EXAMINAT10N: 10-Years Follow-up of the EXAMINATION Trial
Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Completed
CT.gov ID
NCT04462315
Collaborator
(none)
1,498
11
61
136.2
2.2
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
1498 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date
:
May 1, 2015
Actual Primary Completion Date
:
May 31, 2020
Actual Study Completion Date
:
May 31, 2020
Arms and Interventions
| Arm | 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- Patient-oriented Composite Endpoint (PoCE) [10 years]
Rate of composite endpoint of all-cause death, any myocardial infarction, and any revascularization. Defined according to the Academic Research Consortium 1.
Secondary Outcome Measures
- Device-oriented Composite Endpoint (DoCE) [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.
- Rate of all cause and cardiac mortality [10 years]
Defined according to the Academic Research Consortium 1.
- Rate of recurrent myocardial infarction [10 years]
Defined according to the Academic Research Consortium 1.
- Rate of target lesion revascularization [10 years]
Defined according to the Academic Research Consortium 1.
- Rate of stent thrombosis [10 years]
Defined according to the Academic Research Consortium 1.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients who were enrolled in the EXAMINATION trial (NCT00828087).
Exclusion Criteria:
- None.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azienda Ospedaliera Bolognini | Seriate | Bergamo | Italy | 24068 |
| 2 | Azienda Ospedaliero Universitaria S. Anna di Ferrara | Ferrara | Italy | 44100 | |
| 3 | Erasmus MC, Rotterdam | Rotterdam | Netherlands | 3015 GD | |
| 4 | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluña | Spain | 08025 |
| 5 | Hospital Clínic i Provincial de Barcelona | Barcelona | Cataluña | Spain | 08036 |
| 6 | Hospital de Bellvitge | Barcelona | Cataluña | Spain | 08907 |
| 7 | Complejo Hospitalario U. A Coruña | A Coruña | Galicia | Spain | 15006 |
| 8 | Hospital Álvaro Cunqueiro | Vigo | Galicia | Spain | 36214 |
| 9 | Hospital Son Dureta | Palma De Mallorca | Mallorca | Spain | 07014 |
| 10 | Hospital General de Alicante | Alicante | Valencia | Spain | 03010 |
| 11 | Hospital Clínico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Hospital Clinic of Barcelona
Investigators
- 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
- Study Chair: Manel Sabaté, MD, PhD, Hospital Clinic of Barcelona
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Sabaté M, Brugaletta S, Cequier A, Iñiguez A, Serra A, Jiménez-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.
- Sabaté M, Cequier A, Iñiguez A, Serra A, Hernández-Antolín R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vázquez 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.
- Sabate M, Cequier A, Iñiguez A, Serra A, Hernandez-Antolin R, Mainar V, Valgimigli M, Tespili M, den Heijer P, Bethencourt A, Vazquez N, Gómez-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.
Responsible Party:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT04462315
Other Study ID Numbers:
- HCB/2018/0906
First Posted:
Jul 8, 2020
Last Update Posted:
Jul 9, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Clinic of Barcelona
Additional relevant MeSH terms: