Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-26 @ 12:52 AM
Study NCT ID:
NCT00251134
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2005-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009203', 'term': 'Myocardial Infarction'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511723', 'term': 'zodin'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000069463', 'term': 'Olive Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-11', 'studyFirstSubmitDate': '2005-11-08', 'studyFirstSubmitQcDate': '2005-11-08', 'lastUpdatePostDateStruct': {'date': '2008-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sudden cardiac death', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Total mortality', 'timeFrame': '12 months'}, {'measure': 'MACCE: Total mortality, re-infarction or stroke', 'timeFrame': '12 months'}, {'measure': 'Non-fatal resuscitation or survived direct-current (DC)-shock > 30 days', 'timeFrame': '12 months'}, {'measure': 'Total rehospitalisation', 'timeFrame': '12 months'}, {'measure': 'Revascularisation: Percutaneous transluminal coronary angioplasty (PTCA) or Coronar artery bypass grafting (CABG)', 'timeFrame': '12 months'}, {'measure': 'Detection of ventricular tachycardia or fibrillation during 12 months by an ICD, with or without ICD-intervention (shock or antitachycardia pacing).', 'timeFrame': '12 months'}, {'measure': 'Effect on the severity of depressive co-morbidity in patients surviving an acute myocardial infarction for one year: Mean BDI-II-Depression score and percentage of patients with BDI-II score ≥ 14', 'timeFrame': 'after 12 months'}, {'measure': 'Combined endpoint of Sudden Cardiac Death or adequate ICD-shock/pacing during 12 months', 'timeFrame': '12 months'}, {'measure': 'Combined endpoint of total mortality or adequate ICD-shock/pacing during 12 months', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['myocardial infarction', 'omega 3-fatty acids'], 'conditions': ['Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '17124558', 'type': 'BACKGROUND', 'citation': 'Rauch B, Schiele R, Schneider S, Gohlke H, Diller F, Gottwik M, Steinbeck G, Heer T, Katus H, Zimmer R, Erdogan A, Pfafferott C, Senges J; Omega-Study Group. Highly purified omega-3 fatty acids for secondary prevention of sudden cardiac death after myocardial infarction-aims and methods of the OMEGA-study. Cardiovasc Drugs Ther. 2006 Oct;20(5):365-75. doi: 10.1007/s10557-006-0495-6.'}, {'pmid': '24330904', 'type': 'DERIVED', 'citation': 'Zimmer R, Riemer T, Rauch B, Schneider S, Schiele R, Gohlke H, Diller F, Steinbeck G, Katus H, Senges J; OMEGA-Study Group. Effects of 1-year treatment with highly purified omega-3 fatty acids on depression after myocardial infarction: results from the OMEGA trial. J Clin Psychiatry. 2013 Nov;74(11):e1037-45. doi: 10.4088/JCP.13m08453.'}, {'pmid': '23559535', 'type': 'DERIVED', 'citation': 'Rauch B, Riemer T, Schwaab B, Schneider S, Diller F, Gohlke H, Schiele R, Katus H, Gitt A, Senges J; OMEGA study group. Short-term comprehensive cardiac rehabilitation after AMI is associated with reduced 1-year mortality: results from the OMEGA study. Eur J Prev Cardiol. 2014 Sep;21(9):1060-9. doi: 10.1177/2047487313486040. Epub 2013 Apr 4.'}, {'pmid': '21060071', 'type': 'DERIVED', 'citation': 'Rauch B, Schiele R, Schneider S, Diller F, Victor N, Gohlke H, Gottwik M, Steinbeck G, Del Castillo U, Sack R, Worth H, Katus H, Spitzer W, Sabin G, Senges J; OMEGA Study Group. OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. Circulation. 2010 Nov 23;122(21):2152-9. doi: 10.1161/CIRCULATIONAHA.110.948562. Epub 2010 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)\n* Ability to take Ω-3-FAE or olive oil without risk\n* Informed consent\n\nExclusion Criteria:\n\n* Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)\n* Known hypersensitivity to study medication\n* Dislike of fish oil\n* Haemorrhagic diathesis\n* Unwillingness to discontinue other medications containing fish oil\n* Legal incapacity\n* History of drug or alcohol abuse within 6 months\n* Any investigational therapy within one month of signing informed consent form'}, 'identificationModule': {'nctId': 'NCT00251134', 'acronym': 'OMEGA', 'briefTitle': 'OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Stiftung Institut fuer Herzinfarktforschung'}, 'officialTitle': 'OMEGA: A Prospective, Randomised, Double-Blind, Placebo-Controlled Multicentre Study in Patients Who Survived Acute Myocardial Infarction to Investigate the Efficacy and Safety of 1 Gram Ω-3-Fatty Acid Ethyl Esters (Ω-3FAE) Daily Versus Placebo to Reduce the Risk of Sudden Cardiac Death.', 'orgStudyIdInfo': {'id': 'OMEGA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'omega-3-acid ethyl ester 90', 'interventionNames': ['Drug: Zodin (drug)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'olive oil', 'interventionNames': ['Drug: Olive oil (placebo)']}], 'interventions': [{'name': 'Zodin (drug)', 'type': 'DRUG', 'description': '1 gram omega-3-acid ethyl esters 90 daily for a period of 12 months', 'armGroupLabels': ['1']}, {'name': 'Olive oil (placebo)', 'type': 'DRUG', 'description': '1 gram olive oil daily for a period of 12 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67063', 'city': 'Ludwigshafen am Rhein', 'state': 'Rhineland-Palatinate', 'country': 'Germany', 'facility': 'Klinikum der Stadt Ludwigshafen gGmbH', 'geoPoint': {'lat': 49.48121, 'lon': 8.44641}}, {'zip': '47228', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Johanniter-Krankenhaus Rheinhausen', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '45138', 'city': 'Essen', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '65929', 'city': 'Frankfurt am Main', 'country': 'Germany', 'facility': 'Staedt. Kliniken Frankfurt/Main-Hoechst', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '90766', 'city': 'Fürth', 'country': 'Germany', 'facility': 'Klinikum Fuerth', 'geoPoint': {'lat': 49.42335, 'lon': 7.23919}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '85049', 'city': 'Ingolstadt', 'country': 'Germany', 'facility': 'Klinikum Ingolstadt', 'geoPoint': {'lat': 48.76508, 'lon': 11.42372}}, {'zip': '91413', 'city': 'Neustadt/Aisch', 'country': 'Germany', 'facility': 'Klinikum Neustadt'}, {'zip': '45661', 'city': 'Recklinghausen', 'country': 'Germany', 'facility': 'Elisabeth-Krankenhaus', 'geoPoint': {'lat': 51.61379, 'lon': 7.19738}}, {'zip': '59494', 'city': 'Soest', 'country': 'Germany', 'facility': 'Marienkrankenhaus', 'geoPoint': {'lat': 51.57558, 'lon': 8.10619}}], 'overallOfficials': [{'name': 'Jochen Senges, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stiftung Institut fuer Herzinfarktforschung, Chairman'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stiftung Institut fuer Herzinfarktforschung', 'class': 'OTHER'}, 'collaborators': [{'name': 'Trommsdorff GmbH & Co. KG', 'class': 'INDUSTRY'}, {'name': 'Pronova BioPharma', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Dr. Jochen Senges', 'oldOrganization': 'Stiftung Institut für Herzinfarktforschung, 67063 Ludwigshafen, Germany'}}}}