Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke "ATLANTIS"


Phase 3 Results

Eligibility Criteria

Inclusion Criteria

Ischemic stroke causing measurable neurological deficit presenting within 5 hours of onset, aged 18-79.

Exclusion Criteria

ICH as determined by CT scan, signs of cerebral ischemia in more than one third of the territory of the middle cerebral artery, only minor stroke symptoms or major symptoms that are rapidly improving, history of stroke within previous 6 months, coma, severe obtundation, fixed eye deviation, or complete hemiplegia, previous intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, arteriovenous malformation, or aneurysm, clinical presentation suggestive of subarachnoid hemorrhage, hypertension, presumed septic embolus, presumed pericarditis or presence of ventricular thrombus or aneurysm related to recent acute myocardial infarction, recent surgery or biopsy of a parenchymal organ, recent trauma with internal injuries or ulcerative wounds, recent head trauma, active or recent hemorrhage, known hereditary or acquired hemorrhagic diathesis, unsupported coagulation factor deficiency or oral anticoagulant therapy with prothrombin time greater than normal, pregnancy, lactation or parturition within previous 30 days, abnormal blood lab values, serious, advanced or terminal illness, current participation in another investigational drug trial.