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Coronary Artery DiseasePhase 4COMPARE-IINCT01233453

Comparison of the Everolimus Eluting With the Biolimus A9 Eluting Stent

A Phase 4 study testing the everolimus eluting ® stent and the Biolimus A9 eluting NOBORI® stent in people with Coronary Artery Disease, run by Maasstad Hospital at 11 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI®… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
the everolimus eluting ® stent and the Biolimus A9 eluting NOBORI® stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,700 participants
Where
11 sitesin 4 countries
Study dates
Jan 2009to Dec 2015
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

  • The patient is at least 18 years old and has a life expectancy of 5 years.
  • Patient undergoes a PCI procedure for indications according to the Dutch and European guidelines
  • Patient is willing to comply with the extended follow-up period of 2 to 5 years(for secondary endpoint only)
  • Reference lumen diameter of the treated vessels between 2.0 - 4.0 mm.
  • Informed consent

Who cannot join

  • Expected non-adherence to dual antiplatelet therapy for 1 year (e.g: known allergy to ASA or thienopyridines like clopidogrel)
  • Expected major surgery within 30 days (these patients will receive bare metal stents)
  • Cardiogenic shock (Kilip class 4)
  • Previous PCI procedures with implantation of drug eluting stents within 1 year.
  • Expected loss for follow up
  • Enrollment in an investigative stent study with different stents
  • Inability to implant Nobori or Xience-V / Promus stent(s)

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

Netherlands4 sites

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • Amphia Ziekenhuis

    Breda

  • Medisch Centrum Leeuwarden

    Leeuwarden

  • Maasstad Hospital

    Rotterdam

Other trials in Netherlands

Spain4 sites

  • Complejo Hospitalario Universitario Juan Canalejo

    A Coruña

  • Hospital del Mar

    Barcelona

  • Hospital Universitario Virgen Arrixaca

    Murcia

  • Hospital Clinico universitario de Santiago de Compostella

    Santiago de Compostela

Other trials in Spain

Switzerland2 sites

  • Kantonsspital Aarau

    Aarau

  • Hopital Cantonal de Fribourg

    Fribourg

Other trials in Switzerland

Greece1 site

  • Onassis cardiac Surgery Centre

    Athens

Other trials in Greece

About this study

Official title: Comparison of the Everolimus Eluting (XIENCE-V®, XIENCE-Prime® or PROMUS® Stent) With the Biolimus A9 Eluting NOBORI® Stent in All-comers: a Randomized Open Label Study

This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.

Read the detailed description

The main objective of the study is a head to head comparison of the everolimus eluting XIENCE-V ®, XIENCE-Prime® or PROMUS ® stent with the biolimus A9 eluting NOBORI® stent in order to observe whether there is a difference in clinical outcome between both stents in a real world / all-comer situation.

Clinical outcome of both stents will be assessed by the composite end point of: cardiac death, non fatal myocardial infarction and target vessel revascularization.

Endpoints

The primary end point of the study is the composite of safety (cardiac death, non fatal myocardial infarction) and efficacy (target vessel revascularization) at 12 months.

The secondary end points of the study are:

  1. The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 12 months follow-up.
  2. Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years C) Target lesion revascularization at 12 months, 3 and 5 years D) The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up.
  3. The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels (< 2.75 mm RVD), long lesions (> 20 mm), female patients, DM patients and octogenarians. F) Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.
  4. Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time.
  5. Incidence of definite, probable and possible stent thrombosis at 12 months, 3 and5 years time.

Overview of the study

This is a prospective, randomized, multi center study. Approximately 2700 patients will be entered in the study and will be randomized on a 2:1 basis. Patients who meet the eligibility criteria will be randomized to the everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent versus the Biolimus A9 eluting NOBORI® stent. Patients will be followed for 5 years.

The study population will consist of approximately 2700 patients (1 year enrollment of consecutive all-comers referred for percutaneous coronary intervention (PCI) with coronary artery or by-pass grafts lesions). Patients must meet all eligibility criteria for inclusion into the study.

Randomization will be performed by using a closed envelope with code N for the NOBORI stent and code E for the Everolimus eluting stent. Duration of the study The enrollment phase will start January 2009 and will stop December 2010. The followup phase will last till December 2015.

Being tested
the everolimus eluting ® stent, the Biolimus A9 eluting NOBORI® stent
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • the everolimus eluting ® stentDevice

    stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent

  • the Biolimus A9 eluting NOBORI® stentDevice

    stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent

Study groups in NCT01233453
Study groupRoleWhat they receive
the everolimus eluting ® stentActive comparatorthe everolimus eluting XIENCE-V®, XIENCE-Prime® or PROMUS® stent
Receives: Device: the everolimus eluting ® stent
Biolimus A9 stentActive comparatorthe Biolimus A9 eluting NOBORI® stent
Receives: Device: the Biolimus A9 eluting NOBORI® stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major adverse coronary events

    composite of cardiac death, non fatal myocardial infarction and target vessel revascularization

    Measured: 12 months

Secondary outcomes (7)

  1. Major adverse coronary events

    The combined endpoint of cardiac death, non fatal myocardial infarction, ischemic driven target lesion revascularization (TLR) rate at 12 months follow-up.

    Measured: 12 months

  2. Safety of stenting with drug eluting stents

    Incidence of Cardiac Death and Post-Procedural (>48h) MI rate at 12 months, 3 and 5 years

    Measured: 5 years

  3. Target lesion revascularization

    Target lesion revascularization at 12 months, 3 and 5 years

    Measured: 5 years

  4. Late major adverse coronary events

    The combined endpoint of cardiac death, non fatal myocardial infarction, target vessel revascularization (TVR) rate at 3 and 5 years follow-up.

    Measured: 5 years

  5. Major adverse coronary events in subgroups

    The combined endpoint of cardiac death, non fatal myocardial infarction and target vessel revascularization at 12 months, 3 and 5 years in STEMI patients, small vessels (< 2.75 mm RVD), long lesions (> 20 mm), female patients, DM patients and octogenarians

    Measured: 5 years

  6. Procedural performance

    Procedural performance at the index procedures, measured by the ability to cross the lesions with the designated DES stent.

    Measured: 1 year

  7. Stent Thrombosis

    Incidence of definite and probable stent thrombosis at 12 months, 3 and 5 years time.

    Incidence of definite, probable or possible stent thrombosis at 12 months, 3 and 5 years time

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2012
  4. Study completionDec 2015 (estimated)

Resources

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
None (open label)
Enrolment
2,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01233453
Sponsor's protocol ID
NL25754.101.08
Acronym
COMPARE-II
Status last verified
Jan 2014
First submitted
28 Oct 2010
Last updated
30 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Vlachojannis GJ, Smits PC, Hofma SH, Togni M, Vazquez N, Valdes M, Voudris V, Puricel S, Slagboom T, Goy JJ, den Heijer P, van der Ent M. Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer everolimus-eluting stents in patients with coronary artery disease: three-year follow-up of the COMPARE II (Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent) trial. EuroIntervention. 2015 Jul;11(3):272-9. doi: 10.4244/EIJV11I3A53.

    PubMed 26196753

  • Smits PC, Hofma S, Togni M, Vazquez N, Valdes M, Voudris V, Slagboom T, Goy JJ, Vuillomenet A, Serra A, Nouche RT, den Heijer P, van der Ent M. Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial. Lancet. 2013 Feb 23;381(9867):651-60. doi: 10.1016/S0140-6736(12)61852-2. Epub 2013 Jan 30.

    PubMed 23374650

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing the everolimus eluting ® stent and the Biolimus A9 eluting NOBORI® stent in people with Coronary Artery Disease, run by Maasstad Hospital at 11 sites in 4 countries.

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 5 inclusion and 7 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 30 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Netherlands, Spain, Switzerland, Greece. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major adverse coronary events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01233453, which also lists 2 linked publications.

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 30 Jan 2014.

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