Clinical trial NCT01171404: Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge
Official title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-07-28
Enrollment: 10568
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes
timeFrame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
Secondary outcomes:
measure: Antithrombotic treatments
timeFrame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
measure: Use of health care resources
timeFrame: Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)
measure: Quality of life
timeFrame: At index event (baseline) and then at 6 weeks and each 3 months after index event
Other outcomes:
Locations:
city: Avellaneda
country: Argentina
facility: Research Site
city: Bahia Blanca
country: Argentina
facility: Research Site
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Research Site
city: Ciudadela
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: Corrientes
country: Argentina
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city: General Roca
country: Argentina
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city: Mar del Plata
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
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city: Monteros
country: Argentina
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city: Quilmes
country: Argentina
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city: Rosario
country: Argentina
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country: Argentina
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city: San Isidro
country: Argentina
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city: San Miguel de Tucuman
country: Argentina
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city: San Salvador de Jujuy
country: Argentina
facility: Research Site
city: (Jette) Bruxelles
country: Belgium
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
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city: Brasschaat
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
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city: Brussel
country: Belgium
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city: Bruxelles
country: Belgium
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city: Charleroi
country: Belgium
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city: Chenee
country: Belgium
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city: Dendermonde
country: Belgium
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city: Edegem
country: Belgium
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country: Belgium
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city: Genk
country: Belgium
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city: La Louviere
country: Belgium
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city: Leuven
country: Belgium
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country: Belgium
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city: Merksem
country: Belgium
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city: Mol
country: Belgium
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city: Mons
country: Belgium
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city: Montigny-le-Tilleul
country: Belgium
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city: Namur
country: Belgium
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city: Oostende
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Ronse
country: Belgium
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city: Seraing
country: Belgium
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country: Belgium
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city: Soignies
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Aracaju
country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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city: Aalborg
country: Denmark
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city: Aarhus
country: Denmark
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city: Arhus N
country: Denmark
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city: Esbjerg
country: Denmark
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city: Fredericia
country: Denmark
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city: Frederiksberg
country: Denmark
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city: Kobenhavn NV
country: Denmark
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city: Odense C
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: Finland
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country: France
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city: Argenteuil
country: France
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country: France
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city: Belfort
country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Chambray Les Tours
country: France
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city: Colmar
country: France
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city: Dijon
country: France
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city: Dunkerque
country: France
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city: Haguenau
country: France
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city: Hopital Civil (strasbourg Cedex)
country: France
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city: La Rochelle
country: France
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city: La Source
country: France
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city: Lagny Sur Marne
country: France
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country: France
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country: France
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city: Le Plessis Robinson
country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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country: France
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city: Vandoeuvre Les Nancy
country: France
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city: Berlin
country: Germany
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city: Bielefeld
country: Germany
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country: Germany
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country: Germany
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city: Borken
country: Germany
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city: Cloppenburg
country: Germany
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city: Coburg
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Ludwigshafen
country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Rostock
country: Germany
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city: Stuttgart
country: Germany
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city: Suhl
country: Germany
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city: Warendorf
country: Germany
facility: Research Site
city: Athens
country: Greece
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city: Attika
country: Greece
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city: Chalkida
country: Greece
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city: Chania
country: Greece
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city: Chios
country: Greece
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city: Edessa
country: Greece
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city: Elefsina
country: Greece
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city: Heraklion
country: Greece
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city: Ioannina
country: Greece
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city: Larisa
country: Greece
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city: Patra
country: Greece
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city: Ptolemaida
country: Greece
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city: Ancona
country: Italy
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city: Catania
country: Italy
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city: Catanzaro
country: Italy
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city: Ferrara
country: Italy
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city: Firenze
country: Italy
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city: Genova
country: Italy
facility: Research Site
city: Massa
country: Italy
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city: Milano
country: Italy
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city: Napoli Caserta
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Nuoro
country: Italy
facility: Research Site
city: Ospedale di Macerata
country: Italy
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city: Pescara
country: Italy
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city: Prato
country: Italy
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city: Rho
country: Italy
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city: Rimini
country: Italy
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city: Roma
country: Italy
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city: Rovigo
country: Italy
facility: Research Site
city: Sassari
country: Italy
facility: Research Site
city: Siracusa
country: Italy
facility: Research Site
city: Treviso
country: Italy
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city: Udine
country: Italy
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city: Varese
country: Italy
facility: Research Site
city: Versilia
country: Italy
facility: Research Site
city: Luxembourg
country: Luxembourg
facility: Research Site
city: Cardenas, Tabasco
country: Mexico
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city: Chihuahua, Chihuahua
country: Mexico
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city: Chihuahua
country: Mexico
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city: Durango, Durango
country: Mexico
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country: Mexico
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city: Guadalajara, Jalisco
country: Mexico
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city: Guadalajara
country: Mexico
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city: Guanajuato
country: Mexico
facility: Research Site
city: Leon Guanajuato
country: Mexico
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city: Merida, Yucatan
country: Mexico
facility: Research Site
city: Mexicali, Baja California
country: Mexico
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
city: Monterrey, Nuevo Leon
country: Mexico
facility: Research Site
city: Oaxaca, Oaxaca
country: Mexico
facility: Research Site
city: Puebla, Puebla
country: Mexico
facility: Research Site
city: Queretaro
country: Mexico
facility: Research Site
city: Saltillo Coahuila
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
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city: Sinaloa, Culiacan
country: Mexico
facility: Research Site
city: Tabasco
country: Mexico
facility: Research Site
city: Tijuana B.C.
country: Mexico
facility: Research Site
city: Toluca, Estado de Mexico
country: Mexico
facility: Research Site
city: Torreon Coahuila
country: Mexico
facility: Research Site
city: Torreon
country: Mexico
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city: Xalapa, Veracruz
country: Mexico
facility: Research Site
city: Amstelveen
country: Netherlands
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city: Amsterdam
country: Netherlands
facility: Research Site
city: Bergen op Zoom
country: Netherlands
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city: Beverwijk
country: Netherlands
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city: Delft
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city: Den Bosh
country: Netherlands
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city: Den Haag
country: Netherlands
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city: Doetinchem
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city: Goes
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city: Heerlen
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city: Hoofddorp
country: Netherlands
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city: Hoogeveen
country: Netherlands
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city: Stadskanaal
country: Netherlands
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city: Winterswijk
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city: Bergen
country: Norway
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city: Bodo
country: Norway
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city: Elverum
country: Norway
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city: Flekkefjord
country: Norway
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country: Norway
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city: Kongsvinger
country: Norway
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country: Poland
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country: Poland
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country: Poland
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country: Poland
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Romania
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country: Spain
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city: East Kilbride
country: United Kingdom
facility: Research Site
city: Essex
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Hastings
country: United Kingdom
facility: Research Site
city: Hertfordshire
country: United Kingdom
facility: Research Site
city: High Wycombe
country: United Kingdom
facility: Research Site
city: Kirkcaldy
country: United Kingdom
facility: Research Site
city: Livingston
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Middlesbrough
country: United Kingdom
facility: Research Site
city: Morriston Hospital (Swansea)
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Rotherham
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Sutton Coldfield
country: United Kingdom
facility: Research Site
city: Worcester
country: United Kingdom
facility: Research Site
city: Barquisimeto
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Coro
country: Venezuela
facility: Research Site
city: Maracaibo
country: Venezuela
facility: Research Site
city: Maracay
country: Venezuela
facility: Research Site
city: Oriente
country: Venezuela
facility: Research Site
city: Valencia
country: Venezuela
facility: Research Site
Study officials:
affiliation: Medical Department.AstraZeneca Spain
name: Mónica Tafalla
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.