NCT00742612终止2 期
A Study of the Effect of ARC1779 Injection on Cerebral Microembolism in Patients Undergoing Carotid Endarterectomy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
1
Active Comparator
ARC1779 Injection
干预措施: ARC1779 Injection (Drug)
2
Placebo Comparator
Placebo (normal saline)
干预措施: Placebo (normal saline) (Drug)
结局指标
主要结局
To determine the effect of ARC1779 Injection on the number of microembolic signals detected by transcranial Doppler (TCD) in the immediate postoperative period
时间窗: Immediate Post-Operative Period
To evaluate the safety of ARC1779 Injection with respect to bleeding risk in patients in the perioperative period.
时间窗: Perioperative Period
次要结局
- 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)
研究者
研究点 (7)
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