Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT03605433
Status:
UNKNOWN
Last Update Posted:
2018-07-30
First Post:
2018-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-22', 'studyFirstSubmitDate': '2018-07-22', 'studyFirstSubmitQcDate': '2018-07-22', 'lastUpdatePostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '5 years', 'description': 'Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death'}, {'measure': 'Graft Patency', 'timeFrame': '5 years', 'description': 'Time from randomization to the first occurence of saphenous graft oclusion'}, {'measure': 'Major Bleeding', 'timeFrame': '5 years', 'description': 'Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis)'}], 'secondaryOutcomes': [{'measure': 'MACE, cardiovascular death', 'timeFrame': '5 years', 'description': 'Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia'}, {'measure': 'All-cause mortality', 'timeFrame': '5 years', 'description': 'Time from randomization to first occurrence of all-cause mortality'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Saphenous Vein Graft Patency']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate whether treatment with oral anticoagulation or oral anticoagulation and aspirin is better than aspirin alone in cardiovascular outcomes and saphenous graft patency in patients submitted to coronary artery bypass graft.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients referred to coronary artery bypass graft and at least one saphenous vein graft\n\nExclusion Criteria:\n\n* Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy\n* Stroke within 1 month or any history of hemorrhagic or lacunar stroke\n* Estimated glomerular filtration rate (eGFR)\\<15 mL/min'}, 'identificationModule': {'nctId': 'NCT03605433', 'acronym': 'SCOOP', 'briefTitle': 'Surgical Revascularization Outcomes After Oral Anticoagulation or Antiplatelets', 'organization': {'class': 'OTHER', 'fullName': 'Unidade Local de Saúde de Coimbra, EPE'}, 'officialTitle': 'Surgical Coronary Revascularization Outcomes After Oral Anticoagulation or Antiplatelet Strategies', 'orgStudyIdInfo': {'id': 'SCOOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral Anticoagulation+Antiplatelet', 'description': 'Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily.', 'interventionNames': ['Drug: Rivaroxaban']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Anticoagulation', 'description': 'Rivaroxaban 20 mg once daily', 'interventionNames': ['Drug: Rivaroxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antiplatet', 'description': 'Aspirin 100 mg once daily', 'interventionNames': ['Drug: Rivaroxaban']}], 'interventions': [{'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation', 'armGroupLabels': ['Antiplatet', 'Oral Anticoagulation', 'Oral Anticoagulation+Antiplatelet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Coimbra', 'country': 'Portugal', 'facility': 'Centro Hospitalar e Universitário de Coimbra', 'geoPoint': {'lat': 40.20686, 'lon': -8.41996}}], 'centralContacts': [{'name': 'Luis Paiva, MD', 'role': 'CONTACT', 'email': 'luisvpaiva@gmail.com', 'phone': '+351917952197'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unidade Local de Saúde de Coimbra, EPE', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Luis Paiva', 'investigatorFullName': 'Luís Paiva', 'investigatorAffiliation': 'Unidade Local de Saúde de Coimbra, EPE'}}}}