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

Coronary Artery Disease Clinical Trial

— EPICOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171404
• Other study ID #: NIS-CEU-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: July 27, 2010
• Last updated: April 16, 2013
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardBrazil: National Committee of Ethics in ResearchBrazil: Ethics CommitteeDenmark: Danish Dataprotection AgencyFinland: Ethics CommitteeFinland: Ministry of Social Affairs and HealthFrance: Institutional Ethical CommitteeFrance: French Data Protection AuthorityGermany: Ethics CommissionGreece: Ethics CommitteeGreece: Ministry of Health and WelfareItaly: Ethics CommitteeMexico: Ethics CommitteeNetherlands: Independent Ethics CommitteeNorway:National Committee for Medical and Health Research EthicsPoland: Ethics CommitteePortugal: Ethics Committee for Clinical ResearchRomania: National Medicines AgencyRomania: Ministry of Public HealthSlovenia: Ethics CommitteeSpain: Ethics CommitteeSpain: Agencia Española de Medicamentos y Productos SanitariosTurkey: Ministry of HealthUnited Kingdom: Research Ethics CommitteeVenezuela: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10568
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of myocardial infarction or unstable angina

• Hospitalized for the first time within 24 hours of onset of symptoms

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ACS
• Acute Coronary Syndrome
• Angina, Unstable
• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Syndrome
• Unstable Angina

Locations

Country	Name	City	State
Argentina	Research Site	Avellaneda
Argentina	Research Site	Bahia Blanca
Argentina	Research Site	Ciudad Autonoma de Buenos Aires
Argentina	Research Site	Ciudadela
Argentina	Research Site	Cordoba
Argentina	Research Site	Corrientes
Argentina	Research Site	General Roca
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Monteros
Argentina	Research Site	Quilmes
Argentina	Research Site	Rosario
Argentina	Research Site	Salta
Argentina	Research Site	San Isidro
Argentina	Research Site	San Miguel de Tucuman
Argentina	Research Site	San Salvador de Jujuy
Belgium	Research Site	(Jette) Bruxelles
Belgium	Research Site	Aalst
Belgium	Research Site	Antwerpen
Belgium	Research Site	Brasschaat
Belgium	Research Site	Brugge
Belgium	Research Site	Brussel
Belgium	Research Site	Bruxelles
Belgium	Research Site	Charleroi
Belgium	Research Site	Chenee
Belgium	Research Site	Dendermonde
Belgium	Research Site	Edegem
Belgium	Research Site	Eeklo
Belgium	Research Site	Genk
Belgium	Research Site	La Louviere
Belgium	Research Site	Leuven
Belgium	Research Site	Lier
Belgium	Research Site	Merksem
Belgium	Research Site	Mol
Belgium	Research Site	Mons
Belgium	Research Site	Montigny-le-Tilleul
Belgium	Research Site	Namur
Belgium	Research Site	Oostende
Belgium	Research Site	Ottignies
Belgium	Research Site	Overpelt
Belgium	Research Site	Roeselare
Belgium	Research Site	Ronse
Belgium	Research Site	Seraing
Belgium	Research Site	Sint-Niklaas
Belgium	Research Site	Soignies
Belgium	Research Site	Tienen
Belgium	Research Site	Tournai
Belgium	Research Site	Turnhout
Belgium	Research Site	Veurne
Brazil	Research Site	Aracaju
Brazil	Research Site	Belo Horizonte
Brazil	Research Site	Blumenau
Brazil	Research Site	Brasilia
Brazil	Research Site	Campina Grande do Sul
Brazil	Research Site	Campo Grande
Brazil	Research Site	Curitiba
Brazil	Research Site	Marilia
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Jose do Rio Preto
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Tatu
Brazil	Research Site	Uberlandia
Brazil	Research Site	Votuporanga
Denmark	Research Site	Aalborg
Denmark	Research Site	Aarhus
Denmark	Research Site	Arhus N
Denmark	Research Site	Esbjerg
Denmark	Research Site	Fredericia
Denmark	Research Site	Frederiksberg
Denmark	Research Site	Haderslev
Denmark	Research Site	Hellerup
Denmark	Research Site	Herning
Denmark	Research Site	Hjorring
Denmark	Research Site	Hvidovre
Denmark	Research Site	Kobenhavn NV
Denmark	Research Site	Kobenhavn o
Denmark	Research Site	Odense C
Denmark	Research Site	Silkeborg
Denmark	Research Site	Varde
Finland	Research Site	Espoo
Finland	Research Site	Helsinki
Finland	Research Site	Jyväskylä
Finland	Research Site	Kuopio
Finland	Research Site	Lahti
Finland	Research Site	Rovaniemi
Finland	Research Site	Seinäjoki
Finland	Research Site	Tampere
Finland	Research Site	Turku
France	Research Site	Antony
France	Research Site	Argenteuil
France	Research Site	Avignon
France	Research Site	Belfort
France	Research Site	Boulogne Billancourt
France	Research Site	Bourges
France	Research Site	Brest
France	Research Site	Brive La Gaillarde
France	Research Site	Caen
France	Research Site	Chambery
France	Research Site	Chambray Les Tours
France	Research Site	Colmar
France	Research Site	Dijon
France	Research Site	Dunkerque
France	Research Site	Haguenau
France	Research Site	Hopital Civil (strasbourg Cedex)
France	Research Site	La Rochelle
France	Research Site	La Source
France	Research Site	Lagny Sur Marne
France	Research Site	Le Chesnay
France	Research Site	Le Coudray
France	Research Site	Le Plessis Robinson
France	Research Site	Marignane
France	Research Site	Marseille
France	Research Site	Metz
France	Research Site	Montfermeil
France	Research Site	Montreuil
France	Research Site	Mulhouse
France	Research Site	Nice
France	Research Site	Paris
France	Research Site	Perpignan
France	Research Site	Quimper
France	Research Site	Reims
France	Research Site	St Brieuc
France	Research Site	St Michel
France	Research Site	Strasbourg Cedex
France	Research Site	Suresnes
France	Research Site	Valence
France	Research Site	Vandoeuvre Les Nancy
Germany	Research Site	Berlin
Germany	Research Site	Bielefeld
Germany	Research Site	Bochum
Germany	Research Site	Bonn
Germany	Research Site	Borken
Germany	Research Site	Cloppenburg
Germany	Research Site	Coburg
Germany	Research Site	Detmold
Germany	Research Site	Dortmund
Germany	Research Site	Essen
Germany	Research Site	Esslingen
Germany	Research Site	Greifswald
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Herrsching
Germany	Research Site	Landshut
Germany	Research Site	Leverkusen
Germany	Research Site	Lubeck
Germany	Research Site	Ludwigshafen
Germany	Research Site	Mainz
Germany	Research Site	Merseburg
Germany	Research Site	Monchengladbach
Germany	Research Site	Muhlheim
Germany	Research Site	Olsberg
Germany	Research Site	Regensburg
Germany	Research Site	Rostock
Germany	Research Site	Stuttgart
Germany	Research Site	Suhl
Germany	Research Site	Warendorf
Greece	Research Site	Athens
Greece	Research Site	Attika
Greece	Research Site	Chalkida
Greece	Research Site	Chania
Greece	Research Site	Chios
Greece	Research Site	Edessa
Greece	Research Site	Elefsina
Greece	Research Site	Heraklion
Greece	Research Site	Ioannina
Greece	Research Site	Larisa
Greece	Research Site	Patra
Greece	Research Site	Ptolemaida
Italy	Research Site	Ancona
Italy	Research Site	Catania
Italy	Research Site	Catanzaro
Italy	Research Site	Ferrara
Italy	Research Site	Firenze
Italy	Research Site	Genova
Italy	Research Site	Massa
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Napoli Caserta
Italy	Research Site	Nuoro
Italy	Research Site	Ospedale di Macerata
Italy	Research Site	Pescara
Italy	Research Site	Prato
Italy	Research Site	Rho
Italy	Research Site	Rimini
Italy	Research Site	Roma
Italy	Research Site	Rovigo
Italy	Research Site	Sassari
Italy	Research Site	Siracusa
Italy	Research Site	Treviso
Italy	Research Site	Udine
Italy	Research Site	Varese
Italy	Research Site	Versilia
Luxembourg	Research Site	Luxembourg
Mexico	Research Site	Cardenas, Tabasco
Mexico	Research Site	Chihuahua
Mexico	Research Site	Chihuahua, Chihuahua
Mexico	Research Site	Durango
Mexico	Research Site	Durango, Durango
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara, Jalisco
Mexico	Research Site	Guanajuato
Mexico	Research Site	Leon Guanajuato
Mexico	Research Site	Merida, Yucatan
Mexico	Research Site	Mexicali, Baja California
Mexico	Research Site	Mexico City
Mexico	Research Site	Monterrey, Nuevo Leon
Mexico	Research Site	Oaxaca, Oaxaca
Mexico	Research Site	Puebla, Puebla
Mexico	Research Site	Queretaro
Mexico	Research Site	Saltillo Coahuila
Mexico	Research Site	San Luis Potosi
Mexico	Research Site	Sinaloa, Culiacan
Mexico	Research Site	Tabasco
Mexico	Research Site	Tijuana B.C.
Mexico	Research Site	Toluca, Estado de Mexico
Mexico	Research Site	Torreon
Mexico	Research Site	Torreon Coahuila
Mexico	Research Site	Xalapa, Veracruz
Netherlands	Research Site	Amstelveen
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Bergen op Zoom
Netherlands	Research Site	Beverwijk
Netherlands	Research Site	Delft
Netherlands	Research Site	Den Bosh
Netherlands	Research Site	Den Haag
Netherlands	Research Site	Doetinchem
Netherlands	Research Site	Goes
Netherlands	Research Site	Haarlem
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Hoofddorp
Netherlands	Research Site	Hoogeveen
Netherlands	Research Site	Meppel
Netherlands	Research Site	Purmerend
Netherlands	Research Site	Stadskanaal
Netherlands	Research Site	Winterswijk
Netherlands	Research Site	Zwolle
Norway	Research Site	Bergen
Norway	Research Site	Bodo
Norway	Research Site	Elverum
Norway	Research Site	Flekkefjord
Norway	Research Site	Forde
Norway	Research Site	Gjovik
Norway	Research Site	Hamar
Norway	Research Site	Hammerfest
Norway	Research Site	Harstad
Norway	Research Site	Haugesund
Norway	Research Site	Honefoss
Norway	Research Site	Kongsvinger
Norway	Research Site	Kristiansund N
Norway	Research Site	Levanger
Norway	Research Site	Lillehammer
Norway	Research Site	Lorenskog
Norway	Research Site	Molde
Norway	Research Site	Oslo
Norway	Research Site	Rjukan
Norway	Research Site	Rud
Norway	Research Site	Skien
Norway	Research Site	Tonsberg
Norway	Research Site	Tromso
Norway	Research Site	Trondheim
Norway	Research Site	Tynset
Poland	Research Site	Bydgoszcz
Poland	Research Site	Elblag
Poland	Research Site	Jelenia Gora
Poland	Research Site	Kalisz
Poland	Research Site	Koszalin
Poland	Research Site	Krakow
Poland	Research Site	Olawa
Poland	Research Site	Olsztyn
Poland	Research Site	Opole
Poland	Research Site	Ostrow Maz.
Poland	Research Site	Poznan
Poland	Research Site	Pruszkow
Poland	Research Site	Radom
Poland	Research Site	Sandomierz
Poland	Research Site	Slupsk
Poland	Research Site	Starogard Gdanski
Poland	Research Site	Tarnow
Poland	Research Site	Torun
Poland	Research Site	Walbrzych
Poland	Research Site	Warszawa
Poland	Research Site	Wloclawek
Poland	Research Site	Wroclaw
Romania	Research Site	Alba Iulia
Romania	Research Site	Arad
Romania	Research Site	Bacau
Romania	Research Site	Baia Mare
Romania	Research Site	Bistrita
Romania	Research Site	Braila
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Buzau
Romania	Research Site	Cluj Napoca
Romania	Research Site	Constanta
Romania	Research Site	Craiova
Romania	Research Site	Drobeta-turnu Severin
Romania	Research Site	Focsani
Romania	Research Site	Galati
Romania	Research Site	Hunedoara
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Piatra Neamt
Romania	Research Site	Pitesti
Romania	Research Site	Ploiesti
Romania	Research Site	Ramnicu Valcea
Romania	Research Site	Sibiu
Romania	Research Site	Slatina
Romania	Research Site	Suceava
Romania	Research Site	Targoviste
Romania	Research Site	Targu Mures
Romania	Research Site	Timisoara
Romania	Research Site	Zalau
Slovenia	Research Site	Ljubljana
Slovenia	Research Site	Maribor
Spain	Research Site	Alcala de Henares
Spain	Research Site	Alcoy
Spain	Research Site	Alicante
Spain	Research Site	Aranjuez
Spain	Research Site	Avila
Spain	Research Site	Barcelona
Spain	Research Site	Baza
Spain	Research Site	Ciudad Real
Spain	Research Site	Coslada
Spain	Research Site	Elche
Spain	Research Site	Elda
Spain	Research Site	Ferrol
Spain	Research Site	Fuenlabrada
Spain	Research Site	Gandia
Spain	Research Site	Gerona
Spain	Research Site	Huelva
Spain	Research Site	Huercal-Overa
Spain	Research Site	Huesca
Spain	Research Site	Igualada
Spain	Research Site	Leon
Spain	Research Site	Lugo
Spain	Research Site	Madrid
Spain	Research Site	Palencia
Spain	Research Site	Pozoblanco
Spain	Research Site	Puertollano
Spain	Research Site	Salamanca
Spain	Research Site	San Juan
Spain	Research Site	San Sebastian de los Reyes
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Segovia
Spain	Research Site	Sevilla
Spain	Research Site	Tarragona
Spain	Research Site	Terrassa
Spain	Research Site	Toledo
Spain	Research Site	Torrevieja
Spain	Research Site	Tortosa
Spain	Research Site	Valencia
Spain	Research Site	Velez-Malaga
Spain	Research Site	Vic
Spain	Research Site	Villa Joyosa
Spain	Research Site	Zaragoza
Turkey	Research Site	Adana
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Canakkale
Turkey	Research Site	Diyarbak?r
Turkey	Research Site	Elaz?g
Turkey	Research Site	Erzurum
Turkey	Research Site	Eskisehir
Turkey	Research Site	Gaziantep
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Kayseri
Turkey	Research Site	Konya
Turkey	Research Site	Malatya
Turkey	Research Site	Manisa
Turkey	Research Site	Mersin
Turkey	Research Site	Samsun
Turkey	Research Site	Sivas
Turkey	Research Site	Trabzon
United Kingdom	Research Site	Airdrie
United Kingdom	Research Site	Antrim
United Kingdom	Research Site	Basingstoke
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Blackburn
United Kingdom	Research Site	Blackpool
United Kingdom	Research Site	Craigavon
United Kingdom	Research Site	Croydon
United Kingdom	Research Site	East Kilbride
United Kingdom	Research Site	Essex
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Harrow
United Kingdom	Research Site	Hastings
United Kingdom	Research Site	Hertfordshire
United Kingdom	Research Site	High Wycombe
United Kingdom	Research Site	Kirkcaldy
United Kingdom	Research Site	Livingston
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Middlesbrough
United Kingdom	Research Site	Morriston Hospital (Swansea)
United Kingdom	Research Site	Newcastle Upon Tyne
United Kingdom	Research Site	Peterborough
United Kingdom	Research Site	Rotherham
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Stevenage
United Kingdom	Research Site	Sutton Coldfield
United Kingdom	Research Site	Worcester
Venezuela	Research Site	Barquisimeto
Venezuela	Research Site	Caracas
Venezuela	Research Site	Coro
Venezuela	Research Site	Maracaibo
Venezuela	Research Site	Maracay
Venezuela	Research Site	Oriente
Venezuela	Research Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Luxembourg,  Mexico,  Netherlands,  Norway,  Poland,  Romania,  Slovenia,  Spain,  Turkey,  United Kingdom,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes		Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)	No
Secondary	Antithrombotic treatments		Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)	No
Secondary	Use of health care resources		Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)	No
Secondary	Quality of life		At index event (baseline) and then at 6 weeks and each 3 months after index event	No