NCT01020383已完成2 期
A Phase 2 Randomized, Open Label Clinical Trial in High Risk Percutaneous Coronary Intervention (PCI) Patients Receiving Standard Antithrombotic Treatment Plus Either ALX-0081 or GPIIb/IIIa Inhibitor (ReoPro®) Over a Period of 24 Hours
Ablynx, a Sanofi company0 个研究点目标入组 364 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 主要终点
- Incidence and severity of bleeding classified by the following criteria: TIMI major bleeding events, TIMI minor bleeding events, bleeding events requiring medical attention, defined as TIMI minimal bleeding events
研究概览
简要总结
This is a multicenter, randomized and open-label Phase II study to compare the safety, tolerability and biological effectiveness of ALX-0081 versus the GPIIb/IIIa inhibitor ReoPro® in high risk PCI patients.
Patients will receive standard treatment with acetylsalicylic acid (ASA) plus clopidogrel and heparin. Eligible patients will be randomly assigned to receive open-label study treatment with either ALX-0081 or ReoPro®. Patients will be stratified according to PCI type (elective or ad-hoc) and stent type (bare metal stent or drug eluting stent).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have unstable angina or NSTEMI,or stable angina with at least 2 factors indicating a high risk PCI as follows: patient related: diabetic patients, renal failure (glomerular filtration rate < 60), reduced left ventricular ejection fraction < 35%, age > 75 years, female gender and/or lesion/anatomy related: SYNTAX score > 26, bifurcation lesions, multi-vessel disease, intracoronary thrombus.
- •Adequate hematological function including platelets > 100000/mm
- •Body mass index (BMI) ≥18 kg/m2 and ≤ 35 kg/m
- •Aged ≥ 18 years old.
- •Women of childbearing potential must be practicing a medically acceptable contraceptive regimen. Only males who do not want to father children during the study and in the first 4 months after treatment may be included in the study. During this period, safe contraception is mandatory. Male patients who are sexually active must use a condom during intercourse and ensure that the female partner uses a reliable contraceptive method, or they must refrain from sexual intercourse during the first 4 months after treatment.
- •Patients must be accessible for follow-up.
- •Have a sufficient command to read and understand all instructions necessary for giving informed consent and participating in the study.
- •Have signed and dated written informed consent prior to any study-related procedures.
排除标准
- •Previous (within 30 days) treatment with GPIIb/IIIa inhibitors (such as ReoPro®).
- •ST-elevation myocardial infarction (STEMI).
- •Chronic total occlusion of a coronary artery.
- •Scheduled rotablator procedure.
- •PCI of the arterial or venous by-pass graft.
- •Any contra-indication for ReoPro®.
- •Major organ dysfunction, infection or any serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
- •Known hypersensitivity to human/humanized antibodies.
- •Women who are pregnant or lactating.
- •Dementia or significantly altered mental status that would prohibit understanding the study procedures and giving informed consent.
- •Use of vitamin K antagonists and/or Factor Xa inhibitors within 4 weeks prior to admission to the Hospital Intensive Care Unit.
- •Use of GPIIa/IIIb inhibitors other than ReoPro®; prasugrel, bivalirudin and fondaparinux prior to and throughout the study.
- •Known history of acquired or congenital bleeding disorder, coagulopathy or platelet disorder.
- •Evidence of active pathological bleeding at screening or history of clinically significant bleeding (such as gastrointestinal or genitourinary) within the last 6 months prior to screening visit, unless the cause has been definitely corrected
- •History of intracranial bleeding (e.g. hemorrhagic stroke, subdural hematoma, subarachnoid hemorrhage) or history of hemorrhagic retinopathy.
- •History of ischemic stroke or TIA, within the past year prior to screening or known structural cerebral vascular lesion (e.g. arteriovenous malformation, aneurysm).
- •History of New York Heart Association class III or IV congestive heart failure or history of severe, uncontrolled cardiac arrhythmias at screening.
- •Planned elective surgical operation or major invasive procedures or traumas from 30 days prior to screening to completion of the study at Day 30 (the decision of what constitutes a major invasive procedure or trauma will be at the discretion of the investigator in conjunction with review and approval by the Medical Monitor).
- •Use of another investigational drug or device within previous 30 days (12 weeks for investigational devices, e.g. unapproved stents) prior to screening.
研究组 & 干预措施
ALX-0081
Experimental
干预措施: ALX-0081 (Drug)
GPIIb/IIIa inhibitor
Active Comparator
干预措施: ReoPro® (Drug)
结局指标
主要结局
Incidence and severity of bleeding classified by the following criteria: TIMI major bleeding events, TIMI minor bleeding events, bleeding events requiring medical attention, defined as TIMI minimal bleeding events
时间窗: 30 days
次要结局
未报告次要终点
研究者
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