Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-30 @ 10:39 PM
Study NCT ID:
NCT05744804
Status:
UNKNOWN
Last Update Posted:
2023-02-27
First Post:
2023-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-07-19', 'releaseDate': '2024-02-06'}], 'estimatedResultsFirstSubmitDate': '2024-02-06'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011725', 'term': 'Pyridines'}, {'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-16', 'studyFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major adverse cardiovascular event', 'timeFrame': '10 months', 'description': 'Major adverse cardiovascular event'}, {'measure': 'Left ventricular function', 'timeFrame': '10 months', 'description': 'Left ventricular function'}, {'measure': 'Left ventricular thrombus', 'timeFrame': '10 months', 'description': 'Left ventricular thrombus'}, {'measure': 'Transient Ischemic Attacks or cerebrovascular stroke', 'timeFrame': '10 months', 'description': 'Transient Ischemic Attacks or cerebrovascular stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Patient With Anterior Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '20805624', 'type': 'BACKGROUND', 'citation': "Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Rother J, Smith SC Jr, Salette G, Contant CF, Massaro JM, Steg PG; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi: 10.1001/jama.2010.1322. Epub 2010 Aug 30."}, {'pmid': '8026047', 'type': 'BACKGROUND', 'citation': 'Merlini PA, Bauer KA, Oltrona L, Ardissino D, Cattaneo M, Belli C, Mannucci PM, Rosenberg RD. Persistent activation of coagulation mechanism in unstable angina and myocardial infarction. Circulation. 1994 Jul;90(1):61-8. doi: 10.1161/01.cir.90.1.61.'}, {'pmid': '20118566', 'type': 'BACKGROUND', 'citation': 'Ueda Y, Ogasawara N, Matsuo K, Hirotani S, Kashiwase K, Hirata A, Nishio M, Nemoto T, Wada M, Masumura Y, Kashiyama T, Konishi S, Nakanishi H, Kobayashi Y, Akazawa Y, Kodama K. Acute coronary syndrome: insight from angioscopy. Circ J. 2010 Mar;74(3):411-7. doi: 10.1253/circj.cj-09-0795. Epub 2010 Jan 30.'}, {'pmid': '19228706', 'type': 'BACKGROUND', 'citation': "Borissoff JI, Spronk HM, Heeneman S, ten Cate H. Is thrombin a key player in the 'coagulation-atherogenesis' maze? Cardiovasc Res. 2009 Jun 1;82(3):392-403. doi: 10.1093/cvr/cvp066. Epub 2009 Feb 19."}]}, 'descriptionModule': {'briefSummary': 'Despite the use of guideline directed optimal medical therapy, 12% of patients with stable coronary heart disease and 18% of patients with recent acute coronary syndrome experience recurrent major adverse cardiovascular events 1. The risk of recurrent cardiovascular events may be related to persistent elevation of thrombin beyond the index event 2,3\n\nwhich leads to progression of cardiovascular disease by inducing inflammation, endothelial dysfunction and thrombosis 4. In patients with coronary heart disease, vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) have been explored as secondary prevention strategies and have shown cardiovascular benefits at the cost of higher bleeding events 5,6,7,8.\n\nhoweverLeft ventricular thrombus (LVT) usually appearswithin 1 month after ST-segment elevation myocardial infarction (STEMI) and mostlyforms after anterior STEMI.9,11Although the prevalenceof LVT after acute myocardial infarction hasdecreased dramatically in modern times due to the progress of reperfusion therapy, LVT incidence in patients with anterior STEMI remains at 4% to 26%.10,12 It complicates acute myocardial infarction and is associated with a higher incidence of poor outcomes.9'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel\n\nExclusion Criteria:\n\n1. Patients with liver cirrhosis.\n2. Patients with severe mitral stenosis .\n3. Patients with bleeding tendency (HASBLED score ≥ 3)\n4. Severe renal impairment ( creatinine clearance \\< 30 ml/min ).\n5. patients with prosthetic valve .\n6. patients on ticagrelor treatment\n7. patients with Atrial Fibrillation'}, 'identificationModule': {'nctId': 'NCT05744804', 'briefTitle': 'Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction', 'orgStudyIdInfo': {'id': 'soh-Med-23-01-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '-group of patients(75 patients) will receive low dose rivaroxaban', 'description': '-group of patients(75 patients) will receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and cloppe', 'interventionNames': ['Drug: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group of patients:', 'description': 'control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only', 'interventionNames': ['Drug: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)']}], 'interventions': [{'name': '-group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg', 'type': 'DRUG', 'description': 'receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally)', 'armGroupLabels': ['-group of patients(75 patients) will receive low dose rivaroxaban']}, {'name': '(acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)', 'type': 'DRUG', 'description': 'control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only', 'armGroupLabels': ['control group of patients:']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'contacts': [{'name': 'Magdy m Amin, professor', 'role': 'CONTACT'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed A Saber, resident', 'role': 'CONTACT', 'email': 'mohamedelameer@med.sohag.edu.eg', 'phone': '01150989566'}, {'name': 'Sharaf Eldin S Abdallah, professor', 'role': 'CONTACT', 'phone': '01122789999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at internal medecine department', 'investigatorFullName': 'Mohamed Elamir Saber', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-02-06', 'type': 'RELEASE'}, {'date': '2024-07-19', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohamed Elamir Saber, resident doctor at internal medecine department, Sohag University'}}}}