- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01534221
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
연구 개요
상세 설명
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
연구 유형
등록 (예상)
단계
- 4단계
연락처 및 위치
연구 장소
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Roskilde, 덴마크, 4000
- Roskilde County Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Study group two
Endeavor resolute drug eluting stent
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Biomatrix drug eluting stent
다른 이름들:
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
MACE
기간: 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
기간: Five year
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Definite, propable and possible
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Five year
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Treatment failure
기간: Five Years
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A specifically developed Treatment Failure Classification
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Five Years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Death of any cause
기간: 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.
기간: One and five years
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One and five years
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Cardiac death
기간: One and five years
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One and five years
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Myocardial infarction
기간: One and five years
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One and five years
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Target lesion revascularisation
기간: One and five years
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One and five years
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Target vessel revascularisation
기간: One and five years
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One and five years
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Stent thrombosis
기간: One and five years
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One and five years
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Treatment Failure
기간: One and five years
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One and five years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Anders M Galløe, Md.Ph.D., Zealand University Hospital
- 연구 의자: Steen Carstensen, MD, Zealand University Hospital
- 연구 의자: Ole Havndrup, MD, Zealand University Hospital
- 연구 의자: Lars Kjøller-Hansen, MD, Zealand University Hospital
- 연구 책임자: Gunnar VH Jensen, MD, Zealand University Hospital
- 연구 책임자: Jørgen Jeppesen, MD, Glostrup University Hospital, Copenhagen
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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