Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-03-06 @ 12:30 PM
Study NCT ID:
NCT00616460
Status:
COMPLETED
Last Update Posted:
2015-06-12
First Post:
2008-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006402', 'term': 'Hematologic Diseases'}], 'ancestors': [{'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C074619', 'term': 'bivalirudin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-11', 'studyFirstSubmitDate': '2008-02-05', 'studyFirstSubmitQcDate': '2008-02-14', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'End points: Primary :Major & minor bleeding Port of entry related complications', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'End points: Secondary: 30 days MACE', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['safety', 'efficacy'], 'conditions': ['Hematologic Diseases']}, 'descriptionModule': {'briefSummary': 'To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of dual antiplatelet therapy in patients with high tendency for bleeding during urgent and elective PCI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion criteria (any of the following):\n\n* ≥75 years\n* Creatinin clearance rate \\< 60 ml per minute\n* Anemia (Hb 9-11 mg%)\n* Hypertension: BP \\> 180/95 mmHg but less than 210/110 m Hg\n* Diabetic Pts\n* Steroid treated Pts\n* Recent (within 6 weeks) non major surgery\n* Pts with hematological disorders associated with tendency for bleeding like Thrombocytopenia (platelets 50000-150000) included TTP;\n\nExclusion Criteria:\n\nExclusion criteria:\n\n* Age \\< 18 year\n* Acute STEMI (Primary PCI)\\*\n* Rescue angioplasty \\<12h after lytic therapy\\*\n* Active bleeding\n* S.C LMWH \\< 8 hours or UFH \\< 4 hours before PCI\n* Using IIb /IIIa as an upstream therapy before PCI\n* PCI which will be involved with obligatory IIb /IIIa therapy:\n\n(thrombotic complication, occlusive dissection)\n\n* INR\\>1.5 on day of cathetrization\n* Bolus of 600mg of Clopidogrel before PCI\n* Current pregnancy or women in reproductive age without contraceptives\n* Hypersensitivity to heparin or bivalirudin or its components \\*(possible using IIB/IIIA)'}, 'identificationModule': {'nctId': 'NCT00616460', 'acronym': 'ACRIPAB', 'briefTitle': 'ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'orgStudyIdInfo': {'id': '0124-07-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bivalirudin', 'interventionNames': ['Drug: Bivalirudin']}], 'interventions': [{'name': 'Bivalirudin', 'type': 'DRUG', 'description': 'Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT \\< 250', 'armGroupLabels': ['Bivalirudin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Heart Institute haEmek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Yoav Turgeman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heart Institute HaEmek medical center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Cardiology Department', 'investigatorFullName': 'Turgeman Yoav', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}