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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE November 19, 2003
First Posted Date  ICMJE November 21, 2003
Last Update Posted Date May 17, 2011
Study Start Date  ICMJE October 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
The proportion of modified Rankin Scale responders at 3 months in the primary population.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2010)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke (AbESTT-II)
Official Title  ICMJE Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.
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, 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Cerebrovascular Accident
  • Brain Ischemia
  • Acute Disease
Intervention  ICMJE Drug: Abciximab
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 3, 2010)
808
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
1800
Actual Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Finland,   France,   Germany,   Italy,   Netherlands,   Poland,   Portugal,   South Africa,   Spain,   Switzerland,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00073372
Other Study ID Numbers  ICMJE CR004768
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Centocor, Inc.
Collaborators  ICMJE Eli Lilly and Company
Investigators  ICMJE
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
PRS Account Centocor, Inc.
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP