Safety of Intravenous Thrombolysis for Wake-up Stroke
Safety of Intravenous Thrombolysis for Wake-up Stroke
The purpose is to demonstrate the safety of intravenous tissue plasminogen activator (IV
 t-PA) in ischemic stroke patients who present to the emergency department (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 National Institutes
 of Health Stroke Scale (NIHSS) score at 24 hours, 3 days and 90 days and modified Rankin
 Scale (mRS) score at 3 and 90 days. For patients that have computed tomographic angiogram
 (CTA) and computed tomographic perfusion (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 (National Institutes of Health Stroke Scale) ≤25

 -  Blood Pressure ≤185 mmHg systolic & ≤110 mmHg diastolic at the time of enrollment.

 Treatment of higher systolic BP is permitted, prior to enrollment

 -  IV t-PA must be given within 3 hours 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 middle cerebral artery (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 (partial
 thromboplastin time) PTT

 -  Oral anticoagulants & an (international normalized ratio) 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 (intra-arterial
 therapy) IAT If the treating physician believes a patient should undergo IAT, those
 patients should be identified a priori and not enrolled into this protocol