Clinical trial NCT01534221: The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting
Official title: Randomized Comparison of Outcome of Stenting in Unselected Patients in Everyday Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ischemic Heart Disease
Keywords: Ischemic Heart Disease
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 5100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: MACE
timeFrame: Five year
measure: Stent thromboses
timeFrame: Five year
measure: Treatment failure
timeFrame: Five Years
Secondary outcomes:
measure: Death of any cause
timeFrame: One and five years
measure: Self reported health questionnaires on general health and cardiac specific symptoms.
timeFrame: One and five years
measure: Cardiac death
timeFrame: One and five years
measure: Myocardial infarction
timeFrame: One and five years
measure: Target lesion revascularisation
timeFrame: One and five years
measure: Target vessel revascularisation
timeFrame: One and five years
measure: Stent thrombosis
timeFrame: One and five years
measure: Treatment Failure
timeFrame: One and five years
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde County Hospital
Study officials:
affiliation: Zealand University Hospital
name: Anders M Galløe, Md.Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital
name: Steen Carstensen, MD
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Ole Havndrup, MD
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Lars Kjøller-Hansen, MD
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Gunnar VH Jensen, MD
role: STUDY_DIRECTOR
affiliation: Glostrup University Hospital, Copenhagen
name: Jørgen Jeppesen, MD
role: STUDY_DIRECTOR
References: