Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT01373957
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-14
• Study First Posted: 2011-06-15
• Study Start: 2011-07
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short- and long-term medication and treatment prescribed by physicians in real-life setting	up to 2 years

Secondary Outcome Measures

Name	Time	Method
clinical outcome (Cardiovascular events)	up to 2 years
quality of life (EQ-5D questionnaire)	up to 2 years

Trial Locations

Locations (2)

Research Site; 🇷🇺 Tyumen, Russian Federation

Research site; 🇷🇺 Tomsk, Russian Federation