Status:

TERMINATED

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

Lead Sponsor:

Centocor, Inc.

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Cerebrovascular Accident

Brain Ischemia

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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

Detailed Description

Abciximab is a drug that prevents platelets from sticking together and forming a clot. There are limited studies using abciximab in the treatment of strokes. This phase III, multicenter, randomized, d...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2005

Estimated Enrollment :

808 Patients enrolled

Trial Details

Trial ID

NCT00073372

Start Date

October 1 2003

End Date

December 1 2005

Last Update

May 17 2011

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