A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II)

• Status: Terminated
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Collaborator: Eli Lilly and Company
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Patients with diagnosis of acute ischemic stroke with onset within 5 hours and 30 minutes before randomization and planned treatment initiation within 6 hours of onset

• After 600 patients are enrolled in previous criteria, the new criteria for enrollment will be, patients with diagnosis of acute ischemic stroke with onset within 4 hours and 30 minutes before randomization and planned treatment initiation within 5 hours of onset

Exclusion Criteria:

• Patients who had participation in another study with an investigational drug or device within the last 30 days, prior participation in the present study, or planned participation in another trial

• Patients with symptoms suggestive of subarachnoid hemorrhage

• Female patients known to be pregnant, lactating, or having a positive or indeterminate pregnancy test

• Patients with neurological deficit that has led to stupor or coma

• Patients with minor stroke