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
調査の概要
詳細な説明
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
研究の種類
入学 (予想される)
段階
- フェーズ 4
連絡先と場所
研究場所
-
-
-
Roskilde、デンマーク、4000
- Roskilde County Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Study group two
Endeavor resolute drug eluting stent
|
Biomatrix drug eluting stent
他の名前：
|
|
アクティブコンパレータ：Study group three
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
他の名前：
|
|
アクティブコンパレータ：Study group four
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
他の名前：
|
|
アクティブコンパレータ：Study group five
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
他の名前：
|
|
アクティブコンパレータ：Study group one
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
|
Biomatrix drug eluting stent
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
MACE
時間枠：Five year
|
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
|
Five year
|
|
Stent thromboses
時間枠：Five year
|
Definite, propable and possible
|
Five year
|
|
Treatment failure
時間枠：Five Years
|
A specifically developed Treatment Failure Classification
|
Five Years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Death of any cause
時間枠：One and five years
|
Ongoing quality assurance
|
One and five years
|
|
Self reported health questionnaires on general health and cardiac specific symptoms.
時間枠：One and five years
|
One and five years
|
|
|
Cardiac death
時間枠：One and five years
|
One and five years
|
|
|
Myocardial infarction
時間枠：One and five years
|
One and five years
|
|
|
Target lesion revascularisation
時間枠：One and five years
|
One and five years
|
|
|
Target vessel revascularisation
時間枠：One and five years
|
One and five years
|
|
|
Stent thrombosis
時間枠：One and five years
|
One and five years
|
|
|
Treatment Failure
時間枠：One and five years
|
One and five years
|
協力者と研究者
捜査官
- 主任研究者：Anders M Galløe, Md.Ph.D.、Zealand University Hospital
- スタディチェア：Steen Carstensen, MD、Zealand University Hospital
- スタディチェア：Ole Havndrup, MD、Zealand University Hospital
- スタディチェア：Lars Kjøller-Hansen, MD、Zealand University Hospital
- スタディディレクター：Gunnar VH Jensen, MD、Zealand University Hospital
- スタディディレクター：Jørgen Jeppesen, MD、Glostrup University Hospital, Copenhagen
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。