Ischemic Heart DiseasePhase 4COPERNICOSNCT01534221
The COOPerative Establishment for Necessary Investigation in Clinical Outcome After Stenting
A Phase 4 study testing Biomatrix drug eluting stent in people with Ischemic Heart Disease, run by Zealand University Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Biomatrix drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,100 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- unconscious patients
- residents in other countries thereby escaping event detection
- patients unable to understand the rationale of the study.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Roskilde County Hospital
Roskilde, 4000
Anders M Galløe, MD, +45 47 32 60 22, anders@galloe.dk
Steen Carstensen, MD, +45 47 32 60 11, sct@regionsjaelland.dk
About this study
Official title: 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
Read more
- 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
Read the 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
- Conditions
- Ischemic Heart Disease
- Being tested
- Biomatrix drug eluting stent
- Keywords
- Ischemic Heart Disease
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomatrix drug eluting stentDevice
Also called Biomatrix
Biomatrix drug eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Study group two | Active comparator | Endeavor resolute drug eluting stent Receives: Device: Biomatrix drug eluting stent |
| Study group three | Active comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period Receives: Device: Biomatrix drug eluting stent |
| Study group four | Active comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period Receives: Device: Biomatrix drug eluting stent |
| Study group five | Active comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period Receives: Device: Biomatrix drug eluting stent |
| Study group one | Active comparator | The precise selection of brand name depends on negotiations with suppliers and may change during the study period Receives: Device: Biomatrix drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
Measured: Five year
Stent thromboses
Definite, propable and possible
Measured: Five year
Treatment failure
A specifically developed Treatment Failure Classification
Measured: Five Years
Secondary outcomes (8)
Death of any cause
Ongoing quality assurance
Measured: One and five years
Self reported health questionnaires on general health and cardiac specific symptoms.
Measured: One and five years
Cardiac death
Measured: One and five years
Myocardial infarction
Measured: One and five years
Target lesion revascularisation
Measured: One and five years
Target vessel revascularisation
Measured: One and five years
Stent thrombosis
Measured: One and five years
Treatment Failure
Measured: One and five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Galloe, Zealand University Hospital
- Investigators
- Anders M Galløe, Md.Ph.D., Principal investigator, Zealand University HospitalSteen Carstensen, MD, Study chair, Zealand University HospitalOle Havndrup, MD, Study chair, Zealand University HospitalLars Kjøller-Hansen, MD, Study chair, Zealand University HospitalGunnar VH Jensen, MD, Study director, Zealand University HospitalJørgen Jeppesen, MD, Study director, Glostrup University Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534221
- Sponsor's protocol ID
- COPERNICOS
- Acronym
- COPERNICOS
- Status last verified
- Feb 2012
- First submitted
- 30 Jan 2012
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Outcome of Stenting in Unselected Patients in Everyday Clinical Practice
- ClinicalTrials.gov ID
- NCT01534221
- Acronym / sponsor ID
- COPERNICOS / COPERNICOS
- Conditions
- Ischemic Heart Disease
- Keywords
- Ischemic Heart Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,100 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Study group two | Active comparator | Device: Biomatrix drug eluting stentEndeavor resolute drug eluting stent |
| Study group three | Active comparator | Device: Biomatrix drug eluting stentThe precise selection of brand name depends on negotiations with suppliers and may change during the study period |
| Study group four | Active comparator | Device: Biomatrix drug eluting stentThe precise selection of brand name depends on negotiations with suppliers and may change during the study period |
| Study group five | Active comparator | Device: Biomatrix drug eluting stentThe precise selection of brand name depends on negotiations with suppliers and may change during the study period |
| Study group one | Active comparator | Device: Biomatrix drug eluting stentThe precise selection of brand name depends on negotiations with suppliers and may change during the study period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- unconscious patients
- residents in other countries thereby escaping event detection
- patients unable to understand the rationale of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomatrix drug eluting stentAlso: BiomatrixBiomatrix drug eluting stent | Device | Study group five, Study group four, Study group one, Study group three, Study group two |
Primary outcome
MACE
Time frame: Five year
Major adverse cardiac events defined as a composite of cardiac death, acute myocardial infraction and target vessel revascularisation
Stent thromboses
Time frame: Five year
Definite, propable and possible
Treatment failure
Time frame: Five Years
A specifically developed Treatment Failure Classification
8 secondary outcomes
Death of any cause
Time frame: One and five years
Self reported health questionnaires on general health and cardiac specific symptoms.
Time frame: One and five years
Cardiac death
Time frame: One and five years
Myocardial infarction
Time frame: One and five years
Target lesion revascularisation
Time frame: One and five years
Target vessel revascularisation
Time frame: One and five years
Stent thrombosis
Time frame: One and five years
Treatment Failure
Time frame: One and five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders M Galløe, Md.Ph.D. principal investigator
Zealand University Hospital
Steen Carstensen, MD study chair
Zealand University Hospital
Ole Havndrup, MD study chair
Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biomatrix drug eluting stent in people with Ischemic Heart Disease, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anders M Galløe, MD.Ph.D. (+45 47 32 60 22, anders@galloe.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: Five year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.