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

Acute Coronary Syndrome Clinical Trial

— EPICOR-RUS  

Official title:

Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01373957
• Other study ID #: NIS-CRU-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: June 13, 2011
• Last updated: July 10, 2014
• Start date: July 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short- and long-term medication and treatment prescribed by physicians in real-life setting		up to 2 years	No
Secondary	clinical outcome (Cardiovascular events)		up to 2 years	No
Secondary	quality of life (EQ-5D questionnaire)		up to 2 years	No