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
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident Brain Ischemia Acute Disease||Drug: Abciximab||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Official Title:||Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.|
|Study Start Date :||October 2003|
|Actual Study Completion Date :||December 2005|
- The proportion of modified Rankin Scale responders at 3 months in the primary population.
- 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
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
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|