Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-20 @ 5:57 PM
Study NCT ID:
NCT01373957
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2011-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-10', 'studyFirstSubmitDate': '2011-06-13', 'studyFirstSubmitQcDate': '2011-06-14', 'lastUpdatePostDateStruct': {'date': '2014-07-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short- and long-term medication and treatment prescribed by physicians in real-life setting', 'timeFrame': 'up to 2 years'}], 'secondaryOutcomes': [{'measure': 'clinical outcome (Cardiovascular events)', 'timeFrame': 'up to 2 years'}, {'measure': 'quality of life (EQ-5D questionnaire)', 'timeFrame': 'up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Coronary Syndrome', 'antithrombotic management', 'STEMI', 'NSTE-ACS'], 'conditions': ['Acute Coronary Syndrome']}, 'referencesModule': {'references': [{'pmid': '28420281', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Clinical Practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be 18 years of age or older of either gender or race\n* Diagnosis of STEMI, NSTEMI or UA confirmed using the following definitions\n\nExclusion Criteria:\n\n* UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or gastrointestinal (GI) bleeding or post-Percutaneous coronary intervention (PCI).\n* UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons.\n* 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).\n* Already included in the EPICOR-RUS study.\n* Presence of serious/severe co-morbidities in the opinion of the investigator which may limit short term (i.e. 6 month) life expectancy.\n* Current participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT01373957', 'acronym': 'EPICOR-RUS', 'briefTitle': 'Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients in Russia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Long-tErm Follow-uP of Antithrombotic Management Patterns In Acute CORonary Syndrome Patients in RUSsia', 'orgStudyIdInfo': {'id': 'NIS-CRU-XXX-2011/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients hospitalized and diagnosed with UA, STEMI or NSTEMI'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barnaul', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.36199, 'lon': 83.72786}}, {'city': 'Cheboksary', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.13218, 'lon': 47.246}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Kemerovo', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.35417, 'lon': 86.10435}}, {'city': 'Kirov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 58.59809, 'lon': 49.65783}}, {'city': 'Krasnodar', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 45.04534, 'lon': 38.98178}}, {'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Murmansk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 68.96778, 'lon': 33.09922}}, {'city': 'N.Novgorod', 'country': 'Russia', 'facility': 'Research Site'}, {'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}, {'city': 'Petrozavodsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 61.78491, 'lon': 34.34691}}, {'city': 'Rostov-on-Don', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 47.21997, 'lon': 39.70769}}, {'city': 'S-Petersburg', 'country': 'Russia', 'facility': 'Research Site'}, {'city': 'Samara', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}, {'city': 'Saratov', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 51.54048, 'lon': 45.9901}}, {'city': 'Tomsk', 'country': 'Russia', 'facility': 'Research site', 'geoPoint': {'lat': 56.50049, 'lon': 84.98216}}, {'city': 'Tyumen', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.15222, 'lon': 65.52722}}, {'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}], 'overallOfficials': [{'name': 'Alexey Stepanov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Mikhail Ruda', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RKNPK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}