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The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting (COPERNICOS)

15. februar 2012 opdateret af: Anders Galloe, Zealand University Hospital

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

  1. The MACE rates between stent types
  2. The Stent thrombosis rates between stent types
  3. The Treatment failure rates between stent types
  4. The randomized population versus non-randomized population
  5. The individualized versus the generalized Population
  6. QOL between stent types

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

5100

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Danmark
      • Roskilde, Danmark, 4000
        • Roskilde County Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Study group two
Endeavor resolute drug eluting stent
Enhed: Biomatrix drug eluting stent
Biomatrix drug eluting stent
Andre navne:
  • Biomatrix
Aktiv komparator: Study group three
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Enhed: Biomatrix drug eluting stent
Biomatrix drug eluting stent
Andre navne:
  • Biomatrix
Aktiv komparator: Study group four
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Enhed: Biomatrix drug eluting stent
Biomatrix drug eluting stent
Andre navne:
  • Biomatrix
Aktiv komparator: Study group five
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Enhed: Biomatrix drug eluting stent
Biomatrix drug eluting stent
Andre navne:
  • Biomatrix
Aktiv komparator: Study group one
The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Enhed: Biomatrix drug eluting stent
Biomatrix drug eluting stent
Andre navne:
  • Biomatrix

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MACE
Tidsramme: Five year
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
Five year
Stent thromboses
Tidsramme: Five year
Definite, propable and possible
Five year
Treatment failure
Tidsramme: Five Years
A specifically developed Treatment Failure Classification
Five Years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Death of any cause
Tidsramme: One and five years
Ongoing quality assurance
One and five years
Self reported health questionnaires on general health and cardiac specific symptoms.
Tidsramme: One and five years
One and five years
Cardiac death
Tidsramme: One and five years
One and five years
Myocardial infarction
Tidsramme: One and five years
One and five years
Target lesion revascularisation
Tidsramme: One and five years
One and five years
Target vessel revascularisation
Tidsramme: One and five years
One and five years
Stent thrombosis
Tidsramme: One and five years
One and five years
Treatment Failure
Tidsramme: One and five years
One and five years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zealand University Hospital

Efterforskere

  • Ledende efterforsker: Anders M Galløe, Md.Ph.D., Zealand University Hospital
  • Studiestol: Steen Carstensen, MD, Zealand University Hospital
  • Studiestol: Ole Havndrup, MD, Zealand University Hospital
  • Studiestol: Lars Kjøller-Hansen, MD, Zealand University Hospital
  • Studieleder: Gunnar VH Jensen, MD, Zealand University Hospital
  • Studieleder: Jørgen Jeppesen, MD, Glostrup University Hospital, Copenhagen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2012

Primær færdiggørelse (Forventet)

1. marts 2020

Studieafslutning (Forventet)

1. marts 2021

Datoer for studieregistrering

Først indsendt

30. januar 2012

Først indsendt, der opfyldte QC-kriterier

15. februar 2012

Først opslået (Skøn)

16. februar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. februar 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2012

Sidst verificeret

1. februar 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COPERNICOS

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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