Safety of Intravenous Thrombolysis for Wake-up Stroke (Wake-Up Stroke)

The purpose is to demonstrate the safety of IV t-PA in ischemic stroke patients who present to the ED after awakening with the symptoms of suspected ischemic stroke.

This is an open label, multi-center, safety study of acute treatment with IV alteplase in ischemic stroke patients who wake-up with their symptoms. The primary outcome of this study is the frequency of symptomatic hemorrhagic transformation evident within 24 hours of treatment with IV t-PA. Clinical improvement defined as a decrease in the NIHSS score at 24 hours, 3 days and 90 days and modified Rankin at 3 days and 90 days. For patients that have CTA and CTP, the incidence of large vessel occlusion will be quantified.

Inclusion Criteria:

• Suspected acute ischemic stroke that occurred during sleep or patients who wake up with focal neurological symptoms. This includes all patients who were last known to be neurologically normal the night before,but then found upon awakening with stroke deficits. It will be considered that the last known onset time is the time when the patient was last known to be well.
• 18 to 80 years old
• NIHSS ≤25
• BP ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment. Treatment of higher systolic BP is permitted, prior to enrollment

• t-PA must be given within 3 hrs of awakening from sleep

  • Female patients of child-bearing potential must have a negative pregnancy test prior to enrollment

Exclusion Criteria:

• CT Exclusion Criteria: Hypodensity >1/3 MCA territory on non-contrast cranial CT scan or evidence of intracranial or subarachnoid hemorrhage
• Prior ischemic stroke within 3 months of the presenting event
• History of intracranial hemorrhage
• Known secured or unsecured cerebral aneurysm or vascular malformation
• Inability to control systolic BP > 185 mmHg or diastolic BP > 110 mmHg with IV anti-hypertensive medications
• Known coagulopathy or evidence of active bleeding
• Surgical procedures, biopsy, subclavian venous or arterial puncture, trauma within 14 days of the event
• Gastrointestinal or genitourinary bleeding within 14 days of the event
• Treated with IV heparin within the previous 24 hours & an abnormal PTT
• Oral anticoagulants & an INR >1.7
• Platelet count <100,000
• Venous glucose either <50 or >450
• Any patient who qualifies for this protocol should not be treated with IAT. If the treating physician believes a patient should undergo IAT, those patients should be identified a priori and not enrolled into this protocol