Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge (EPICOR)
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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 |
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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 |
- 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 ]
- 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 ]
Estimated Enrollment: | 10600 |
Study Start Date: | September 2010 |
Estimated Study Completion Date: | March 2013 |
Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.
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.
Show 411 Study Locations
Study Director: | Mónica Tafalla | Medical Department.AstraZeneca Spain |
No publications provided
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: | September 5, 2012 |
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:
Angina, Unstable Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Myocardial Infarction Acute Coronary Syndrome Angina Pectoris Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Arteriosclerosis Arterial Occlusive Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on October 17, 2012