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

Cerebrovascular Accident Clinical Trial

Official title:

Abciximab (ReoPro) in Acute Ischemic Stroke: A Phase III, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00073372
• Other study ID #: CR004768
• Status: Terminated
• Phase: Phase 3
• First received: November 19, 2003
• Last updated: May 16, 2011
• Start date: October 2003
• Est. completion date: December 2005

Study information

• Verified date: June 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness of abciximab in the treatment of acute ischemic stroke.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 808
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• Brain Ischemia
• Cerebrovascular Accident
• Stroke

Intervention

Drug:
• Abciximab

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centocor, Inc.	Eli Lilly and Company

References & Publications (1)

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 interna — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of modified Rankin Scale responders at 3 months in the primary population.
Secondary	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

External Links

•   Abciximab (ReoPro?) in Acute Ischemic Stroke: A Phase 3, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Trial