Activated Protein C in Acute Stroke Trial "APCAST"


Phase 2 Results N/A

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)