The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting

Ischemic Heart Disease Clinical Trial

— COPERNICOS  

Official title:

Randomized Comparison of Outcome of Stenting in Unselected Patients in Everyday Clinical Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01534221
• Other study ID #: COPERNICOS
• Status: Not yet recruiting
• Phase: Phase 4
• First received: January 30, 2012
• Last updated: February 15, 2012
• Start date: March 2012
• Est. completion date: March 2021

Study information

• Verified date: February 2012
• Source: Roskilde County Hospital
• Contact: Anders M Galløe, MD.Ph.D.
• Phone: +45 47 32 60 22
• Email: anders[@]galloe.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5100
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Biomatrix drug eluting stent
Biomatrix drug eluting stent

Locations

Country	Name	City	State
Denmark	Roskilde County Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE	Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation	Five year	Yes
Primary	Stent thromboses	Definite, propable and possible	Five year	Yes
Primary	Treatment failure	A specifically developed Treatment Failure Classification	Five Years	Yes
Secondary	Death of any cause	Ongoing quality assurance	One and five years	Yes
Secondary	Self reported health questionnaires on general health and cardiac specific symptoms.		One and five years	No
Secondary	Cardiac death		One and five years	Yes
Secondary	Myocardial infarction		One and five years	Yes
Secondary	Target lesion revascularisation		One and five years	Yes
Secondary	Target vessel revascularisation		One and five years	Yes
Secondary	Stent thrombosis		One and five years	Yes
Secondary	Treatment Failure		One and five years	Yes