10-Years Follow-up of the EXAMINATION Trial (EXAMINAT10N)

August 29, 2022 updated by: Hospital Clinic of Barcelona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Ferrara, Italy, 44100
        • Azienda Ospedaliero Universitaria S. Anna di Ferrara
    • Bergamo
      • Seriate, Bergamo, Italy, 24068
        • Azienda Ospedaliera Bolognini
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC, Rotterdam
  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
    • Cataluña
      • Barcelona, Cataluña, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Cataluña, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Cataluña, Spain, 08907
        • Hospital de Bellvitge
    • Galicia
      • A Coruña, Galicia, Spain, 15006
        • Complejo Hospitalario U. A Coruña
      • Vigo, Galicia, Spain, 36214
        • Hospital Álvaro Cunqueiro
    • Mallorca
      • Palma De Mallorca, Mallorca, Spain, 07014
        • Hospital Son Dureta
    • Valencia
      • Alicante, Valencia, Spain, 03010
        • Hospital General de Alicante

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Everolimus Arm
Everolimus Eluting Coronary Stent System
Drug: Everolimus Eluting Coronary Stent System
Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
Other Names:
  • N/H
Non-drug eluting stent Arm
Cobalt chromium balloon-expandable stent
Device: Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)
Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation
Other Names:
  • N/H

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented Composite Endpoint (PoCE)
Time Frame: 10 years
Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-oriented Composite Endpoint (DoCE)
Time Frame: 10 years
Rate of composite endpoint of cardiac death, Target vessel myocardial infarction, and Target lesion revascularization. Defined according to the Academic Research Consortium 1.
10 years
Rate of all cause and cardiac mortality
Time Frame: 10 years
Defined according to the Academic Research Consortium 1.
10 years
Rate of recurrent myocardial infarction
Time Frame: 10 years
Defined according to the Academic Research Consortium 1.
10 years
Rate of target lesion revascularization
Time Frame: 10 years
Defined according to the Academic Research Consortium 1.
10 years
Rate of stent thrombosis
Time Frame: 10 years
Defined according to the Academic Research Consortium 1.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Study Chair: Manel Sabaté, MD, PhD, Hospital Clinic of Barcelona
  • Principal Investigator: Salvatore Brugaletta, MD, PhD, Hospital Clinic of Barcelona
  • Principal Investigator: Josep Gómez-Lara, MD, PhD, Hospital Universitari de Bellvitge
  • Principal Investigator: Luis Ortega-Paz, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 8, 2020

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCB/2018/0906

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Will be made available upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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