The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting - Full Text View

Purpose

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

Condition	Intervention	Phase
Ischemic Heart Disease	Device: Biomatrix drug eluting stent	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Comparison of Outcome of Stenting in Unselected Patients in Everyday Clinical Practice

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:

MACE [ Time Frame: Five year ] [ Designated as safety issue: Yes ]
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
Stent thromboses [ Time Frame: Five year ] [ Designated as safety issue: Yes ]
Definite, propable and possible
Treatment failure [ Time Frame: Five Years ] [ Designated as safety issue: Yes ]
A specifically developed Treatment Failure Classification

Secondary Outcome Measures:

Death of any cause [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]
Ongoing quality assurance
Self reported health questionnaires on general health and cardiac specific symptoms. [ Time Frame: One and five years ] [ Designated as safety issue: No ]
Cardiac death [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]
Myocardial infarction [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]
Target lesion revascularisation [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]
Target vessel revascularisation [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]
Stent thrombosis [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]
Treatment Failure [ Time Frame: One and five years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	5100
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2021
Estimated Primary Completion Date:	March 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Study group two Endeavor resolute drug eluting stent	Device: Biomatrix drug eluting stent Biomatrix drug eluting stent Other Name: 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 Name: 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 Name: 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 Name: 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 Name: Biomatrix

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534221

Contacts

Contact: Anders M Galløe, MD.Ph.D.	+45 47 32 60 22	anders@galloe.dk
Contact: Steen Carstensen, MD.Ph.D.	+45 47 32 60 11	sct@regionsjaelland.dk

Locations

Denmark
Roskilde County Hospital	Not yet recruiting
Roskilde, Denmark, 4000
Contact: Anders M Galløe, MD +45 47 32 60 22 anders@galloe.dk
Contact: Steen Carstensen, MD +45 47 32 60 11 sct@regionsjaelland.dk
Principal Investigator: Anders M Galløe, MD
Sub-Investigator: Steen Carstensen, MD
Sub-Investigator: Ole Havndrup, MD
Sub-Investigator: Lars Kjøller-Hansen, MD

Sponsors and Collaborators

Roskilde County Hospital

Investigators

Principal Investigator:	Anders M Galløe, Md.Ph.D.	Roskilde County Hospital
Study Chair:	Steen Carstensen, MD	Roskilde County Hospital
Study Chair:	Ole Havndrup, MD	Roskilde County Hospital
Study Chair:	Lars Kjøller-Hansen, MD	Roskilde County Hospital
Study Director:	Gunnar VH Jensen, MD	Roskilde County Hospital
Study Director:	Jørgen Jeppesen, MD	Glostrup Hospital

More Information

No publications provided

Responsible Party:	Anders Galloe, Consultant, Roskilde County Hospital
ClinicalTrials.gov Identifier:	NCT01534221 History of Changes
Other Study ID Numbers:	COPERNICOS
Study First Received:	January 30, 2012
Last Updated:	February 15, 2012
Health Authority:	Denmark: National Board of Health

Keywords provided by Roskilde County Hospital:

Ischemic Heart Disease

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease

Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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