Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia (EPICOR-RUS)
This study is ongoing, but not recruiting participants.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01373957
First received: June 13, 2011
Last updated: March 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition |
|---|
|
Acute Coronary Syndrome |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia |
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Short- and long-term medication and treatment prescribed by physicians in real-life setting [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- clinical outcome (Cardiovascular events) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
- quality of life (EQ-5D questionnaire) [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 600 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Patients hospitalized and diagnosed with UA, STEMI or NSTEMI
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Clinical Practice
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373957
Locations
| 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, Russian Federation | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Alexey Stepanov | AstraZeneca |
| Principal Investigator: | Mikhail Ruda | RKNPK |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01373957 History of Changes |
| Other Study ID Numbers: | NIS-CRU-XXX-2011/1 |
| Study First Received: | June 13, 2011 |
| Last Updated: | March 1, 2013 |
| Health Authority: | Russia: Ethics Committee |
Keywords provided by AstraZeneca:
|
Acute Coronary Syndrome antithrombotic management STEMI NSTE-ACS |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris |
Vascular Diseases Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013