Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-28 @ 10:56 PM
Study NCT ID:
NCT05975320
Status:
UNKNOWN
Last Update Posted:
2023-08-03
First Post:
2023-07-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-12-05', 'releaseDate': '2024-10-20'}], 'estimatedResultsFirstSubmitDate': '2024-10-20'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}, {'id': 'C522181', 'term': 'apixaban'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-27', 'studyFirstSubmitDate': '2023-07-27', 'studyFirstSubmitQcDate': '2023-07-27', 'lastUpdatePostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of bleeding events using both (HAS-BLED) & (ORBIT) SCORES', 'timeFrame': '6 months', 'description': 'Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \\& (ORBIT) SCORES will be calculated and compared for all cases .'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patients With Atrial Fibrillation Receiving Oral Anticoagulants']}, 'referencesModule': {'references': [{'pmid': '21982650', 'type': 'BACKGROUND', 'citation': 'Piccini JP, Fraulo ES, Ansell JE, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Kong MH, Lopes RD, Mills RM, Peterson ED. Outcomes registry for better informed treatment of atrial fibrillation: rationale and design of ORBIT-AF. Am Heart J. 2011 Oct;162(4):606-612.e1. doi: 10.1016/j.ahj.2011.07.001.'}, {'pmid': '20299623', 'type': 'BACKGROUND', 'citation': 'Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18.'}, {'pmid': '24226379', 'type': 'BACKGROUND', 'citation': 'De Caterina R, Husted S, Wallentin L, Andreotti F, Arnesen H, Bachmann F, Baigent C, Huber K, Jespersen J, Kristensen SD, Lip GY, Morais J, Rasmussen LH, Siegbahn A, Verheugt FW, Weitz JI. Vitamin K antagonists in heart disease: current status and perspectives (Section III). Position paper of the ESC Working Group on Thrombosis--Task Force on Anticoagulants in Heart Disease. Thromb Haemost. 2013 Dec;110(6):1087-107. doi: 10.1160/TH13-06-0443. Epub 2013 Nov 14.'}, {'pmid': '26424865', 'type': 'BACKGROUND', 'citation': "O'Brien EC, Simon DN, Thomas LE, Hylek EM, Gersh BJ, Ansell JE, Kowey PR, Mahaffey KW, Chang P, Fonarow GC, Pencina MJ, Piccini JP, Peterson ED. The ORBIT bleeding score: a simple bedside score to assess bleeding risk in atrial fibrillation. Eur Heart J. 2015 Dec 7;36(46):3258-64. doi: 10.1093/eurheartj/ehv476. Epub 2015 Sep 29."}]}, 'descriptionModule': {'briefSummary': "Atrial fibrillation (AF) is type of arrhythmia characterized by an irregular and often rapid heartbeats, it has strong associations with other cardiovascular diseases, such as heart failure, coronary artery disease (CAD), valvular heart disease, diabetes mellitus, thyrotoxicosis and hypertension.\n\nAtrial fibrillation is the most frequent cardiac arrhythmia. It has been estimated that 6-12 million people worldwide will suffer this condition in the US by 2050 and 17.9 million people in Europe by 2060. Atrial fibrillation is a major risk factor for ischemic stroke and provokes important economic burden along with significant morbidity and mortality .\n\n(AF) is arrhythmia with the potential to cause thromboembolism. Studies suggest that AF increases the risk of stroke five-folds. Stroke prevention is central to the management of patients with atrial fibrillation (AF), and effective stroke prevention requires oral anticoagulation (OAC). Either a vitamin K antagonist (VKA; e.g. warfarin) or a non-VKA oral anticoagulant (NOAC) .\n\nIt's essential reach the balance between prevention of thromboembolic as well as bleeding events during the anticoagulant use."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '-All patients with atrial fibrillation :\n\n1. Aged 18 years old or older .\n2. Underwent cardiac valve replacement\n3. Who have valvular heart disease receiving anticoagulants .\n4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.\n5. Receiving either vitamin K antagonist e.g warfarin or NOAC .', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with atrial fibrillation :\n\n 1. Aged 18 years old or older .\n 2. Underwent cardiac valve replacement\n 3. Who have valvular heart disease receiving anticoagulants .\n 4. Who have non valvular AF in whom CHA2DS 2VASc score 2 or more.\n 5. Receiving either vitamin K antagonist e.g warfarin or NOAC .\n\nExclusion Criteria:\n\n1. Patients age less than 18 years old\n2. Patients receiving anticoagulants without atrial fibrillations\n3. Pregnant patients with AF\n4. Patients with AF on Non oral anticoagulants'}, 'identificationModule': {'nctId': 'NCT05975320', 'briefTitle': '"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': '"ORBIT" Versus "HAS-BLED" Scores in Predicting Major Bleeding in Patients With Atrial Fibrillation Receiving Oral Anticoagulants.', 'orgStudyIdInfo': {'id': 'Soh-med-23-07-03MS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['apixaban, Rivarospire'], 'description': 'Patients receiving oral anticoagulants will be followed up for 6 months to detect occurrence of any major bleeding events include (spontaneous epistaxis , spontaneous bleeding per gums , hematemesis , bleeding per rectum , intracranial hemorrhage and internal hemorrhage ). Then, incidence of bleeding events using both (HAS-BLED) \\& (ORBIT) SCORES will be calculated and compared for all cases .'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yasmeen M Al-anwer, Resident', 'role': 'CONTACT', 'email': 'yassminmohamed@med.sohag.edu.eg', 'phone': '01152631299'}, {'name': 'lotfy H Abo Dahab, Professor', 'role': 'CONTACT', 'phone': '01003459739'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident of internal medicine department, Sohag university hospital', 'investigatorFullName': 'Yasmin Mohamed Mohamed', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-10-20', 'type': 'RELEASE'}, {'date': '2024-12-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Yasmin Mohamed Mohamed, resident of internal medicine department, Sohag university hospital, Sohag University'}}}}