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

July 10, 2014 updated by: AstraZeneca

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical Practice

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Patients hospitalized and diagnosed with UA, STEMI or NSTEMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short- and long-term medication and treatment prescribed by physicians in real-life setting
Time Frame: up to 2 years
up to 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical outcome (Cardiovascular events)
Time Frame: up to 2 years
up to 2 years
quality of life (EQ-5D questionnaire)
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Mikhail Ruda, RKNPK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

June 13, 2011

First Submitted That Met QC Criteria

June 14, 2011

First Posted (Estimate)

June 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-CRU-XXX-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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