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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

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) ]

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) ]
  • 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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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:
Syndrome
Acute Coronary Syndrome
Infarction
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Angina, Unstable
Disease
Pathologic Processes
Ischemia
Necrosis
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 23, 2017