The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting

Phase 4

• Conditions: Ischemic Heart Disease
• Interventions: Device: Biomatrix drug eluting stent

• Registration Number: NCT01534221
• Lead Sponsor: Zealand University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2012-01-30
• Status Verified: 2012-02
• Study First Submitted QC: 2012-02-15
• Last Update Submitted: 2012-02-15
• Study First Posted: 2012-02-16
• Last Update Posted: 2012-02-16
• Study Start: 2012-03
• Primary Completion: 2020-03
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5100

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group two	Biomatrix drug eluting stent	Endeavor resolute drug eluting stent
Study group three	Biomatrix drug eluting stent	The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Study group four	Biomatrix drug eluting stent	The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Study group five	Biomatrix drug eluting stent	The precise selection of brand name depends on negotiations with suppliers and may change during the study period
Study group one	Biomatrix drug eluting stent	The precise selection of brand name depends on negotiations with suppliers and may change during the study period

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Death of any cause	One and five years	Ongoing quality assurance
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

Trial Locations

Locations (1)

Roskilde County Hospital; 🇩🇰 Roskilde, Denmark