Activated Protein C in Acute Stroke Trial

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Drotrecogin alfa activated; Protein C

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)