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

Archemix Corp.0 个研究点目标入组 100 人开始时间: 2008年10月23日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Inclusion Criteria
•Male or female patients;
•18 to 85 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Exclusion Criteria
•Lack of acoustic window allowing TCD recordings;
•Unable or unwilling to consent;
•Medical condition unsuitable for planned carotid endarterectomy surgery;
•Metallic prosthetic cardiac valve;
•Recent (<4 weeks) ischemic stroke involving >1/3 of the middle cerebral artery
•(MCA) territory;
•Any history of hemorrhagic stroke;
•Thrombocytopenia;
•Coagulopathy;
•Recent or current bleeding disorder or other medical problem associated with an
•increased risk of bleeding;
•Trauma or surgery within preceding 30 days;
•Use of warfarin or 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 glycoprotein (GP) IIb/IIIa inhibitor treatment within the preceding 24

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