Activated Protein C in Acute Stroke Trial
Condition: Stroke
MeSH terms: Stroke
Intervention: Activated Protein C
Intervention description: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset
Intervention MeSH terms: Drotrecogin alfa activated; Protein C
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Ischemic Stroke

Summary:

      The purpose of this research study is to determine the safety and learn more about the dose
      of Activated Protein C (APC) in reducing the damage from stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptoms of acute ischemic stroke; acute ischemic stroke is defined as the sudden
             onset of a measurable neurological deficit presumably attributable to focal cerebral
             ischemia, and otherwise not attributable to ICH or other disease process

          -  Symptom onset within 0-9 hours of administration of study medication Stroke onset is
             defined as the time of first symptoms or signs of neurologic deficit. If the onset of
             symptoms/signs is unwitnessed, time of onset is presumed to be the last time the
             patient was observed to be intact

          -  Neurologic deficit on examination with NIHSS of greater than 4 and less than 23

          -  In women of childbearing potential, a negative urine pregnancy test prior to
             enrollment (to be confirmed later by serum test)

          -  Signed informed consent by subject or authorized representative

        Exclusion Criteria:

          -  Computed tomography scan of the brain with evidence of intracranial hemorrhage or any
             finding not consistent with acute ischemic stroke as cause of presenting symptoms

          -  CT imaging demonstrating hypodensity more than 1/3 of MCA territory or mass effect

          -  Neurological (other than presenting stroke) or psychiatric condition that may affect
             the patient's functional status or that may interfere with the patient's assessment

          -  Clinically relevant pre-existing neurological deficit (historical modified Rankin
             score greater than 2 regardless of cause)

          -  Treatment with tissue plasminogen activator or other thrombolytic agent within 3
             months, including treatment with tissue plasminogen activator for current stroke

          -  Need for treatment with anti-platelet agent or anticoagulant within 36 hours

          -  Previous stroke or serious head trauma within 3 months

          -  Major surgery within previous 14 days

          -  History of intracranial hemorrhage

          -  Rapidly improving or minor symptoms

          -  Symptoms suggestive of subarachnoid hemorrhage

          -  Gastrointestinal hemorrhage or urinary tract hemorrhage within previous 21 days

          -  Arterial puncture at noncompressible site within the previous 7 days

          -  Seizure at onset of stroke

          -  Use of oral anticoagulant medications at time of symptom onset or treatment with
             subcutaneous or intravenous heparin within previous 48 hours with elevated partial
             thromboplastin time

          -  INR values greater than 1.5

          -  Platelet count less than 100,000/μL

          -  Glucose concentration less than 40 mg/dL or greater than 400mg/dL

          -  Participation in another clinical trial within the last 30 days, or planned
             participation in another clinical trial

          -  Women who are currently breast-feeding

          -  Known resistance to activated Protein C (Factor V Leiden mutation)