Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT01955759
Status:
UNKNOWN
Last Update Posted:
2013-12-17
First Post:
2013-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atrial Fibrillation and By-pass Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000638', 'term': 'Amiodarone'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D017298', 'term': 'Bisoprolol'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-15', 'studyFirstSubmitDate': '2013-09-21', 'studyFirstSubmitQcDate': '2013-09-29', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'atrial fibrillation', 'timeFrame': '10 days on average during hospital stay after coronary by-pass surgery', 'description': 'outcome will be number of patients free from atrial fibrillation.'}]}, 'conditionsModule': {'conditions': ['Patients With Coronary Artery Disease Scheduled for by Pass Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* significant coronary disease, sinus rhythm\n\nExclusion Criteria:\n\n* valvular disease, former by-pass surgery'}, 'identificationModule': {'nctId': 'NCT01955759', 'briefTitle': 'Atrial Fibrillation and By-pass Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Heart Center BH Tuzla'}, 'officialTitle': 'Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery', 'orgStudyIdInfo': {'id': '0115/09 - (2013)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'beta blocker and amiodarone', 'description': 'The inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge', 'interventionNames': ['Drug: Amiodarone tab 200 mg x 3', 'Drug: beta blockers Bisoprolol in adjusted dose']}, {'type': 'EXPERIMENTAL', 'label': 'beta blocker and statin', 'description': 'The intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge.', 'interventionNames': ['Drug: rosuvastatin 20 mg tab x1', 'Drug: beta blockers Bisoprolol in adjusted dose']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'beta blocker', 'description': 'Patients will receive beta blocker (Bisoprolol tab in adjusted dose).', 'interventionNames': ['Drug: beta blockers Bisoprolol in adjusted dose']}], 'interventions': [{'name': 'Amiodarone tab 200 mg x 3', 'type': 'DRUG', 'otherNames': ['cordarone'], 'description': 'starting 7 days before coronary by-pass surgery per os 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge', 'armGroupLabels': ['beta blocker and amiodarone']}, {'name': 'rosuvastatin 20 mg tab x1', 'type': 'DRUG', 'otherNames': ['crestor'], 'description': 'starting 7 days before coronary by-pass surgery', 'armGroupLabels': ['beta blocker and statin']}, {'name': 'beta blockers Bisoprolol in adjusted dose', 'type': 'DRUG', 'otherNames': ['zebeta'], 'description': 'starting 7 days befoe coronary by-pass surgery', 'armGroupLabels': ['beta blocker', 'beta blocker and amiodarone', 'beta blocker and statin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75000', 'city': 'Tuzla', 'state': 'TK', 'country': 'Bosnia and Herzegovina', 'contacts': [{'name': 'Enes Osmanović', 'role': 'CONTACT', 'email': 'osmanovic@bih.net.ba', 'phone': '+387 66 725 744'}], 'facility': 'Heart Center BH', 'geoPoint': {'lat': 44.53842, 'lon': 18.66709}}], 'centralContacts': [{'name': "Enes Osmanovic, Master's degree", 'role': 'CONTACT', 'email': 'osmanovic@bhsrce.ba', 'phone': '+387 66 725 744'}, {'name': 'Goran Imamovic', 'role': 'CONTACT', 'email': 'goran.imamovic@fmc-ag.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heart Center BH Tuzla', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr.med.sc.Dr Enes Osmanovic', 'investigatorFullName': 'Enes Osmanović', 'investigatorAffiliation': 'Heart Center BH Tuzla'}}}}