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Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia (EPICOR-RUS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01373957
First received: June 13, 2011
Last updated: March 1, 2013
Last verified: March 2013
History of Changes

June 13, 2011
March 1, 2013
July 2011
March 2014   (final data collection date for primary outcome measure)
Short- and long-term medication and treatment prescribed by physicians in real-life setting [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01373957 on ClinicalTrials.gov Archive Site
  • clinical outcome (Cardiovascular events) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • quality of life (EQ-5D questionnaire) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia
Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia

EPICOR-RUS is a multi-centre, observational, prospective, longitudinal cohort study which will include patients, in a real-life setting, who are hospitalized for acute coronary syndrome (ACS) within 24 hours of symptom onset and who have a final diagnosis of Unstable Angina (UA), ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI). Patients will undergo clinical assessments and receive the standard medical care as determined by the treating cardiologist. Patients will not receive experimental intervention or experimental treatment as a consequence of their participation in the EPICOR-RUS observational study.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Clinical Practice
Acute Coronary Syndrome
Not Provided
1
Patients hospitalized and diagnosed with UA, STEMI or NSTEMI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
March 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be 18 years of age or older of either gender or race
  • Diagnosis of STEMI, NSTEMI or UA confirmed using the following definitions

Exclusion Criteria:

  • UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal (GI) bleeding or post-Percutaneous coronary intervention (PCI).
  • UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.
  • 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).
  • Already included in the EPICOR-RUS study.
  • Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.
  • Current participation in a clinical trial.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01373957
NIS-CRU-XXX-2011/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: Alexey Stepanov AstraZeneca
Principal Investigator: Mikhail Ruda RKNPK
AstraZeneca
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP