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Myocardial InfarctionEXAMINAT10NNCT04462315

10-Years Follow-up of the EXAMINATION Trial

An observational study of Myocardial Infarction and ST Elevation Myocardial Infarction, run by Hospital Clinic of Barcelona 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

The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. Read more about this study

Who is it for?
Ages 18 years and older
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
How many people
1,498 participants
Where
11 sitesin 3 countries
Study dates
1 May 2015to 31 May 2020
Phase
Observational
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

Study population: The EXAMINATION trial population was an all-comers population with ST-elevation myocardial infarction, representative of routine clinical practice.

Who may be able to join

  • Patients who were enrolled in the EXAMINATION trial (NCT00828087).

Who cannot join

  • None.

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Spain8 sites

  • Complejo Hospitalario U. A Coruña

    A Coruña, Galicia, 15006

  • Hospital General de Alicante

    Alicante, Valencia, 03010

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025

  • Hospital Clínic i Provincial de Barcelona

    Barcelona, Catalonia, 08036

  • Hospital de Bellvitge

    Barcelona, Catalonia, 08907

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Son Dureta

    Palma de Mallorca, Mallorca, 07014

  • Hospital Álvaro Cunqueiro

    Vigo, Galicia, 36214

Other trials in Spain

Italy2 sites

  • Azienda Ospedaliero Universitaria S. Anna di Ferrara

    Ferrara, 44100

  • Azienda Ospedaliera Bolognini

    Seriate, Bergamo, 24068

Other trials in Italy

Netherlands1 site

  • Erasmus MC, Rotterdam

    Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: Ten-year Follow-up of the Clinical Evaluation of Everolimus-Eluting Coronary Stents in the Treatment of Patients With ST-segment Elevation Myocardial Infarction: EXAMINATION-EXTEND Trial

The EXAMINATION trial was a superiority trial that compared everolimus-eluting stents (EES) versus bare-metal stents (BMS) in an all-comer ST-segment elevation myocardial infarction (STEMI) population. The patient-oriented endpoint was not superior at 1-year, but it was at 5-year. However, very-long term follow-up is unknown. The study had an independent Clinical event Committee (CEC). All events were adjudicated by an independent clinical committee, according to the Academic Research Consortium 1.

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, ST Elevation Myocardial Infarction, Infarction, Necrosis, Heart Diseases, Cardiovascular Diseases, Vascular Diseases

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 NCT04462315
Study groupRoleWhat they receive
Everolimus ArmEverolimus Eluting Coronary Stent System
Receives: Drug: Everolimus Eluting Coronary Stent System
Non-drug eluting stent ArmCobalt 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. Patient-oriented Composite Endpoint (PoCE)

    Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.

    Measured: 10 years

Secondary outcomes (5)

  1. Device-oriented Composite Endpoint (DoCE)

    Rate of composite endpoint of cardiac death, Target vessel myocardial infarction, and Target lesion revascularization. Defined according to the Academic Research Consortium 1.

    Measured: 10 years

  2. Rate of all cause and cardiac mortality

    Defined according to the Academic Research Consortium 1.

    Measured: 10 years

  3. Rate of recurrent myocardial infarction

    Defined according to the Academic Research Consortium 1.

    Measured: 10 years

  4. Rate of target lesion revascularization

    Defined according to the Academic Research Consortium 1.

    Measured: 10 years

  5. Rate of stent thrombosis

    Defined according to the Academic Research Consortium 1.

    Measured: 10 years

Timeline

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

  1. First posted8 Jul 2020
  2. Study start1 May 2015
  3. Primary completion31 May 2020
  4. Study completion31 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,498 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04462315
Sponsor's protocol ID
HCB/2018/0906
Acronym
EXAMINAT10N
Status last verified
Jul 2020
First submitted
2 Jul 2020
Last updated
1 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Will be made available upon request.

Publications

  • 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

  • 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, 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

  • Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

    PubMed 17470709

  • Verardi FM, Bujak K, Tolomeo P, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Bordes P, Campo G, Silvestro A, Maristany J, Flores X, de Miguel-Castro A, Iniguez A, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Tebaldi M, Biscaglia S, Vidal-Cales P, Ortega-Paz L, Romaguera R, Gomez-Hospital JA, Serruys PW, Sabate M, Brugaletta S. Ten-year prognostic impact of target versus non-target vessel failure after STEMI. Insight from the EXAMINATION-EXTEND trial. Rev Esp Cardiol (Engl Ed). 2024 Mar;77(3):215-225. doi: 10.1016/j.rec.2023.07.001. Epub 2023 Jul 26. English, Spanish.

    PubMed 37506972

  • Spione F, Arevalos V, Gabani R, Ortega-Paz L, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Pineda J, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, Bastos-Fernandez G, Iniguez A, Serra A, Escaned J, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Al-Shaibani S, Romaguera R, Gomez-Hospital JA, Rodes-Cabau J, Serruys PW, Sabate M, Brugaletta S. Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial. J Am Heart Assoc. 2022 Dec 6;11(23):e025885. doi: 10.1161/JAHA.122.025885. Epub 2022 Nov 29.

    PubMed 36444863

  • Gabani R, Spione F, Arevalos V, Grima Sopesens N, Ortega-Paz L, Gomez-Lara J, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Pineda J, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, Bastos-Fernandez G, Iniguez A, Serra A, Escaned J, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Al-Shaibani S, Romaguera R, Gomez-Hospital JA, Rodes-Cabau J, Serruys PW, Sabate M, Brugaletta S. Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial. JACC Cardiovasc Interv. 2022 Oct 10;15(19):1965-1973. doi: 10.1016/j.jcin.2022.07.038. Epub 2022 Aug 22.

    PubMed 36008267

  • Brugaletta S, Gomez-Lara J, Ortega-Paz L, Jimenez-Diaz V, Jimenez M, Jimenez-Quevedo P, Diletti R, Mainar V, Campo G, Silvestro A, Maristany J, Flores X, Oyarzabal L, De Miguel-Castro A, Iniguez A, Serra A, Nombela-Franco L, Ielasi A, Tespili M, Lenzen M, Gonzalo N, Bordes P, Tebaldi M, Biscaglia S, Rodriguez-Arias JJ, Al-Shaibani S, Arevalos V, Romaguera R, Gomez-Hospital JA, Serruys PW, Sabate M. 10-Year Follow-Up of Patients With Everolimus-Eluting Versus Bare-Metal Stents After ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2021 Mar 9;77(9):1165-1178. doi: 10.1016/j.jacc.2020.12.059.

    PubMed 33663733

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction and ST Elevation Myocardial Infarction, run by Hospital Clinic of Barcelona 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 1 inclusion and 1 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 1 Sep 2022. 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?

Patient-oriented Composite Endpoint (PoCE) (time frame: 10 years). 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 NCT04462315, which also lists 8 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 1 Sep 2022.

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