Safety of Intravenous Thrombolysis for Wake-up Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Alteplase (iv t-PA)
Intervention description: 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
Intervention MeSH terms: Tissue Plasminogen Activator; Plasminogen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Wake-Up Stroke; Ischemic stroke; ischemic stroke patients who wake-up with their symptoms

Summary:

      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.
    

Eligibility criteria:

        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