functional Classification III and IV). * Subjects had history of cancer except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or any cancer in patient's disease free for more than 5 years. * Subjects had any clinically significant deviation from normal in the physical examination that, in the investigator judgment, interfered with the study evaluation or affect subject safety. * Subjects with history of lupus. * Vasculitis was the cause of ischemic stroke. * Subjects had been enrolled in this study previously.