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

Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01171404
Collaborator
(none)
10,568
411
30
25.7
0.9

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
10568 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

Arm Intervention/Treatment
1

Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI

Outcome Measures

Primary Outcome Measures

  1. 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)]

Secondary Outcome Measures

  1. Antithrombotic treatments [Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)]

  2. 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)]

  3. Quality of life [At index event (baseline) and then at 6 weeks and each 3 months after index event]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Research Site Avellaneda Argentina
2 Research Site Bahia Blanca Argentina
3 Research Site Ciudad Autonoma de Buenos Aires Argentina
4 Research Site Ciudadela Argentina
5 Research Site Cordoba Argentina
6 Research Site Corrientes Argentina
7 Research Site General Roca Argentina
8 Research Site Mar del Plata Argentina
9 Research Site Mendoza Argentina
10 Research Site Monteros Argentina
11 Research Site Quilmes Argentina
12 Research Site Rosario Argentina
13 Research Site Salta Argentina
14 Research Site San Isidro Argentina
15 Research Site San Miguel de Tucuman Argentina
16 Research Site San Salvador de Jujuy Argentina
17 Research Site (Jette) Bruxelles Belgium
18 Research Site Aalst Belgium
19 Research Site Antwerpen Belgium
20 Research Site Brasschaat Belgium
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90 Research Site Antony France
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410 Research Site Oriente Venezuela
411 Research Site Valencia Venezuela

Sponsors and Collaborators

  • AstraZeneca

Investigators

  • Study Director: Mónica Tafalla, Medical Department.AstraZeneca Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01171404
Other Study ID Numbers:
  • NIS-CEU-DUM-2009/1
First Posted:
Jul 28, 2010
Last Update Posted:
Apr 17, 2013
Last Verified:
Apr 1, 2013

Study Results

No Results Posted as of Apr 17, 2013