Study Stopped
Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume.
A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II)
Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.
1 other identifier
interventional
808
0 countries
N/A
Brief Summary
The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 19, 2003
CompletedFirst Posted
Study publicly available on registry
November 21, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedMay 17, 2011
June 1, 2010
November 19, 2003
May 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of modified Rankin Scale responders at 3 months in the primary population.
Secondary Outcomes (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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
- Eli Lilly and Companycollaborator
Related Publications (1)
Adams HP Jr, Effron MB, Torner J, Davalos 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. doi: 10.1161/STROKEAHA.106.476648. Epub 2007 Nov 21.
PMID: 18032739RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 19, 2003
First Posted
November 21, 2003
Study Start
October 1, 2003
Study Completion
December 1, 2005
Last Updated
May 17, 2011
Record last verified: 2010-06