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

15 februari 2012 uppdaterad av: 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

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Förväntat)

5100

Fas

  • Fas 4

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Zealand University Hospital

Utredare

  • Huvudutredare: 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
  • Studierektor: Gunnar VH Jensen, MD, Zealand University Hospital
  • Studierektor: Jørgen Jeppesen, MD, Glostrup University Hospital, Copenhagen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2012

Primärt slutförande (Förväntat)

1 mars 2020

Avslutad studie (Förväntat)

1 mars 2021

Studieregistreringsdatum

Först inskickad

30 januari 2012

Först inskickad som uppfyllde QC-kriterierna

15 februari 2012

Första postat (Uppskatta)

16 februari 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

16 februari 2012

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 februari 2012

Senast verifierad

1 februari 2012

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • COPERNICOS

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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