The purpose of this study is to determine, in patients undergoing carotid endarterectomy, the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler immediately after surgery. This study will also evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the peri-operative (during surgery) period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
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.
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.
Hackensack University Medical Center
Hackensack, New Jersey, United States
Eddy Scurlock Stroke Center - Methodist Hospital
Houston, Texas, United States
Addenbrooke's Hospital, Department of Vascular Surgery
Cambridge, United Kingdom
University Hospitals Coventry and Warwickshire NHS TRUST
To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period
Time frame: Immediate Post-Operative Period
To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period.
Time frame: Perioperative Period
To determine the effect of ARC1779 on the incidence of new ischemic lesions detectable with diffusion-weighted magnetic resonance imaging (MRI) after carotid endarterectomy
Time frame: Up to 7 Days
To determine the general safety and tolerability of ARC1779 Injection in this surgical population
Time frame: Up to 7 Days
To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD)
Time frame: Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism
Time frame: Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and safety parameters.
Time frame: Up to 7 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Coventry, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
St. George's, University of London, Cranmer Terrace
London, United Kingdom
University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road
Manchester, United Kingdom