Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT02448550
Status:
TERMINATED
Last Update Posted:
2018-05-24
First Post:
2015-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2016-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-23', 'studyFirstSubmitDate': '2015-05-15', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Net adverse clinical events (composite of efficacy and safety [bleeding] endpoints)', 'timeFrame': '30-days'}], 'secondaryOutcomes': [{'measure': 'all cause mortality, myocardial infarction, or unplanned revascularization for ischemia', 'timeFrame': '30-days'}, {'measure': 'Bleeding Academic Research Consortium grade III or V bleeding events', 'timeFrame': '30-days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Percutaneous Coronary Intervention']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to determine whether bivalirudin is non-inferior to unfractionated heparin in patients with stable angina, unstable angina, or non-ST segment elevation myocardial infarction undergoing percutaneous coronary intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Undergoing PCI for stable angina, unstable angina, or non-ST segment elevation myocardial infarction.\n2. Age 18 years or older.\n\nExclusion Criteria:\n\n1. Inability to obtain consent\n2. Emergency cardiac catheterization for ST-segment elevation myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT02448550', 'acronym': 'CALIFORNIA', 'briefTitle': 'Comparison of Anticoagulation for All-comers Undergoing Percutaneous Coronary Revascularization Trial', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Comparison of Unfractionated Heparin and Bivalirudin for Percutaneous Coronary Intervention for Stable Angina, Unstable Angina, and Non-ST Segment Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'KP-RRC-CE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bivalirudin', 'description': 'Bivalirudin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.', 'interventionNames': ['Drug: Bivalirudin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'unfractionated heparin', 'description': 'Unfractionated heparin will be used for PCI with bailout glycoprotein 2b3a inhibitor use permitted.', 'interventionNames': ['Drug: Unfractionated heparin']}], 'interventions': [{'name': 'Bivalirudin', 'type': 'DRUG', 'armGroupLabels': ['bivalirudin']}, {'name': 'Unfractionated heparin', 'type': 'DRUG', 'armGroupLabels': ['unfractionated heparin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}