Cardiovascular Diseases Clinical Trial
— EXAMINAT10NOfficial 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
NCT number | NCT04462315 |
Other study ID # | HCB/2018/0906 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2015 |
Est. completion date | May 31, 2020 |
Verified date | July 2020 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1498 |
Est. completion date | May 31, 2020 |
Est. primary completion date | May 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who were enrolled in the EXAMINATION trial (NCT00828087). Exclusion Criteria: - None. |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero Universitaria S. Anna di Ferrara | Ferrara | |
Italy | Azienda Ospedaliera Bolognini | Seriate | Bergamo |
Netherlands | Erasmus MC, Rotterdam | Rotterdam | |
Spain | Complejo Hospitalario U. A Coruña | A Coruña | Galicia |
Spain | Hospital General de Alicante | Alicante | Valencia |
Spain | Hospital Clínic i Provincial de Barcelona | Barcelona | Cataluña |
Spain | Hospital de Bellvitge | Barcelona | Cataluña |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | Cataluña |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital Son Dureta | Palma De Mallorca | Mallorca |
Spain | Hospital Álvaro Cunqueiro | Vigo | Galicia |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Italy, Netherlands, Spain,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 10 years | |
Secondary | 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. | 10 years | |
Secondary | Rate of all cause and cardiac mortality | Defined according to the Academic Research Consortium 1. | 10 years | |
Secondary | Rate of recurrent myocardial infarction | Defined according to the Academic Research Consortium 1. | 10 years | |
Secondary | Rate of target lesion revascularization | Defined according to the Academic Research Consortium 1. | 10 years | |
Secondary | Rate of stent thrombosis | Defined according to the Academic Research Consortium 1. | 10 years |
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