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: December 12, 2013
Last verified: December 2013
  Purpose

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.


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 RUSsia

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 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 600
Study Start Date: July 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients hospitalized and diagnosed with UA, STEMI or NSTEMI

  Eligibility

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

Clinical Practice

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373957

Locations
Russian Federation
Research Site
Barnaul, Russian Federation
Research Site
Cheboksary, Russian Federation
Research Site
Ekaterinburg, Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Kemerovo, Russian Federation
Research Site
Kirov, Russian Federation
Research Site
Krasnodar, Russian Federation
Research Site
Krasnoyarsk, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Murmansk, Russian Federation
Research Site
N.Novgorod, Russian Federation
Research Site
Novosibirsk, Russian Federation
Research Site
Petrozavodsk, Russian Federation
Research Site
Rostov-on-Don, Russian Federation
Research Site
S-Petersburg, Russian Federation
Research Site
Samara, Russian Federation
Research Site
Saratov, Russian Federation
Research site
Tomsk, Russian Federation
Research Site
Tyumen, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Alexey Stepanov AstraZeneca
Principal Investigator: Mikhail Ruda RKNPK
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01373957     History of Changes
Other Study ID Numbers: NIS-CRU-XXX-2011/1
Study First Received: June 13, 2011
Last Updated: December 12, 2013
Health Authority: Russia: Ethics Committee

Keywords provided by AstraZeneca:
Acute Coronary Syndrome
antithrombotic management
STEMI
NSTE-ACS

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 April 17, 2014