Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

February 9, 2010 updated by: Archemix Corp.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrooke's Hospital, Department of Vascular Surgery
      • Coventry, United Kingdom, CV2 2DX
        • University Hospitals Coventry and Warwickshire NHS Trust
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • London, United Kingdom, SW17 ORE
        • St. George's, University of London, Cranmer Terrace
      • Manchester, United Kingdom, M23 9LT
        • University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road
  • United States
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Eddy Scurlock Stroke Center - Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients;
  • >/= 18 to </= 80 years of age;
  • Carotid stenosis (either symptomatic or asymptomatic);
  • Planned carotid endarterectomy;
  • Female patients must be non-pregnant and willing to use effective, redundant methods of contraception (i.e., for both self and male partner) throughout the study and for at least 30 days after discontinuation of study drug treatment;
  • Male patients must agree to use a medically acceptable contraceptive (abstinence or use of a condom with spermicide) throughout the study and for at least 30 days after discontinuation of study drug treatment;
  • All patients must be capable of understanding and complying with the protocol and must have signed the informed consent document.

Exclusion Criteria:

  • Lack of acoustic window allowing TCD recordings;
  • Unable or unwilling to consent;
  • Metallic prosthetic cardiac valve;
  • Recent (<4 weeks) ischemic stroke involving >1/3 of the MCA territory;
  • Any history of hemorrhagic stroke;
  • Thrombocytopenia;
  • Coagulopathy;
  • Trauma or surgery within preceding 30 days;
  • History of bleeding disorder, gastrointestinal ulcers, or other medical problem associated with an increased risk of bleeding;
  • Use of warfarin and any chronic antithrombotic therapy other than acetylsalicylic acid and/or dipyridamole; patients previously treated with warfarin are eligible if the drug has been discontinued and the INR prior to randomization has returned to <1.3;
  • Use of clopidogrel, unless it has been discontinued at least 5 days prior to randomization;
  • Fibrinolytic or GPIIb/IIIa inhibitor treatment within the preceding 24 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
ARC1779 Injection
Drug: 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 Comparator: 2
Placebo (normal saline)
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Perioperative Period

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Up to 7 Days
To determine the general safety and tolerability of ARC1779 Injection in this surgical population
Time Frame: Up to 7 Days
Up to 7 Days
To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD)
Time Frame: Up to 7 Days
Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism
Time Frame: Up to 7 Days
Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and safety parameters.
Time Frame: Up to 7 Days
Up to 7 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Archemix Corp.

Collaborators

St George's, University of London

Investigators

  • Principal Investigator: Hugh Markus, MD, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Anticipated)

April 1, 2010

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (Estimate)

August 27, 2008

Study Record Updates

Last Update Posted (Estimate)

February 10, 2010

Last Update Submitted That Met QC Criteria

February 9, 2010

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC1779-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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