This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
(Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume.)
Eli Lilly and Company
Information provided by:
Centocor, Inc. Identifier:
First received: November 19, 2003
Last updated: May 16, 2011
Last verified: June 2010
The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.

Condition Intervention Phase
Cerebrovascular Accident Brain Ischemia Acute Disease Drug: Abciximab Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Resource links provided by NLM:

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • The proportion of modified Rankin Scale responders at 3 months in the primary population.

Secondary Outcome Measures:
  • Proportion of patients with neurological recovery and all-cause mortality at 3 months in the primary population. Fatal intracranial-, nonfatal symptomatic parenchymal-, or other symptomatic intracranial hemorrhages though discharge at day 5 & 3 months

Enrollment: 808
Study Start Date: October 2003
Study Completion Date: December 2005
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, double-blind, placebo-controlled, parallel group study is designed to assess the effectiveness and safety of abciximab for treatment of acute ischemic stroke, in helping dissolve clots in brain arteries so that blood and oxygen can flow better and there may be less brain damage.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. Patients will receive either Abciximab: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 µg/kg/min infusion (to a maximum of 10 µg/min) for 12 hours or a bolus of placebo followed by infusion for 12 hours


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00073372

Sponsors and Collaborators
Centocor, Inc.
Eli Lilly and Company
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

Additional Information:
Publications: Identifier: NCT00073372     History of Changes
Other Study ID Numbers: CR004768
Study First Received: November 19, 2003
Last Updated: May 16, 2011

Keywords provided by Centocor, Inc.:
Acute ischemic stroke
drug safety
drug efficacy
intracranial hemorrhage

Additional relevant MeSH terms:
Brain Ischemia
Acute Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs processed this record on August 22, 2017