Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-04 @ 10:36 PM
Study NCT ID:
NCT02354456
Status:
UNKNOWN
Last Update Posted:
2016-01-21
First Post:
2015-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation in Turkey: Epidemiologic Registry-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of dead patients', 'timeFrame': '1 year'}, {'measure': 'Number of patients with stroke', 'timeFrame': '1 year'}, {'measure': 'Number of patients with major haemorrhage', 'timeFrame': '1 year'}, {'measure': 'Number of hospitalization', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Number of patients with time in therapeutic INR range', 'timeFrame': '1 year', 'description': 'Time in therapeutic INR range calculated according to Rosendaal method'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial fibrillation', 'epidemiology', 'antiocaogulation'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '23799558', 'type': 'BACKGROUND', 'citation': 'Kaya H, Ertas F, Kaya Z, Kahya Eren N, Yuksel M, Koroglu B, Kose N, Yildiz A, Cimen T, Ulgen MS. Epidemiology, anticoagulant treatment and risk of thromboembolism in patients with valvular atrial fibrillation: Results from Atrial Fibrillation in Turkey: Epidemiologic Registry (AFTER). Cardiol J. 2014;21(2):158-62. doi: 10.5603/CJ.a2013.0085. Epub 2013 Jun 25.'}, {'pmid': '23677730', 'type': 'BACKGROUND', 'citation': 'Ertas F, Eren NK, Kaya H, Aribas A, Acar G, Kanadasi M, Gedik S, Oylumlu M, Yuksel M, Ulgen MS; AFTER Investigators. The atrial fibrillation in Turkey: Epidemiologic Registry (AFTER). Cardiol J. 2013;20(4):447-52. doi: 10.5603/CJ.a2013.0055. Epub 2013 May 15.'}, {'pmid': '23770747', 'type': 'BACKGROUND', 'citation': 'Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.'}, {'pmid': '25169015', 'type': 'BACKGROUND', 'citation': 'Yamashita T, Inoue H, Okumura K, Atarashi H, Origasa H; J-RHYTHM Registry Investigators. Warfarin anticoagulation intensity in Japanese nonvalvular atrial fibrillation patients: a J-RHYTHM Registry analysis. J Cardiol. 2015 Mar;65(3):175-7. doi: 10.1016/j.jjcc.2014.07.013. Epub 2014 Aug 26.'}, {'pmid': '25782122', 'type': 'DERIVED', 'citation': 'Ertas F, Kaya H, Yildiz A, Davutoglu V, Kiris A, Dinc L, Kafes H, Avci A, Calapkorur B, Ertas G, Gul M, Kahraman Ay N, Bulur S, Durukan M, Eren M, Ilhan I, Kucuk M, Ozpelit E, Simsek H, Ucar FM, Yildiz A, Sahin DY, Ayhan E, Caglayan CE, Gungor H, Ozyurtlu F, Sen N, Vatan B, Vatansever F, Kobat MA, Temiz A, Taylan G, Donmez I, Erkus ME, Soylemez S, Zengin H, Gunduz M, Tuncez A, Karavelioglu Y, Gokdeniz T, Koza Y, Aktop Z, Katlandur H, Karaca Ozer P, Yuksel M, Acet H, Cil H, Alan S, Toprak N. An epidemiological study to evaluate the use of vitamin K antagonists and new oral anticoagulants among non-valvular atrial fibrillation patients in Turkey- AFTER-2 study design. Turk Kardiyol Dern Ars. 2015 Mar;43(2):169-77. doi: 10.5543/tkda.2015.35984.'}]}, 'descriptionModule': {'briefSummary': 'Atrial fibrillation (AF) is one of the most common cause of preventable ischemic stroke and associated with increased cardiovascular morbidity and mortality. Our previous AFTER study demonstrated the general epidemiological data about the patients with valvular and nonvalvular AF in Turkey. However, data is lacking about the use of new oral anticoagulants (NOACs), time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management modality in our country. In this multicenter trial the investigators aimed to analyze, follow and evaluate the epidemiological data in non-valvular AF patients.', 'detailedDescription': 'Atrial fibrillation (AF) is the most common cause of preventable stroke and strongly associated with increased cardiovascular morbidity and mortality with a prevalence of 1-2% in general population.The first multicenter trial in AF patients in our country, Atrial Fibrillation in Turkey: Epidemiologic Registry (AFTER) study, showed that 40% of non-valvular AF patients were on warfarin therapy with an effective INR rate of 37% and the most frequent cause of warfarin underuse was physician neglect. Yet, the use of new oral anticoagulants, time in therapeutic INR range (TTR) in warfarin users and the main management modality (rhythm or rate control) in AF patients have not been studied in Turkey. Therefore, in this multicenter trial, we aimed to assess the extent of effective anticoagulant use (by means of TTR) and epidemiological characteristics of the nonvalvular AF patients with the use of new oral anticoagulants (NOACs) in clinical practice in addition to increased awareness provided by AFTER study.\n\nAFTER-2 study is planned as a prospective, observational and multicenter study with a 6 month and 1-year follow-up of the patients. A total of 4100 patients in 42 centers reflecting the population of the twelve regions of our country according to the Nomenclature of Territorial Units for Statistics will be included in the study.\n\nThe detailed characteristics of the patients with non-valvular AF, the rates and kind of oral anticoagulant use, the effect of increased awareness and NOACs on anticoagulant use rate, TTR in warfarin using patients and the bleeding risks of the patients will be determined in this study. At the end of the study, we will question the patients in terms of major adverse events and analyze the independent predictors of these events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'nonvalvular atrial fibrillation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive adult non-valvular AF patients applied to the cardiology clinics with at least one attack of AF identified on electrocardiography without rheumatic mitral valve stenosis and prosthetic valve disease\n\nExclusion Criteria:\n\n* Patients who will refuse to be a participant or will not sign the consent form'}, 'identificationModule': {'nctId': 'NCT02354456', 'acronym': 'AFTER-2', 'briefTitle': 'Atrial Fibrillation in Turkey: Epidemiologic Registry-2', 'organization': {'class': 'OTHER', 'fullName': 'Dicle University'}, 'officialTitle': 'An Epidemiological Study to Evaluate the Use of Vitamin K Antagonists and New Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients in Turkey', 'orgStudyIdInfo': {'id': 'DicleU'}}, 'contactsLocationsModule': {'locations': [{'zip': '21280', 'city': 'Diyarbakır', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Abdulkadir Yildiz, Ass. Prof.', 'role': 'CONTACT', 'email': 'drakadiryildiz@gmail.com', 'phone': '00905052360548'}], 'facility': 'Dicle Üniversity School of Medicine', 'geoPoint': {'lat': 37.91363, 'lon': 40.21721}}], 'centralContacts': [{'name': 'Faruk Ertas, Assoc. Prof.', 'role': 'CONTACT', 'email': 'farukertas@hotmail.com', 'phone': '00904122488001', 'phoneExt': '1126'}, {'name': 'Hasan Kaya, Assoc. Prof.', 'role': 'CONTACT', 'email': 'dr_hasankaya@yahoo.com', 'phone': '00904122488001', 'phoneExt': '1120'}], 'overallOfficials': [{'name': 'Faruk Ertas, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dicle University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dicle University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Cardiology', 'investigatorFullName': 'Hasan Kaya', 'investigatorAffiliation': 'Dicle University'}}}}