ACSEPICORNCT01171404

Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge

An observational study of ACS and Acute Coronary Syndrome, run by AstraZeneca at 410 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: ACS, Acute Coronary Syndrome, Myocardial Infarction
How many people: 10,568 participants
Where: 410 sitesin 20 countries
Study dates: Sep 2010to Mar 2013
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: Patients hospitalized within 24 hours of onset of symptoms and diagnosed with unstable angina (UA), STEMI or non-STEMI(NSTEMI). Patients will be invited to participate by the hospital (Academic or Community) which is going to discharge the patient. Participating investigators will belong to hospitals (Academic, Community, with/without cathlab, etc), in the proportion representing the reality of where this kind of patients are managed in each country.

Who may be able to join

Diagnosis of myocardial infarction or unstable angina
Hospitalized for the first time within 24 hours of onset of symptoms

Who cannot join

Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances)
Current participation in a clinical trial.

Trial locations and contacts

410 sites in 20 countries.

Country

City, postcode or hospital

410 sites in 20 countries

Spain41 sites

Research Site
Alcalá de Henares
Research Site
Alcoy
Research Site
Alicante
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Aranjuez
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Ávila
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Barcelona
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Baza
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Ciudad Real
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Coslada
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Elche
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Elda
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Ferrol
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Fuenlabrada
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Gandia
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Girona
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Huelva
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Huercal Overa
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Huesca
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Igualada
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León
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Lugo
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Madrid
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Palencia
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Pozoblanco
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Puertollano
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Salamanca
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San Juan
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San Sebastián de los Reyes
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Santiago de Compostela
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Segovia
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Seville
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Tarragona
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Terrassa
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Toledo
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Torrevieja
Research Site
Tortosa
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Valencia
Research Site
Vélez-Málaga
Research Site
Vic
Research Site
Villajoyosa
Research Site
Zaragoza

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France39 sites

Research Site
Antony
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Argenteuil
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Avignon
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Belfort
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Boulogne-Billancourt
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Bourges
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Brest
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Brive-la-Gaillarde
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Caen
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Chambéry
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Chambray-lès-Tours
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Colmar
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Dijon
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Dunkirk
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Haguenau
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Hopital Civil (strasbourg Cedex)
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La Rochelle
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La Source
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Lagny-sur-Marne
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Le Chesnay
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Le Coudray
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Le Plessis-Robinson
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Marignane
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Marseille
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Metz
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Montfermeil
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Montreuil
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Mulhouse
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Nice
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Paris
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Perpignan
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Quimper
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Reims
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Saint-Brieuc
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Saint-Michel-sur-Orge
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Strasbourg
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Suresnes
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Valence
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Vandœuvre-lès-Nancy

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Belgium32 sites

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(Jette) Bruxelles
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Aalst
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Antwerp
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Brasschaat
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Bruges
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Brussels
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Charleroi
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Chênée
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Dendermonde
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Edegem
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Eeklo
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Genk
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La Louvière
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Leuven
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Lier
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Merksem
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Mol
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Mons
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Montigny-le-Tilleul
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Namur
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Ostend
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Ottignies
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Overpelt
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Roeselare
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Ronse
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Seraing
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Sint-Niklaas
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Soignies
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Tienen
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Tournai
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Turnhout
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Veurne

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Germany29 sites

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Berlin
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Bielefeld
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Bochum
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Bonn
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Borken
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Cloppenburg
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Coburg
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Detmold
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Dortmund
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Essen
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Esslingen am Neckar
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Greifswald
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Hanover
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Heidelberg
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Herrsching am Ammersee
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Landshut
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Leverkusen
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Lübeck
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Ludwigshafen
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Mainz
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Merseburg
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Mönchengladbach
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Mühlheim
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Olsberg
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Regensburg
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Rostock
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Stuttgart
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Suhl
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Warendorf

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Romania29 sites

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Alba Iulia
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Arad
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Bacau
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Baia Mare
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Bistriţa
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Brăila
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Brasov
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Bucharest
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Buzău
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Cluj-Napoca
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Constanța
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Craiova
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Drobeta-Turnu Severin
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Focşani
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Galati
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Hunedoara
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Iași
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Oradea
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Piatra Neamţ
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Piteşti
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Ploieşti
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Râmnicu Vâlcea
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Sibiu
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Slatina
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Suceava
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Targoviste
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Târgu Mureş
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Timișoara
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Zalău

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United Kingdom29 sites

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Airdrie
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Antrim
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Basingstoke
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Belfast
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Birmingham
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Blackburn
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Blackpool
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Craigavon
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Croydon
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East Kilbride
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Essex
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Glasgow
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Harrow
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Hastings
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Hertfordshire
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High Wycombe
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Kirkcaldy
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Livingston
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London
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Manchester
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Middlesbrough
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Morriston Hospital (Swansea)
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Newcastle upon Tyne
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Peterborough
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Rotherham
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Sheffield
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Stevenage
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Sutton Coldfield
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Worcester

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Mexico25 sites

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Cardenas, Tabasco
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Chihuahua City
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Chihuahua, Chihuahua
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Durango
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Durango, Durango
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Guadalajara
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Guadalajara, Jalisco
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Guanajuato City
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León
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Merida, Yucatan
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Mexicali, Baja California
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Mexico City
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Monterrey, Nuevo Leon
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Oaxaca, Oaxaca
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Puebla, Puebla
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Querétaro
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Saltillo Coahuila
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San Luis Potosí City
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Sinaloa, Culiacan
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Tabasco
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Tijuana B.C.
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Toluca, Estado de Mexico
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Torreón
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Torreon Coahuila
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Xalapa, Veracruz

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Norway25 sites

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Bergen
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Bodø
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Elverum
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Flekkefjord
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Førde
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Gjøvik
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Hamar
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Hammerfest
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Harstad
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Haugesund
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Hønefoss
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Kongsvinger
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Kristiansund N
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Levanger
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Lillehammer
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Lorenskog
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Molde
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Oslo
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Rjukan
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Rud
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Skien
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Tønsberg
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Tromsø
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Trondheim
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Tynset

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Italy24 sites

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Ancona
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Catanzaro
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Ferrara
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Florence
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Genova
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Massa
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Milan
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Naples
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Napoli Caserta
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Nuoro
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Pescara
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Rho
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Rimini
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Roma
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Rovigo
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Sassari
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Treviso
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Udine
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Varese
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Versilia

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Poland22 sites

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Bydgoszcz
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Elblag
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Jelenia Góra
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Kalisz
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Koszalin
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Krakow
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Oława
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Olsztyn
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Opole
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Ostrow Maz.
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Poznan
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Pruszków
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Radom
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Sandomierz
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Słupsk
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Tarnów
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Torun
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Wałbrzych
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Warsaw
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Wroclaw

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Turkey (Türkiye)19 sites

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Adana
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Ankara
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Antalya
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Çanakkale
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Diyarbak?r
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Elaz?g
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Erzurum
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Eskişehir
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Gaziantep
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Istanbul
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Izmir
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Kayseri
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Konya
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Malatya
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Manisa
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Mersin
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Samsun
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Sivas
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Trabzon

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Netherlands18 sites

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Amstelveen
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Amsterdam
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Beverwijk
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Delft
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Den Bosh
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Doetinchem
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Goes
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Haarlem
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Heerlen
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Hoofddorp
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Hoogeveen
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Purmerend
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Argentina16 sites

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Corrientes
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Mar del Plata
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Mendoza
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Monteros
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Quilmes
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Rosario
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Salta
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San Isidro
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Denmark16 sites

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Aalborg
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Aarhus
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Arhus N
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Esbjerg
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Fredericia
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Frederiksberg
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Haderslev
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Hellerup
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Herning
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Hjørring
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Hvidovre
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København NV
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Odense C
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Brazil15 sites

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Marília
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Greece12 sites

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Finland9 sites

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Tampere
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Venezuela7 sites

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Slovenia2 sites

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Luxembourg1 site

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About this study

Official title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions.

Conditions: ACS, Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina, Coronary Artery Disease
Keywords: Acute coronary syndrome, heart attack, myocardial infarction, ACS long-tem follow up, antithrombotic management, quality of life, Antithrombotic
Medical subject headings: Acute Coronary Syndrome, Myocardial Infarction, Angina, Unstable, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01171404
Study group	Role	What they receive
1		Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes
Measured: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)

Secondary outcomes (3)

Antithrombotic treatments
Measured: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Use of health care resources
Measured: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Quality of life
Measured: At index event (baseline) and then at 6 weeks and each 3 months after index event

Timeline

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

Sep 2010Mar 2013

First posted28 Jul 2010 (estimated)
Study startSep 2010
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for ACSStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 10,568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01171404
Sponsor's protocol ID: NIS-CEU-DUM-2009/1
Acronym: EPICOR
Status last verified: Apr 2013
First submitted: 27 Jul 2010
Last updated: 17 Apr 2013
Results posted: No
Data monitoring committee: No

Publications

Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.
PubMed 33537947
Martin-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.
PubMed 33420682
Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.
PubMed 30588886
Bardaji A, Leal M, Arrarte V, Garcia-Moll X, Perez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.
PubMed 27885830
Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.
PubMed 27504002
Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.
PubMed 27127635
Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.
PubMed 26853249
Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.
PubMed 25374386
Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.
PubMed 25301783
Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.
PubMed 23237128

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Spontaneous Coronary Artery Dissection - AntipLatelet Therapy Intensity in Guided coNservative Management (SCAD-ALIGN) Trial
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Coronary Arterial Disease (CAD), Vulnerable Coronary Plaques

All ACS trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients
ClinicalTrials.gov ID: NCT01171404
Acronym / sponsor ID: EPICOR / NIS-CEU-DUM-2009/1
Conditions: ACS, Acute Coronary Syndrome, Myocardial Infarction, Unstable Angina, Coronary Artery Disease
Keywords: Acute coronary syndrome, heart attack, myocardial infarction, ACS long-tem follow up, antithrombotic management, quality of life, Antithrombotic
Study type: Observational
Recruitment status: Completed
Enrolment: 10,568 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 28 Jul 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	–Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients hospitalized within 24 hours of onset of symptoms and diagnosed with unstable angina (UA), STEMI or non-STEMI(NSTEMI). Patients will be invited to participate by the hospital (Academic or Community) which is going to discharge the patient. Participating investigators will belong to hospitals (Academic, Community, with/without cathlab, etc), in the proportion representing the reality of where this kind of patients are managed in each country.

Key inclusion criteria (2 listed)

Diagnosis of myocardial infarction or unstable angina
Hospitalized for the first time within 24 hours of onset of symptoms

Key exclusion criteria (2 listed)

Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, psychiatric disturbances)
Current participation in a clinical trial.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes
Time frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)

3 secondary outcomes

Antithrombotic treatments
Time frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Use of health care resources
Time frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Quality of life
Time frame: At index event (baseline) and then at 6 weeks and each 3 months after index event

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
Derived from this study: PubMed 33537947Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.
Derived from this study: PubMed 33420682Martin-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.
Derived from this study: PubMed 30588886Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.
Derived from this study: PubMed 27885830Bardaji A, Leal M, Arrarte V, Garcia-Moll X, Perez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.
Derived from this study: PubMed 27504002Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.
Derived from this study: PubMed 27127635Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.
Derived from this study: PubMed 26853249Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.
Derived from this study: PubMed 25374386Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.
Derived from this study: PubMed 25301783Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.
Derived from this study: PubMed 23237128Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mónica Tafalla study director

Medical Department.AstraZeneca Spain

410 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of ACS and Acute Coronary Syndrome, run by AstraZeneca at 410 sites in 20 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 2 inclusion and 2 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 17 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 410 sites in Spain, France, Belgium, Germany, Romania and 15 more countries. 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?

Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes (time frame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)). 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 NCT01171404, which also lists 10 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 17 Apr 2013.