NCT01373957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

June 13, 2011

Last Update Submit

July 10, 2014

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndromeantithrombotic managementSTEMINSTE-ACS

Outcome Measures

Primary Outcomes (1)

  • Short- and long-term medication and treatment prescribed by physicians in real-life setting

    up to 2 years

Secondary Outcomes (2)

  • clinical outcome (Cardiovascular events)

    up to 2 years

  • quality of life (EQ-5D questionnaire)

    up to 2 years

Study Arms (1)

1

Patients hospitalized and diagnosed with UA, STEMI or NSTEMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Clinical Practice

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Barnaul, Russia

Location

Research Site

Cheboksary, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Kemerovo, Russia

Location

Research Site

Kirov, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Krasnoyarsk, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Murmansk, Russia

Location

Research Site

N.Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Petrozavodsk, Russia

Location

Research Site

Rostov-on-Don, Russia

Location

Research Site

S-Petersburg, Russia

Location

Research Site

Samara, Russia

Location

Research Site

Saratov, Russia

Location

Research site

Tomsk, Russia

Location

Research Site

Tyumen, Russia

Location

Research Site

Yekaterinburg, Russia

Location

Related Publications (1)

  • 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.

    PMID: 28420281DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Alexey Stepanov

    AstraZeneca

    STUDY DIRECTOR

  • Mikhail Ruda

    RKNPK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2011

First Posted

June 15, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

RU(19)