EUCTR2005-004901-27-DK进行中（未招募）不适用
A Phase 3, Multicenter, Multi-national, Randomized, Double-Blind, Placebo-Controlled study to Evaluate the Efficacy and Safety of Alfimeprase in Subjects with Acute Peripheral Arterial Occlusion (NAPA-3).
uvelo0 个研究点目标入组 300 人开始时间: 2006年2月21日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •a) The subject (or legally acceptable representative) must give written informed consent
- •b) Age 18 years or older
- •c) Arteriographically confirmed acute PAO of the lower extremity with onset of symptoms within 14 days prior to randomization
- •d) Acute index limb ischemia classified as SVS/ISCVS Class I or IIA caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). Only Class I subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible.
- •e) Acute PAO with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy
- •f) Available for follow-up assessments
- •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
排除标准
- •a) Contraindication to systemic anticoagulation e.g., history of documented hemorrhage requiring treatment within the past 30 days; history of a hereditary bleeding disorder or known bleeding diathesis, major surgery or trauma, open chest massage, ocular surgery or hemorrhagic retinopathy within the past 30 days; puncture at non-compressible site within 48 hours prior to administration of study drug; and history of stroke, intracranial hemorrhage, or central nervous system structural abnormalities within the past 3 months
- •b) History of endovascular procedure or open vascular surgery on the index limb within the last 30 days
- •c) History of significant acute or chronic kidney disease that would preclude contrast angiography
- •d) Known allergy to contrast agents
- •e) History of heparin-induced thrombocytopenia (HIT)
- •f) Participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization
- •g) Any thrombolytic therapy within 5 days prior to randomization
- •h) Past participation in any alfimeprase clinical trial
- •i) Pregnant, lactating, or actively menstruating women and women o child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator)
- •j) Investigator inability to advance guidewire through index occlusion
- •k) Any other subject feature that in the opinion of the investigator should preclude study participation
研究者
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