Inclusion and Exclusion Criteria: RHAPSODY

Inclusion Criteria

  • Age 18 to 80 years, inclusive
  • Acute hemispheric ischemic stroke defined as focal, neurological deficit(s), secondary to a presumed vascular occlusive event
  • Able to receive IV tPA within 3 hours of stroke onset
  • National Institutes of Health Stroke Scale (NIHSS) score of 7 to 20
  • Signed informed consent by subject or authorized representative
  • Agreement to use effective birth control throughout the study (i.e., day 90):
    • Males-barrier method of contraception plus a spermicide
    • Females of childbearing potential (i.e., not surgically sterile or post-menopausal defined as age > 51 years without menses for ≥ 2 years) – hormonal contraception or barrier method of contraception plus a spermicide)
  • Willing (subject and/or caretaker) to commit to follow-up assessments


Exclusion Criteria

Neurological:

  • Rapid spontaneous improvement of neurological signs during screening
  • History of stroke or penetrating head injury within 90 days prior to enrollment
  • History of previous or current diagnosis of intracranial hemorrhage (i.e., intracerebral, epidural, subdural or subarachnoid), moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm, or intracranial neoplasm
  • Presence of other neurological or non-neurological co-morbidities (e.g., intracerebral neoplasm, metabolic encephalopathies, hemiplegic migraine, multiple sclerosis, convulsive disorder, monocular blindness) that, in the investigator’s opinion, may lead, independently of the current stroke, to further deterioration in the subject’s neurological status during the trial period, or may render the study’s neurological assessments inconclusive for the purpose of evaluating the effect of investigational product on the stroke
  • Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2

Non-Neurological:

  • Use of oral anticoagulants within 48 hours prior to enrollment
  • Prolonged prothrombin time (INR > 1.7)
  • Prolonged partial thromboplastin time (PTT) that exceeds the upper limit of normal (ULN)
  • Use of heparin within the 48 hours prior to enrollment, except to maintain catheter patency
  • Gastrointestinal, respiratory or urinary tract hemorrhage within 30 days prior to enrollment
  • Major surgery within 30 days prior to enrollment
  • Severe hypertension (systolic blood pressure [BP] > 185 mmHg or diastolic BP > 110 mmHg) or hypotension (systolic BP < 90 mmHg), as measured by at least 2 consecutive supine measurements 10 minutes apart, that does not respond to simple treatment (e.g., 1 dose of labetalol or nicardipine infusion)
  • Estimated glomerular filtration rate (GFR) < 35 mL/min
  • Platelet count < 75,000/mm3
  • Blood glucose concentration <50 mg/dL
  • Prior exposure to any exogenous form of APC [e.g., plasma-derived APC, 3K3A-APC, Xigris,® drotrecogin alfa (activated)]

General:

  • Weight > 129 kg
  • Unable to undergo MRI per local guidelines
  • Pregnant or breastfeeding
  • Current abuse of alcohol or illicit drugs
  • Received treatment with an investigational drug or device within 30 days prior to enrollment
  • Any other condition that, in the opinion of the investigator, may adversely affect the safety of the subject, the subject’s ability to complete the study, or the outcome of the study


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