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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01361386
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date May 23, 2011
First Posted Date May 26, 2011
Last Update Posted Date June 16, 2014
Study Start Date June 2011
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 25, 2011)
short- and long-term medication and treatment prescribed by physicians in real-life setting [ Time Frame: up to 3 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2011)
  • clinical outcome (Cardiovascular events) [ Time Frame: up to 3 years ]
  • cost of hospitalization [ Time Frame: up to 3 years ]
  • quality of life (EQ-5D questionnaire) [ Time Frame: up to 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-tErm Follow-uP of antithrombotIc Management Patterns In Acute CORonary Syndrome Patients in Asia
Official Title Long-Term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Asia
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition Acute Coronary Syndrome
Intervention Not Provided
Study Groups/Cohorts 1
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 24, 2013)
13011
Original Estimated Enrollment
 (submitted: May 25, 2011)
13620
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China,   India,   Korea, Republic of,   Malaysia,   Singapore,   Thailand,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number NCT01361386
Other Study ID Numbers NIS-CAP-XXX-2011/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Director: Guy Yeoman AstraZeneca
Study Chair: Prof. Huo Yong Peking University 1st Hospital
Study Chair: Jayanti Visvanathan AstraZeneca
PRS Account AstraZeneca
Verification Date June 2014