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

NCT00073372 ↗

Phase 3 Terminated 808 enrolled Centocor, Inc. Eli Lilly and Company · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2003-10
Primary completion: —
Completion: 2005-12

Outcome

Missed primary endpoint

Stopped (Enrollment): “Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume.”

paper 32% of patients assigned abciximab (71/221; P=0.944) in the primary cohort PMID 18032739 ↗

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abciximab	Monoclonal antibody	0.125 ug/kg	Intravenous