Clinical Trial: Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

Brief Summary: 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.

Detailed Summary:
Sponsor: Archemix Corp.

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Archemix Corp.

Dates:
Date Received: August 25, 2008
Date Started: February 2009
Date Completion: April 2010
Last Updated: February 9, 2010
Last Verified: July 2009