The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting (COPERNICOS)
Randomized Comparison of Outcome of Stenting in Unselected Patients in Everyday Clinical Practice
The superiority of a percutaneous coronary intervention (PCI) by one stent over another in terms of clinical outcome is usually documented in large randomized controlled trials (RCT). Although generated from selected study populations these data form the basis for evidence based practice (EBP) in the entire population of patients considered for coronary intervention. An inherent limitation of this approach is that study populations differ significantly from all comers in terms of patient characteristics and prognosis undermining the foundation for extrapolation of trial results to all comers. Furthermore, other trials are based on a "one-fits-all" concept, while the benefits of an "individual-tailored" approach that might be superior, is not investigated.
The Purpose of the current study is to
- Compare clinical outcome between several CE marked drug eluting stents
- Compare clinical outcome between several CE marked bare metal stents
- Compare clinical outcome in all comers with that of the selected study population of RCT's
- Evolve methods to compare clinical outcomes between the generalized "one-fits-all" versus the individualized or "individual-tailored" stent selection approaches
The Method employed is
- All comer PCI registry - single centre
- Randomisation of all eligible patients within the registry to one of several study stent
- Quality assurance in non-randomized population within the registry by periodical alternating the institutional standard stent
- Continuous follow up of all patients included the registry by means of systematic event detection and classification by an independent safety and end point committee
- Assessment of effects on quality of life by heart and health questionnaires
Outcome Measures
Primary endpoints:
- Composite of cardiac death, acute myocardial infraction and target vessel revascularisation
- Stent thrombosis
- A specifically developed Treatment Failure Rate classification
Secondary outcome measures include each of the above, target lesion revascularisation and total death analyzed in a hierarchical fashion at 2, 3, 4 and 5 years.
Tertiary outcome measure is self reported quality of life based on health questionnaires on general health and cardiac symptoms.
Power Calculations An event rate of 20% within 5 years, a relative difference of 25% (an absolute difference of 5%), P< 5%, Power > 80% => 900 patients in each of two treatment arms.
Prespecified Analysis include
- The MACE rates between stent types
- The Stent thrombosis rates between stent types
- The Treatment failure rates between stent types
- The randomized population versus non-randomized population
- The individualized versus the generalized Population
- QOL between stent types
研究概览
详细说明
All MACE and stent thromboses are adjudicated by an independent end point and safety committee chaired by Jørgen Jeppesen known from the very same task he executed in the SORT OUT II.
Further question may be answered by the four key investigators:
Steen Carstensen, Anders Galløe, Ole Havndrup, Lars Kjøller-Hansen
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Roskilde、丹麦、4000
- Roskilde County 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:
- to enter COPERNICOS registry for quality assessment: Each and every patient assigned to percutaneous coronary intervention will be included.
- to enter COPERNICOS randomization: If the patient fulfil the Helsinki declaration and have a Danish personal security identification number they are asked to give written informed consent to participate in the randomized study arms.
Exclusion Criteria to randomization:
- unconscious patients
- residents in other countries thereby escaping event detection
- patients unable to understand the rationale of the study.
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 |
|---|---|
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有源比较器：Study group two
Endeavor resolute drug eluting stent
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Biomatrix drug eluting stent
其他名称：
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有源比较器：Study group three
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
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Biomatrix drug eluting stent
其他名称：
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有源比较器：Study group four
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
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Biomatrix drug eluting stent
其他名称：
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有源比较器：Study group five
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
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Biomatrix drug eluting stent
其他名称：
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有源比较器：Study group one
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
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Biomatrix drug eluting stent
其他名称：
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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 |
|---|---|---|
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MACE
大体时间：Five year
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Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
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Five year
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Stent thromboses
大体时间：Five year
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Definite, propable and possible
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Five year
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Treatment failure
大体时间：Five Years
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A specifically developed Treatment Failure Classification
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Five Years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Death of any cause
大体时间：One and five years
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Ongoing quality assurance
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One and five years
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Self reported health questionnaires on general health and cardiac specific symptoms.
大体时间：One and five years
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One and five years
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Cardiac death
大体时间：One and five years
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One and five years
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Myocardial infarction
大体时间：One and five years
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One and five years
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Target lesion revascularisation
大体时间：One and five years
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One and five years
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Target vessel revascularisation
大体时间：One and five years
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One and five years
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Stent thrombosis
大体时间：One and five years
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One and five years
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Treatment Failure
大体时间：One and five years
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One and five years
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合作者和调查者
调查人员
- 首席研究员：Anders M Galløe, Md.Ph.D.、Zealand University Hospital
- 学习椅：Steen Carstensen, MD、Zealand University Hospital
- 学习椅：Ole Havndrup, MD、Zealand University Hospital
- 学习椅：Lars Kjøller-Hansen, MD、Zealand University Hospital
- 研究主任：Gunnar VH Jensen, MD、Zealand University Hospital
- 研究主任：Jørgen Jeppesen, MD、Glostrup University Hospital, Copenhagen
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
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Biomatrix drug eluting stent的临床试验
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Fondazione Evidence per Attività e Ricerche Cardiovascolari...未知
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Seoul National University Bundang Hospital完全的