Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy

Phase 2

Terminated

• Conditions: Intracranial Embolism; Cerebral Thromboembolism; Carotid Stenosis
• Interventions: Drug: ARC1779 Injection; Drug: Placebo (normal saline)

• Registration Number: NCT00742612
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Start: 2009-02
• Status Verified: 2009-07
• Primary Completion: 2010-01
• Last Update Submitted: 2010-02-09
• Last Update Posted: 2010-02-10
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ARC1779 Injection	ARC1779 Injection
2	Placebo (normal saline)	Placebo (normal saline)

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To determine the general safety and tolerability of ARC1779 Injection in this surgical population	Up to 7 Days
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 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
To assess laboratory parameters related to ARC1779 pharmacokinetics (PK) and pharmacodynamics (PD)	Up to 7 Days

Trial Locations

Locations (7)

Eddy Scurlock Stroke Center - Methodist Hospital; 🇺🇸 Houston, Texas, United States

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States

Addenbrooke's Hospital, Department of Vascular Surgery; 🇬🇧 Cambridge, United Kingdom

St. George's, University of London, Cranmer Terrace; 🇬🇧 London, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

University Hospital of South Manchester, Wythenshawe Hospital, Southmoor Road; 🇬🇧 Manchester, United Kingdom

University Hospitals Coventry and Warwickshire NHS TRUST; 🇬🇧 Coventry, United Kingdom