Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT01171404
Status:
COMPLETED
Last Update Posted:
2013-04-17
First Post:
2010-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000789', 'term': 'Angina, Unstable'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'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'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10568}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-16', 'studyFirstSubmitDate': '2010-07-27', 'studyFirstSubmitQcDate': '2010-07-27', 'lastUpdatePostDateStruct': {'date': '2013-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical outcomes (ischemic and bleeding) incidence and time to these clinical outcomes', 'timeFrame': 'Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)'}], 'secondaryOutcomes': [{'measure': 'Antithrombotic treatments', 'timeFrame': 'Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)'}, {'measure': 'Use of health care resources', 'timeFrame': 'Longitudinal during 2 years after index event (phone calls to the patients at 6 weeks and each 3 months after index event)'}, {'measure': 'Quality of life', 'timeFrame': 'At index event (baseline) and then at 6 weeks and each 3 months after index event'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute coronary syndrome', 'heart attack', 'myocardial infarction', 'ACS long-tem follow up', 'antithrombotic management', 'quality of life', 'Antithrombotic'], 'conditions': ['ACS', 'Acute Coronary Syndrome', 'Myocardial Infarction', 'Unstable Angina', 'Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '33537947', 'type': 'DERIVED', 'citation': 'Huo Y, Van de Werf F, Han Y, Rossello X, Pocock SJ, Chin CT, Lee SW, Li Y, Jiang J, Vega AM, Medina J, Bueno H. Long-Term Antithrombotic Therapy and Clinical Outcomes in Patients with Acute Coronary Syndrome and Renal Impairment: Insights from EPICOR and EPICOR Asia. Am J Cardiovasc Drugs. 2021 Jul;21(4):471-482. doi: 10.1007/s40256-020-00447-5. Epub 2021 Feb 4.'}, {'pmid': '33420682', 'type': 'DERIVED', 'citation': 'Martin-Asenjo R, Gregson J, Rossello X, Van de Werf F, Medina J, Danchin N, Pocock S, Bueno H. Number of Antithrombotic Drugs Used Early and In-hospital Outcomes in Acute Coronary Syndromes. J Cardiovasc Transl Res. 2021 Aug;14(4):790-798. doi: 10.1007/s12265-020-10094-5. Epub 2021 Jan 8.'}, {'pmid': '30588886', 'type': 'DERIVED', 'citation': 'Stepinska J, Wojtkowska I, Annemans L, Danchin N, Pocock SJ, de Werf FV, Medina J, Bueno H. Long-Term Outcome of Acute Coronary Syndromes in Patients on Chronic Oral Anticoagulants: Data from the EPICOR Study. Curr Vasc Pharmacol. 2020;18(1):92-99. doi: 10.2174/1570161117666181227122355.'}, {'pmid': '27885830', 'type': 'DERIVED', 'citation': 'Bardaji A, Leal M, Arrarte V, Garcia-Moll X, Perez de Isla L, Bueno H. Extended dual antiplatelet therapy after acute coronary syndrome in Spain: Results from the EPICOR study. Cardiovasc Ther. 2017 Apr;35(2). doi: 10.1111/1755-5922.12237.'}, {'pmid': '27504002', 'type': 'DERIVED', 'citation': 'Bueno H, Pocock S, Danchin N, Annemans L, Gregson J, Medina J, Van de Werf F. International patterns of dual antiplatelet therapy duration after acute coronary syndromes. Heart. 2017 Jan 15;103(2):132-138. doi: 10.1136/heartjnl-2016-309509. Epub 2016 Aug 8.'}, {'pmid': '27127635', 'type': 'DERIVED', 'citation': 'Annemans L, Danchin N, Van de Werf F, Pocock S, Licour M, Medina J, Bueno H. Prehospital and in-hospital use of healthcare resources in patients surviving acute coronary syndromes: an analysis of the EPICOR registry. Open Heart. 2016 Feb 24;3(1):e000347. doi: 10.1136/openhrt-2015-000347. eCollection 2016.'}, {'pmid': '26853249', 'type': 'DERIVED', 'citation': 'Beauloye C, Vrolix M, Claeys MJ, van de Borne P, Vandendriessche E, Van De Werf F. Pre-hospital management of acute coronary syndrome patients in Belgium and Luxembourg and other Western European countries. Acta Cardiol. 2016 Feb;71(1):15-24. doi: 10.2143/AC.71.1.3132093.'}, {'pmid': '25374386', 'type': 'DERIVED', 'citation': 'Zeymer U, Heuer H, Schwimmbeck P, Genth-Zotz S, Wolff K, Nienaber CA; EPICOR Investigators. Guideline-adherent therapy in patients with acute coronary syndromes. The EPICOR registry in Germany. Herz. 2015 Mar;40 Suppl 1:27-35. doi: 10.1007/s00059-014-4161-7. Epub 2014 Nov 7.'}, {'pmid': '25301783', 'type': 'DERIVED', 'citation': 'Pocock S, Bueno H, Licour M, Medina J, Zhang L, Annemans L, Danchin N, Huo Y, Van de Werf F. Predictors of one-year mortality at hospital discharge after acute coronary syndromes: A new risk score from the EPICOR (long-tErm follow uP of antithrombotic management patterns In acute CORonary syndrome patients) study. Eur Heart J Acute Cardiovasc Care. 2015 Dec;4(6):509-17. doi: 10.1177/2048872614554198. Epub 2014 Oct 9.'}, {'pmid': '23237128', 'type': 'DERIVED', 'citation': 'Bueno H, Danchin N, Tafalla M, Bernaud C, Annemans L, Van de Werf F. EPICOR (long-tErm follow-up of antithrombotic management Patterns In acute CORonary syndrome patients) study: rationale, design, and baseline characteristics. Am Heart J. 2013 Jan;165(1):8-14. doi: 10.1016/j.ahj.2012.10.018. Epub 2012 Nov 20.'}]}, 'descriptionModule': {'briefSummary': "The aim of this international study is to describe the short- and long-term (i.e. up to 2 years following the index event) antithrombotic management patterns (AMPs) in patients hospitalized for acute coronary syndromes (ST segment elevation myocardial infarction (STEMI), Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS)), and to document the impact of AMPs in clinical outcomes, economic variables and quality of life in a 'real-life' setting and to compare these between sites, countries and regions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized within 24 hours of onset of symptoms and diagnosed with unstable angina (UA), STEMI or non-STEMI(NSTEMI). Patients will be invited to participate by the hospital (Academic or Community) which is going to discharge the patient.\n\nParticipating investigators will belong to hospitals (Academic, Community, with/without cathlab, etc), in the proportion representing the reality of where this kind of patients are managed in each country.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of myocardial infarction or unstable angina\n* Hospitalized for the first time within 24 hours of onset of symptoms\n\nExclusion Criteria:\n\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* Current participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT01171404', 'acronym': 'EPICOR', 'briefTitle': 'Study Evaluating How Patients With Acute Coronary Syndrome Are Managed During 2 Years After Discharge', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Long-term Follow-up of Antithrombotic Management Patterns in Acute Coronary Syndrome Patients', 'orgStudyIdInfo': {'id': 'NIS-CEU-DUM-2009/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patients, older than 18, hospitalized within 24 hours of onset of symptoms and diagnosed with UA, STEMI or NSTEMI'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Avellaneda', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -29.11761, 'lon': -59.65834}}, {'city': 'Bahía Blanca', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -38.7176, 'lon': -62.26545}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Ciudadela', 'country': 'Argentina', 'facility': 'Research Site', 'geoPoint': {'lat': 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