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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01171404
First received: July 27, 2010
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition
ACS
Acute Coronary Syndrome
Myocardial Infarction
Unstable Angina
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At index event (baseline) and then at 6 weeks and each 3 months after index event ] [ Designated as safety issue: No ]

Enrollment: 10568
Study Start Date: September 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01171404

  Show 411 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Mónica Tafalla Medical Department.AstraZeneca Spain
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01171404     History of Changes
Other Study ID Numbers: NIS-CEU-DUM-2009/1
Study First Received: July 27, 2010
Last Updated: April 16, 2013
Health Authority: Belgium: Institutional Review Board
Brazil: National Committee of Ethics in Research
Brazil: Ethics Committee
Denmark: Danish Dataprotection Agency
Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health
France: Institutional Ethical Committee
France: French Data Protection Authority
Germany: Ethics Commission
Greece: Ethics Committee
Greece: Ministry of Health and Welfare
Italy: Ethics Committee
Mexico: Ethics Committee
Netherlands: Independent Ethics Committee
Norway:National Committee for Medical and Health Research Ethics
Poland: Ethics Committee
Portugal: Ethics Committee for Clinical Research
Romania: National Medicines Agency
Romania: Ministry of Public Health
Slovenia: Ethics Committee
Spain: Ethics Committee
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health
United Kingdom: Research Ethics Committee
Venezuela: Ethics Committee

Keywords provided by AstraZeneca:
Acute coronary syndrome
heart attack
myocardial infarction
ACS long-tem follow up
antithrombotic management
quality of life
Antithrombotic

Additional relevant MeSH terms:
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Syndrome
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Ischemia
Pathologic Processes
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Disease
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014