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. )

First Received on November 19, 2003. Last Updated on May 16, 2011 History of Changes

Sponsor:	Centocor, Inc.
Collaborator:	Eli Lilly and Company
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00073372

Purpose

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

Drug Information available for: Abciximab

U.S. FDA Resources

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00073372

Sponsors and Collaborators

Centocor, Inc.

Eli Lilly and Company

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Additional Information:

Abciximab (ReoPro�) in Acute Ischemic Stroke: A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Adams HP Jr, Effron MB, Torner J, Dávalos A, Frayne J, Teal P, Leclerc J, Oemar B, Padgett L, Barnathan ES, Hacke W; AbESTT-II Investigators. Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of an international phase III trial: Abciximab in Emergency Treatment of Stroke Trial (AbESTT-II). Stroke. 2008 Jan;39(1):87-99. Epub 2007 Nov 21.

ClinicalTrials.gov Identifier:	NCT00073372 History of Changes
Other Study ID Numbers:	CR004768
Study First Received:	November 19, 2003
Last Updated:	May 16, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Acute ischemic stroke
abciximab
ReoPro
drug safety

drug efficacy
intracranial hemorrhage
stroke

Additional relevant MeSH terms:

Acute Disease
Brain Ischemia
Ischemia
Cerebral Infarction
Stroke
Disease Attributes
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Abciximab
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants

ClinicalTrials.gov processed this record on February 12, 2012