Acute Coronary SyndromeEPICOR-RUSNCT01373957
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 19 sites in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 600 participants
- Where
- 19 sitesRussia
- Study dates
- Jul 2011to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinical Practice
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Research Site
Barnaul
Research Site
Cheboksary
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Kirov
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Murmansk
Research Site
N.Novgorod
Research Site
Novosibirsk
Research Site
Petrozavodsk
Research Site
Rostov-on-Don
Research Site
S-Petersburg
Research Site
Samara
Research Site
Saratov
Research site
Tomsk
Research Site
Tyumen
Research Site
Yekaterinburg
About this study
Official title: 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.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, antithrombotic management, STEMI, NSTE-ACS
- Medical subject headings
- Acute Coronary Syndrome, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients hospitalized and diagnosed with UA, STEMI or NSTEMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short- and long-term medication and treatment prescribed by physicians in real-life setting
Measured: up to 2 years
Secondary outcomes (2)
clinical outcome (Cardiovascular events)
Measured: up to 2 years
quality of life (EQ-5D questionnaire)
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexey Stepanov, Study director, AstraZenecaMikhail Ruda, Principal investigator, RKNPK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373957
- Sponsor's protocol ID
- NIS-CRU-XXX-2011/1
- Acronym
- EPICOR-RUS
- Status last verified
- Jul 2014
- First submitted
- 13 Jun 2011
- Last updated
- 11 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28420281
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia
- ClinicalTrials.gov ID
- NCT01373957
- Acronym / sponsor ID
- EPICOR-RUS / NIS-CRU-XXX-2011/1
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, antithrombotic management, STEMI, NSTE-ACS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients hospitalized and diagnosed with UA, STEMI or NSTEMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinical Practice
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short- and long-term medication and treatment prescribed by physicians in real-life setting
Time frame: up to 2 years
2 secondary outcomes
clinical outcome (Cardiovascular events)
Time frame: up to 2 years
quality of life (EQ-5D questionnaire)
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2014.
- Derived from this study: PubMed 28420281Ruda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexey Stepanov study director
AstraZeneca
Mikhail Ruda principal investigator
RKNPK
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 19 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short- and long-term medication and treatment prescribed by physicians in real-life setting (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01373957, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.