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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 February 2013 |
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Main ID: |
NCT01373957 |
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Date of registration:
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13/06/2011 |
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Primary sponsor: |
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Public title:
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Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia
EPICOR-RUS |
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Scientific title:
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Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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600 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01373957 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Russian Federation
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Contacts
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Name:
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Alexey Stepanov |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Name:
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Mikhail Ruda |
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Address:
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Telephone:
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Email:
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Affiliation:
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RKNPK |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Coronary Syndrome
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Primary Outcome(s)
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Short- and long-term medication and treatment prescribed by physicians in real-life setting
[Time Frame: up to 2 years]
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Secondary Outcome(s)
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clinical outcome (Cardiovascular events)
[Time Frame: up to 2 years]
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quality of life (EQ-5D questionnaire)
[Time Frame: up to 2 years]
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Secondary ID(s)
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NIS-CRU-XXX-2011/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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