Status:
TERMINATED
Effect of ARC1779 on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
Lead Sponsor:
Archemix Corp.
Collaborating Sponsors:
St George's, University of London
Conditions:
Intracranial Embolism
Cerebral Thromboembolism
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 immedia...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00742612
Start Date
February 1 2009
End Date
April 1 2010
Last Update
February 10 2010
Active Locations (7)
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1
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
2
Eddy Scurlock Stroke Center - Methodist Hospital
Houston, Texas, United States, 77030
3
Addenbrooke's Hospital, Department of Vascular Surgery
Cambridge, United Kingdom, CB2 0QQ
4
University Hospitals Coventry and Warwickshire NHS TRUST
Coventry, United Kingdom, CV2 2DX