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

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

Study Overview

• Status: Unknown
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Device: Biomatrix drug eluting stent

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 5100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Roskilde, Denmark, 4000
    • Roskilde County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group two; Endeavor resolute drug eluting stent	Device: Biomatrix drug eluting stent; Biomatrix drug eluting stent; Other Names: Biomatrix
Active Comparator: Study group three; The precise selection of brand name depends on negotiations with suppliers and may change during the study period	Device: Biomatrix drug eluting stent; Biomatrix drug eluting stent; Other Names: Biomatrix
Active Comparator: Study group four; The precise selection of brand name depends on negotiations with suppliers and may change during the study period	Device: Biomatrix drug eluting stent; Biomatrix drug eluting stent; Other Names: Biomatrix
Active Comparator: Study group five; The precise selection of brand name depends on negotiations with suppliers and may change during the study period	Device: Biomatrix drug eluting stent; Biomatrix drug eluting stent; Other Names: Biomatrix
Active Comparator: Study group one; The precise selection of brand name depends on negotiations with suppliers and may change during the study period	Device: Biomatrix drug eluting stent; Biomatrix drug eluting stent; Other Names: Biomatrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation	Five year
Stent thromboses	Definite, propable and possible	Five year
Treatment failure	A specifically developed Treatment Failure Classification	Five Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death of any cause	Ongoing quality assurance	One and five years
Self reported health questionnaires on general health and cardiac specific symptoms.		One and five years
Cardiac death		One and five years
Myocardial infarction		One and five years
Target lesion revascularisation		One and five years
Target vessel revascularisation		One and five years
Stent thrombosis		One and five years
Treatment Failure		One and five years

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Anders M Galløe, Md.Ph.D., Zealand University Hospital; Study Chair: Steen Carstensen, MD, Zealand University Hospital; Study Chair: Ole Havndrup, MD, Zealand University Hospital; Study Chair: Lars Kjøller-Hansen, MD, Zealand University Hospital; Study Director: Gunnar VH Jensen, MD, Zealand University Hospital; Study Director: Jørgen Jeppesen, MD, Glostrup University Hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: February 15, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): February 16, 2012
• Last Update Submitted That Met QC Criteria: February 15, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Ischemic Heart Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: COPERNICOS