A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
ARC1779 Injection
+ Placebo (normal saline)
Arterial Occlusive Diseases+10
+ Brain Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: February 1, 2009
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Hackensack University Medical Center
Hackensack, United StatesOpen Hackensack University Medical Center in Google MapsEddy Scurlock Stroke Center - Methodist Hospital
Houston, United StatesAddenbrooke's Hospital, Department of Vascular Surgery
Cambridge, United KingdomUniversity Hospitals Coventry and Warwickshire NHS TRUST
Coventry, United Kingdom