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Myocardial InfarctionNCT00828087

A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION Study

A study testing Everolimus Eluting Coronary Stent System and cobalt chromium balloon expandable stent ( non drug eluting stent Arm) in people with Myocardial Infarction, run by Spanish Society of Cardiology at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study. Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. Read more about this study

Who is it for?
Any age
Conditions the study is for
Myocardial Infarction
What is being tested?
Everolimus Eluting Coronary Stent System and cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,504 participants
Where
11 sitesin 3 countries
Study dates
Dec 2008to May 2015
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients presenting with a ST-elevation myocardial infarction who must meet at least one of the following criteria
  • Patients presenting with a ST-elevation myocardial infarction <12 hours after onset of symptoms who are treated with primary angioplasty + stent implantation
  • Cardiogenic shock.
  • Rescue PCI after failed thrombolysis.
  • PCI indicated early (<24h) after effective thrombolysis following current ESC guidelines.
  • Patients presenting late ("latecomers") with ST-elevation myocardial infarction (>12h-48h) after the onset of symptoms.
Show all 10Show fewer
  • Written informed consent.
  • The patient or his/her family (in the event the patient can not be clinically available) accept clinical controls.
  • Angiographic:
  • Vessel size has to range between 2.25-4.0 mm by visual estimation to allow the implantation of currently available stents.

Who cannot join

  • Age < 18 years.
  • Pregnancy or breastfeeding.
  • Known intolerance to aspirin, clopidogrel, heparin, stainless steel, Everolimus, contrast material.
  • Patients with absolute indication of being chronic treated with acenocoumarol
  • Myocardial infarction due to a previously implanted stent thrombosis
  • Patients with myocardial infarction that will require elective surgical coronary revascularisation within a 1 year period (example: inferior MI with severe disease in left main with surgical indication).

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Spain8 sites

  • Complejo Hospitalario U. A Coruña

    A Coruña, A Croruña, 15006

  • Hospital General de Alicante

    Alicante, Alicante, 03010

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital de Bellvitge

    Barcelona, Barcelona, 08907

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital Son Dureta

    Palma de Mallorca, Balearic Islands, 07014

  • Hospital do Meixoeiro

    Vigo, Vigo, 36214

Other trials in Spain

Italy2 sites

  • Azienda Ospedaliero Universitaria S. Anna di Ferrara

    Ferrara, Italy, 44100

  • Azienda Ospedaliera Bolognini

    Seriate, Bergamo, 24068

Other trials in Italy

Netherlands1 site

  • Erasmus MC, Rotterdam

    Rotterdam, Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction.EXAMINATION Study

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

Read the detailed description

Primary PCI, with or without stenting, has been shown to result in superior long-term outcome when compared to thrombolytic therapy in patients with acute myocardial infarction (MI).

Recently, several studies showed that both sirolimus- and paclitaxel-eluting stents are more effective in reducing restenosis and the frequency of repeat interventions than bare metal stents, which rapidly resulted in an unrestricted use of drug-eluting stents, also in patients with ST segment elevation MI (STEMI). , , , Shortly after the introduction of the sirolimus-eluting stent in April 2002 the first studies appeared, hypothesizing that the therapeutic range of sirolimus-eluting stents could be extended to patients presenting with MI. When compared to bare metal stents, sirolimus-eluting stents were associated with less restenosis and target vessel revascularization (TVR) up until one year of follow-up. , At present, it is unclear whether this also holds for paclitaxel-eluting stents.4,

Everolimus is a sirolimus analogue, an effective anti-proliferative agent that inhibits growth factor-stimulated cell proliferation by causing cell cycle arrest in the late G1 stage in the cell cycle.

The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction.

This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.

The primary endpoint is the combined endpoint of Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year (patient oriented endpoint suggested by the ARC definitions).

The following secondary endpoints will be examined:

  • All cause and cardiac mortality at 1 year and yearly up to 5 years.
  • Recurrent myocardial infarction at 1 year and yearly up to 5 years.
  • Target lesion revascularization at 1 year and yearly up to 5 years.
  • Target vessel revascularization at 1 year and yearly up to 5 years.
  • Stent thrombosis (according to the new definitions proposed by the Academic Research Consortium) at 1 year and yearly up to 5 years.
  • Clinical device success
  • Clinical procedure success.
  • Major and minor bleeding at 1 year and yearly up to 5 years.
Being tested
Everolimus Eluting Coronary Stent System, cobalt chromium balloon expandable stent ( non drug eluting stent Arm)
Keywords
acute myocardial infarction, primary percutaneous coronary intervention, drug-eluting stent
Medical subject headings
Myocardial Infarction

What participants receive

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

  • Everolimus Eluting Coronary Stent SystemDrug

    Also called N/H

    Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

  • cobalt chromium balloon expandable stent ( non drug eluting stent Arm)Device

    Also called N/H.

    cobalt chromium balloon expandable stent ( non drug eluting stent Arm)implantation

Study groups in NCT00828087
Study groupRoleWhat they receive
Everolimus ArmExperimentalEverolimus Eluting Coronary Stent System
Receives: Drug: Everolimus Eluting Coronary Stent System
non drug eluting stent ArmActive comparatorcobalt chromium balloon expandable stent
Receives: Device: cobalt chromium balloon expandable stent ( non drug eluting stent Arm)

What is being measured

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

  1. Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year.

    Measured: 1 year

Secondary outcomes (8)

  1. All cause and cardiac mortality

    Measured: at 1 year and yearly up to 5 years

  2. Recurrent myocardial infarction

    Measured: at 1 year and yearly up to 5 years

  3. Target lesion revascularization

    Measured: at 1 year and yearly up to 5 years

  4. Target vessel revascularization

    Measured: at 1 year and yearly up to 5 years

  5. Stent thrombosis

    Measured: at 1 year and yearly up to 5 years

  6. Clinical device success

    Successful delivery and deployment of the first inserted stent and a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment.

    Measured: Procedure moment

  7. Clinical procedure success

    Successful delivery and deployment of study stent in the target lesion and successful removal of the stent delivery system with a final diameter stenosis after stenting ≤ 50% by QCA or visual assessment without the occurrence of serious cardiac events important for ischemia during hospitalization, with a maximum of seven days after the initial procedure.

    Measured: procedure moment

  8. Major and minor bleeding

    Measured: at 1 year and yearly up to 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 posted23 Jan 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionMay 2015
  4. Study completionMay 2015

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
1,504 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00828087
Sponsor's protocol ID
EXAM-08
Status last verified
May 2015
First submitted
22 Jan 2009
Last updated
19 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Costa F, Brugaletta S, Pernigotti A, Flores-Ulmanzor E, Ortega-Paz L, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys P, Sabate M. Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention? Circ Cardiovasc Interv. 2019 Sep;12(9):e007705. doi: 10.1161/CIRCINTERVENTIONS.118.007705. Epub 2019 Aug 27.

    PubMed 31451013

  • Schur N, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Valgimigli M, Serruys PW, Ademi Z, Schwenkglenks M, Sabate M. Cost-effectiveness of everolimus-eluting versus bare-metal stents in ST-segment elevation myocardial infarction: An analysis from the EXAMINATION randomized controlled trial. PLoS One. 2018 Aug 16;13(8):e0201985. doi: 10.1371/journal.pone.0201985. eCollection 2018.

    PubMed 30114230

  • Gomez-Lara J, Brugaletta S, Jacobi F, Ortega-Paz L, Nato M, Roura G, Romaguera R, Ferreiro JL, Teruel L, Gracida M, Martin-Yuste V, Freixa X, Masotti M, Gomez-Hospital JA, Sabate M, Cequier A. Five-Year Optical Coherence Tomography in Patients With ST-Segment-Elevation Myocardial Infarction Treated With Bare-Metal Versus Everolimus-Eluting Stents. Circ Cardiovasc Interv. 2016 Oct;9(10):e003670. doi: 10.1161/CIRCINTERVENTIONS.116.003670.

    PubMed 27702766

  • Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Jimenez-Quevedo P, Mainar V, Campo G, Tespili M, den Heijer P, Bethencourt A, Vazquez N, van Es GA, Backx B, Valgimigli M, Serruys PW. Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial. Lancet. 2016 Jan 23;387(10016):357-366. doi: 10.1016/S0140-6736(15)00548-6. Epub 2015 Oct 29.

    PubMed 26520230

  • Taniwaki M, Stefanini GG, Raber L, Brugaletta S, Cequier A, Heg D, Iniguez A, Kelbaek H, Serra A, Ostoijic M, Hernandez-Antolin R, Baumbach A, Blochlinger S, Juni P, Mainar V, Sabate M, Windecker S. Predictors of adverse events among patients undergoing primary percutaneous coronary intervention: insights from a pooled analysis of the COMFORTABLE AMI and EXAMINATION trials. EuroIntervention. 2015 Aug;11(4):391-8. doi: 10.4244/EIJY14M07_12.

    PubMed 25042419

  • Fernandez-Rodriguez D, Regueiro A, Brugaletta S, Martin-Yuste V, Masotti M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Serruys PW, Sabate M; EXAMINATION investigators. Optimization in stent implantation by manual thrombus aspiration in ST-segment-elevation myocardial infarction: findings from the EXAMINATION trial. Circ Cardiovasc Interv. 2014 Jun;7(3):294-300. doi: 10.1161/CIRCINTERVENTIONS.113.000964. Epub 2014 May 27.

    PubMed 24867891

  • Sabate M, Brugaletta S, Cequier A, Iniguez A, Serra A, Hernadez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Backx B, Serruys PW. The EXAMINATION trial (Everolimus-Eluting Stents Versus Bare-Metal Stents in ST-Segment Elevation Myocardial Infarction): 2-year results from a multicenter randomized controlled trial. JACC Cardiovasc Interv. 2014 Jan;7(1):64-71. doi: 10.1016/j.jcin.2013.09.006. Epub 2013 Dec 11.

    PubMed 24332423

  • Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gomez-Hospital JA, Baz JA, Martin-Yuste V, van Geuns RJ, Alfonso F, Bordes P, Tebaldi M, Masotti M, Silvestro A, Backx B, Brugaletta S, van Es GA, Serruys PW. Everolimus-eluting stent versus bare-metal stent in ST-segment elevation myocardial infarction (EXAMINATION): 1 year results of a randomised controlled trial. Lancet. 2012 Oct 27;380(9852):1482-90. doi: 10.1016/S0140-6736(12)61223-9. Epub 2012 Sep 3.

    PubMed 22951305

  • Sabate M, Cequier A, Iniguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Brugaletta S, Backx B, Serruys P. Rationale and design of the EXAMINATION trial: a randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction. EuroIntervention. 2011 Dec;7(8):977-84. doi: 10.4244/EIJV7I8A154.

    PubMed 22115622

Questions about this trial

What is this clinical trial studying?

A study testing Everolimus Eluting Coronary Stent System and cobalt chromium balloon expandable stent ( non drug eluting stent Arm) in people with Myocardial Infarction, run by Spanish Society of Cardiology at 11 sites in 3 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 10 inclusion and 6 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: finished, as of the sponsor's last update on 19 May 2015. 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 Spain, Italy, Netherlands. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year. (time frame: 1 year). 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 NCT00828087, which also lists 9 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 19 May 2015.

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