Clinical trial NCT01373957: Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia
Official title: Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
antithrombotic management
STEMI
NSTE-ACS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-06-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical Practice

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.


Eligibility 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.

Primary outcomes:
measure: Short- and long-term medication and treatment prescribed by physicians in real-life setting
timeFrame: up to 2 years
Secondary outcomes:
measure: clinical outcome (Cardiovascular events)
timeFrame: up to 2 years
measure: quality of life (EQ-5D questionnaire)
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Barnaul
country: Russian Federation
facility: Research Site
city: Cheboksary
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Kirov
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Murmansk
country: Russian Federation
facility: Research Site
city: N.Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: S-Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research site
city: Tyumen
country: Russian Federation
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Alexey Stepanov
role: STUDY_DIRECTOR
affiliation: RKNPK
name: Mikhail Ruda
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruda MY, Averkov OV, Khomitskaya YV. Long-term follow-up of antithrombotic management patterns in patients with acute coronary syndrome in Russia: an observational study (EPICOR-RUS study). Curr Med Res Opin. 2017 Jul;33(7):1269-1276. doi: 10.1080/03007995.2017.1313214. Epub 2017 Apr 19.