Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2026-01-01 @ 4:57 PM
Study NCT ID:
NCT01084993
Status:
UNKNOWN
Last Update Posted:
2018-01-31
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding
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': 'C074619', 'term': 'bivalirudin'}, {'id': 'D006493', 'term': 'Heparin'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major bleeding and Mace', 'timeFrame': '24h post-PCI and Discharge', 'description': 'The primary end-points will be 1) the incidence of major bleeding (Replace-2 criteria) at hospital discharge and 2) the incidence of 24h post-PCI anemia (WHO criteria)'}], 'secondaryOutcomes': [{'measure': 'EFFICACY and SAFETY PARAMETERS', 'timeFrame': '30 days', 'description': 'The composite of death, MI (def 1 : Tn-t \\> 0.1 and def 2 : CK-MB \\> 30μg/l), urgent revascularization and major bleeding at 30 days post-PCI.\n\nThe incidence of ARC-defined stent thrombosis at 30 days. The incidence of access-site hematoma according to EASY scale. The incidence of radial artery occlusion at hospital discharge according to echo-doppler evaluation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary artery stenting, transradial, intracoronary'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'RATIONALE:\n\nTransradial coronary stenting is associated with less risk of access site complications and bleeding compared to femoral approach.\n\nMajor bleeding post-PCI is a strong independent predictor of mortality and MACE. Depending of the antithrombotic regimen and access-site used, bleeding related to access-site represents 50-80% of the cases. Whereas transradial approach minimizes the risks of access-site bleeding, it has no impact on non-access site bleeding.\n\nPeri-procedural anemia is also an independent predictor of mortality and MACE.\n\nWith femoral approach, bivalirudin compared to heparin ± glycoproteins IIb-IIIa has been associated with a significant reduction in access-site and non-access site related bleeding.\n\nIn a post-hoc analysis of patients treated by transradial approach in ACUITY, there was a trend for non-access site bleeding (organ bleeding) with bivalirudin compared to heparin ± glycoproteins IIb-IIIa.\n\nHYPOTHESES:\n\nIn patients at high-risk of peri-procedural bleeding, bivalirudin ± glycoproteins IIb-IIIa reduces the risk of bleeding compared to heparin ± glycoproteins IIb-IIIa.\n\nIn patients at high-risk of bleeding and undergoing transradial PCI, bivalirudin significantly reduces the incidence of non-access site bleeding and peri-procedural anemia.', 'detailedDescription': 'OBJECTIVES:\n\nThe primary objective is to compare the incidence of major bleeding and anemia 24h post-PCI in patients at high-risk of bleeding after transradial PCI with heparin or bivalirudin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least two of the following additional criteria\n* At least 70 yrs old\n* Female gender\n* Diabetes\n* Creatinine clearance \\<60mL/min\n* History of gastro-intestinal or other organ bleeding\n* Baseline anemia\n* Current treatment with glycoproteins IIb-IIIa inhibitors\n\nExclusion Criteria:\n\n* Intolerance or allergy to ASA, clopidogrel or ticlopidine precluding treatment for 12 months\n* Concurrent participation in other investigational study\n* Femoral sheath (artery)'}, 'identificationModule': {'nctId': 'NCT01084993', 'acronym': 'EASY-B2B', 'briefTitle': 'EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'EArly Discharge After Transradial Stenting of CoronarY Arteries in High-Risk Patients of Bleeding: Bivalirudin to Reduce Bleeding EASY-B2B Study', 'orgStudyIdInfo': {'id': 'EASY-B2B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bivalirudin', 'description': 'Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h', 'interventionNames': ['Drug: Bivalirudin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Heparin', 'description': '70 U/kg or standard practice', 'interventionNames': ['Drug: Heparin']}], 'interventions': [{'name': 'Bivalirudin', 'type': 'DRUG', 'otherNames': ['Angiomax'], 'description': 'Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h', 'armGroupLabels': ['Bivalirudin']}, {'name': 'Heparin', 'type': 'DRUG', 'description': '70 U/kg', 'armGroupLabels': ['Heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Michele Jadin, MSc', 'role': 'CONTACT', 'email': 'michele.jadin@crhl.ulaval.ca', 'phone': '418-6568711', 'phoneExt': '3007'}, {'name': 'Olivier F Bertrand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Quebec Heart-Lung Institute', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Olivier F Bertrand, MD, PhD', 'role': 'CONTACT', 'email': 'olivier.bertrand@criucpq.ulaval.ca', 'phone': '418-656-8711'}, {'name': 'Michele Jadin, MSc', 'role': 'CONTACT', 'email': 'michele.jadin@criucpq.ulaval.ca', 'phone': '418-656-8711', 'phoneExt': '3007'}], 'overallOfficials': [{'name': 'Olivier F Bertrand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation IUCPQ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Olivier F. Bertrand', 'investigatorAffiliation': 'Laval University'}}}}