Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (BASE-ACS)
Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)
研究概览
详细说明
The BASE-ACS trial is an academic study, which will be conceived and conducted as a multicenter (multi-country) study by experienced interventional cardiologists. This study is independent of commercial interests.
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (Titan-2®) and everolimus-eluting stent (Xience V®, Promus®) in patients presenting with acute coronary syndrome.
A total of 850 patients will be included in the randomized study. The primary end point (MACE) is the composite of cardiac death, myocardial infarction and target lesion revascularization during 12 months of follow-up. Enrollment of patients will start in November 2008 and end in 2009.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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-
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Helsinki、芬兰
- Helsinki University Hospital
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Jyvaskyla、芬兰
- Jyväskylä Central Hospital
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Kokkola、芬兰
- Keski-Pohjanmaan Keskusairaala
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Oulu、芬兰、90100
- Oulu University Hospital
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Pori、芬兰、28500
- Satakunta Central Hospital
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Turku、芬兰
- Turku University Hospital
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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:
- All patients presenting with acute coronary syndrome (unstable angina, non-st-elevation myocardial infarction or st-elevation myocardial infarction)and undergoing percutaneous coronary intervention
- Written informed consent
Exclusion Criteria:
- Age < 18 years
- Expected survival < 1 year
- Allergy to aspirin, clopidogrel or ticlopidine
- Allergy to heparins, glycoprotein IIb/IIIa inhibitors or bivalirudin
- Allergy to everolimus
- Active bleeding or significant increased risk of bleeding
- Stent length longer than 28 mm needed
- Stent diameter > 4.0 mm needed
- Thrombolysis therapy
- Planned surgery within 12 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Patients receiving bio-active stent during the intervention
|
Intra-coronary stenting
其他名称：
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有源比较器：2
Patients receiving everolimus-eluting stent during the intervention
|
Intra-coronary stenting
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 12 months of follow-up.
大体时间：12 months
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12 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
All cause death, cardiac death, MI, stent thrombosis and TLR at 1, 6, 12 and 18 months, and at 2, 3, 4 and 5 years.
大体时间：5 years
|
5 years
|
合作者和调查者
调查人员
- 首席研究员：Pasi P Karjalainen, MD, PhD、Satakunta Central Hospital, Pori, Finland
- 首席研究员：Antti Ylitalo, MD, PhD、Satakunta Central Hospital, Pori, Finland
- 首席研究员：Matti Niemela, MD, PhD、Oulu University Hospital
- 首席研究员：Juhani KE Airaksinen, Professor、Turku University Hospital, Turku, Finland
- 首席研究员：Otto Hess, Professor、Bern University Hospital, Bern, Switzerland
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
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
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