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Long-tErm Follow-uP of antithrombotIc Management Patterns In Acute CORonary Syndrome Patients in Asia (EPICOR ASIA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01361386
First received: May 23, 2011
Last updated: May 11, 2012
Last verified: May 2012
History of Changes
  Purpose

The purpose of this study is to describe the short-and long-tern (i.e. up to 2 years following the index event) AMPs in patients hospitalized for an acute coronary syndrome (i.e. STEMI or NSTE-ACS), and to document clinical outcomes, economic aspects and impact on quality of life of these AMPs in a 'real-life' setting.


Condition
Acute Coronary Syndrome

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 in Asia

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • short- and long-term medication and treatment prescribed by physicians in real-life setting [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical outcome (Cardiovascular events) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • cost of hospitalization [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
  • quality of life (EQ-5D questionnaire) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 13620
Study Start Date: June 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Asian patients hospitalized for ACS within 48 hours of symptom onset and who have a final diagnosis of unstable angina (UA), STEMI or non-ST-segment elevation myocardial infarction (NSTEMI).

Criteria

Inclusion Criteria:

  • Written informed consent has been provided.
  • Diagnosis of STEMI, NSTEMI or UA
  • Hospitalization for the first time within 48 hours of onset of symptoms.

Exclusion Criteria:

  • UA, STEMI, NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
  • Current participation in a randomised interventional clinical trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361386

  Show 109 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Guy Yeoman AstraZeneca
Study Chair: Prof. Huo Yong Peking University 1st Hospital
Study Chair: Jayanti Visvanathan AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01361386     History of Changes
Other Study ID Numbers: NIS-CAP-XXX-2011/1
Study First Received: May 23, 2011
Last Updated: May 11, 2012
Health Authority: Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Long-term follow up
Antithrombotic management patterns
Acute Coronary Syndrome
Asia
quality of life

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013