Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

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

Sponsors

Lead Sponsor: Archemix Corp.

Collaborator: St George's, University of London

Source Archemix Corp.
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.

Overall Status Terminated
Start Date 2009-02-01
Completion Date 2010-04-01
Primary Completion Date 2010-01-01
Phase Phase 2
Study Type Interventional
Primary 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 Immediate Post-Operative Period
To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period. Perioperative Period
Secondary 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 Up to 7 Days
To determine the general safety and tolerability of ARC1779 Injection in this surgical population Up to 7 Days
To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD) Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and the frequency of cerebral microembolism Up to 7 Days
To assess the relationships among ARC1779 PD, PK, and safety parameters. Up to 7 Days
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: ARC1779 Injection

Description: 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.

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: Placebo (normal saline)

Description: 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.

Arm Group Label: 2

Eligibility

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hugh Markus, MD Principal Investigator St George's, University of London
Location
Facility:
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States
Eddy Scurlock Stroke Center - Methodist Hospital | Houston, Texas, 77030, United States
Addenbrooke's Hospital, Department of Vascular Surgery | Cambridge, CB2 0QQ, United Kingdom
University Hospitals Coventry and Warwickshire NHS TRUST | Coventry, CV2 2DX, United Kingdom
Leeds General Infirmary | Leeds, LS1 3EX, United Kingdom
St. George's, University of London, Cranmer Terrace | London, SW17 ORE, United Kingdom
University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road | Manchester, M23 9LT, United Kingdom
Location Countries

United Kingdom

United States

Verification Date

2009-07-01

Responsible Party

Name Title: James Gilbert, MD./Chief Medical Officer

Organization: Archemix Corp.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Active Comparator

Description: ARC1779 Injection

Label: 2

Type: Placebo Comparator

Description: Placebo (normal saline)

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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