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

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ClinicalTrials.gov Identifier: NCT00073372
Recruitment Status : Terminated (Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume.)
First Posted : November 21, 2003
Last Update Posted : May 17, 2011
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Centocor, Inc.

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

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Brain Ischemia Acute Disease Drug: Abciximab Phase 3

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 808 participants
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.
Study Start Date : October 2003
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Abciximab
U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073372


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00073372     History of Changes
Other Study ID Numbers: CR004768
First Posted: November 21, 2003    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: June 2010

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

Additional relevant MeSH terms:
Stroke
Ischemia
Brain Ischemia
Acute Disease
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Abciximab
Antibodies, Monoclonal
Immunoglobulin Fab Fragments
Anticoagulants
Platelet Aggregation Inhibitors
Immunologic Factors
Physiological Effects of Drugs