Safety of Intravenous Thrombolytics in Stroke on Awakening
Condition: Stroke
MeSH terms: Stroke
Intervention: tPA
Intervention description: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.
Intervention MeSH terms: Tissue Plasminogen Activator
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Stroke; Wake up; IV tPA; Thrombolytic

Summary:

      The primary objective of this study is to evaluate the safety of intravenous tissue
      plasminogen activator (IV tPA) in patients waking up with symptoms of acute stroke and
      presenting to the Emergency Department (ED) within 4.5 hours from awakening, and meeting
      standard criteria for treatment with IV tPA for acute stroke.

      The hypothesis is that patients that wake up with stroke symptoms may have developed the
      stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the
      ED within that time, therefore IV tPA should be safe and effective in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater or equal to 18 years, and lower or equal to 80 years.

          -  Signs and symptoms of acute ischemic stroke.

          -  Symptoms present upon awakening.

          -  Arriving to the Emergency Department within 4.5 hours of awakening. Treatment with IV
             tPA must be initiated prior to 4.5hours from waking up.

          -  NIHSS >3

          -  A non-contrast head CT without hemorrhage and without hypodensity more than 1/3 of the
             middle cerebral artery (MCA) territory; or MRI demonstrating no hemorrhage, and with a
             diffusion-weighted imaging (DWI) lesion no greater than 70 mL and FLAIR without a well
             defined hyperintense lesion that is more than 1/3 of the MCA territory.

          -  Pre-morbid modified Rankin score of 0 or 1.

        Exclusion Criteria:

          -  Rapidly improving deficit to an NIHSS less than 3.

          -  Sustained systolic blood pressure greater than 185 mmHg or diastolic blood pressure
             greater than 110 mmHg despite treatment.

          -  Glucose less than 50 mg/dL.

          -  Stroke or head trauma within last 3 months.

          -  History of intracranial hemorrhage. Symptoms of subarachnoid hemorrhage.

          -  Major surgery within 14 days.

          -  Gastrointestinal (GI)/Genito-urinary (GU) hemorrhage within 21 days.

          -  International normalized ratio (INR) > 1.7.

          -  Heparin within 48 hours with an elevated activated partial thromboplastin time (aPTT).

          -  Platelet count less than 100,000.

          -  Presumed septic embolus or suspicion of bacterial endocarditis.

          -  Suspicion of aortic dissection.

          -  Use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin.

          -  Pregnant or lactating women.

          -  Known allergy or sensitivity to tPA.