Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073372
Status:
TERMINATED
Last Update Posted:
2011-05-17
First Post:
2003-11-19
Brief Title:
A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke AbESTT-II
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
Abciximab ReoPro in Acute Ischemic Stroke A Phase III Multinational Multicenter Randomized Double-blind Placebo-controlled Trial
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Based on the data and observed benefit-risk profile the trials independent oversight committee recommended that enrollment not resume
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 025 mgkg bolus to a maximum of 30 mg followed by a 0125 µgkgmin infusion to a maximum of 10 µgmin for 12 hours or a bolus of placebo followed by infusion for 12 hours
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 025 mgkg bolus to a maximum of 30 mg followed by a 0125 µgkgmin infusion to a maximum of 10 µgmin for 12 hours or a bolus of placebo followed by infusion for 12 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None