Michelangelo - Oasis 5
An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes
Study Objectives
PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy.
SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically.
- To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9
- To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9
- To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180
Study Drug: Patients will be randomized to receive either:
- Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or
- Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection
Duration of Therapy:
- Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier)
- Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable.
- Patients should receive an ASA and all other standard medical therapies.
Substudy:
- A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (>48 hrs) coronary angiography and intervention.
Primary Outcome: The first occurence of any component of the following composite up to Day 9:
- Death
- Myocardial Infarction
- Refractory Ischemia
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome.
- Able to randomize within 24 hours of the onset of the most recent episode of symptoms.
- At least one of the following additional criteria: (1) Troponin T of I or CK-MB above the upper limit of normal for the local institution and/or (2) ECG changes compatible with ischemia
- Written informed consent
Exclusion Criteria:
- Age < 21 years
- Any contraindication to low molecular weight heparin
- Hemorrhagic stroke within the last 12 months
- Indication for anticoagulation other than ACS.
- Pregnancy or women of childbearing potential who are not using an effective method of contraception
- Co-morbid condition with life expectancy less than 6 months
- Prior enrollment in one of the fondaparinux ACS trails or currently receiving an experimental pharmacologic agent
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:磺达肝素
|
fondaparinux 2.5 mg, s.c.
injection once daily x 8 days or Hospital Discharge if earlier and placebo-enoxaparin 1mg/kg s.c.
injection twice daily x 2-8 days or until clinically stable
|
有源比较器:依诺肝素
|
enoxaparin 1mg/kg s.c.
injection twice daily x 2 to 8 days
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
death, myocardial infarction or refractory
大体时间:up to and including Day 9
|
first occurrence of any component of death, myocardial infarction or
|
up to and including Day 9
|
major bleeding
大体时间:Up to Day 9
|
incidence of adjudicated major bleeding
|
Up to Day 9
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Death, myocardial infarction or refractory
大体时间:up to Day 9, Day 14, Day 30,
|
Incidence of the individual components of death, myocardial
|
up to Day 9, Day 14, Day 30,
|
major bleeding
大体时间:up to and including Day 14, Day
|
incidence of adjudicated major bleeding
|
up to and including Day 14, Day
|
Any bleeding (major or minor)
大体时间:up to and including Day 9, Day
|
Any bleeding (major or minor) as reported by the investigator as
|
up to and including Day 9, Day
|
Severe bleeding complications
大体时间:up to and including Day 9, Day
|
Severe bleeding complications according to modified thrombolysis in
|
up to and including Day 9, Day
|
Death, myocardial infarction
大体时间:up to Days 9, 14, 30, 90 and
|
composite of death, myocardial infarction
|
up to Days 9, 14, 30, 90 and
|
合作者和调查者
出版物和有用的链接
一般刊物
- Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators; Yusuf S, Mehta SR, Chrolavicius S, Afzal R, Pogue J, Granger CB, Budaj A, Peters RJ, Bassand JP, Wallentin L, Joyner C, Fox KA. Comparison of fondaparinux and enoxaparin in acute coronary syndromes. N Engl J Med. 2006 Apr 6;354(14):1464-76. doi: 10.1056/NEJMoa055443. Epub 2006 Mar 14.
- Chow CK, Jolly S, Rao-Melacini P, Fox KA, Anand SS, Yusuf S. Association of diet, exercise, and smoking modification with risk of early cardiovascular events after acute coronary syndromes. Circulation. 2010 Feb 16;121(6):750-8. doi: 10.1161/CIRCULATIONAHA.109.891523. Epub 2010 Feb 1.
- Bassand JP, Afzal R, Eikelboom J, Wallentin L, Peters R, Budaj A, Fox KA, Joyner CD, Chrolavicius S, Granger CB, Mehta S, Yusuf S; OASIS 5 and OASIS 6 Investigators. Relationship between baseline haemoglobin and major bleeding complications in acute coronary syndromes. Eur Heart J. 2010 Jan;31(1):50-8. doi: 10.1093/eurheartj/ehp401. Epub 2009 Oct 12.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 103420
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
研究数据/文件
-
临床研究报告
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
个人参与者数据集
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
带注释的病例报告表
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
统计分析计划
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
数据集规范
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
研究协议
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
-
知情同意书
信息标识符:103420信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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