100
Participants
Start Date
February 28, 2009
Primary Completion Date
January 31, 2010
Study Completion Date
April 30, 2010
ARC1779 Injection
Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The ARC1779 treatment group will be dosed to achieve a target ARC1779 steady-state plasma concentration of 3 Ug/mL, using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min.
Placebo (normal saline)
Study drug treatment will be initiated 1 hour prior to the induction of anesthesia with a loading dose given over 1 hour in 3 successively increasing, 20-minute step infusions. The placebo group will be dosed to a steady-state plasma concentration using a loading dose infusion sequence of 0.0015 mg/kg/min for 20 minutes, 0.003 mg/kg/min for the next 20 minutes, and then 0.006 mg/kg/min for the final 20 minutes; thereafter, their maintenance infusion rate is to be 0.0006 mg/kg/min.
Eddy Scurlock Stroke Center - Methodist Hospital, Houston
Hackensack University Medical Center, Hackensack
Addenbrooke's Hospital, Department of Vascular Surgery, Cambridge
University Hospitals Coventry and Warwickshire NHS TRUST, Coventry
Leeds General Infirmary, Leeds
St. George's, University of London, Cranmer Terrace, London
University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road, Manchester
Lead Sponsor
St George's, University of London
OTHER
Archemix Corp.
INDUSTRY