NCT00828087

Brief 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. 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,504

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
3 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 23, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

6.4 years

First QC Date

January 22, 2009

Last Update Submit

May 18, 2015

Conditions

Myocardial Infarction

Keywords

acute myocardial infarctionprimary percutaneous coronary interventiondrug-eluting stent

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (8)

  • 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

    at 1 year and yearly up to 5 years

  • +3 more secondary outcomes

Study Arms (2)

Everolimus Arm

EXPERIMENTAL

Everolimus Eluting Coronary Stent System

Drug: Everolimus Eluting Coronary Stent System

non drug eluting stent Arm

ACTIVE COMPARATOR

cobalt chromium balloon expandable stent

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

Interventions

Everolimus Eluting Coronary Stent SystemDRUG

Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation

Also known as: N/H
Everolimus Arm
cobalt chromium balloon expandable stent ( non drug eluting stent Arm)DEVICE

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

Also known as: N/H.
non drug eluting stent Arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Azienda Ospedaliera Bolognini

Seriate, Bergamo, 24068, Italy

Location

Azienda Ospedaliero Universitaria S. Anna di Ferrara

Ferrara, Italy, 44100, Italy

Location

Erasmus MC, Rotterdam

Rotterdam, Rotterdam, 3015 GD, Netherlands

Location

Complejo Hospitalario U. A Coruña

A Coruña, A Croruña, 15006, Spain

Location

Hospital General de Alicante

Alicante, Alicante, 03010, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Balearic Islands, 07014, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital de Bellvitge

Barcelona, Barcelona, 08907, Spain

Location

Hospital Clínico San Carlos

Madrid, Madrid, 28040, Spain

Location

Hospital do Meixoeiro

Vigo, Vigo, 36214, Spain

Location

Related Publications (9)

  • 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.

    PMID: 31451013DERIVED

  • 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.

    PMID: 30114230DERIVED

  • 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.

    PMID: 27702766DERIVED

  • 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.

    PMID: 26520230DERIVED

  • 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.

    PMID: 25042419DERIVED

  • 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.

    PMID: 24867891DERIVED

  • 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.

    PMID: 24332423DERIVED

  • 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.

    PMID: 22951305DERIVED

  • 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.

    PMID: 22115622DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Prof. P.W. Serruys, MD,PhD

    Erasmus MC, Rotterdam

    PRINCIPAL INVESTIGATOR

  • Manuel Sabate, MD,PhD

    Hospital Clínic i Provincial de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 23, 2009

Study Start

December 1, 2008

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

IT(2)NL(1)ES(8)