Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT01402427
Status:
COMPLETED
Last Update Posted:
2014-06-02
First Post:
2011-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Is Verapamil In TransRadial Interventions OmittabLe?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014700', 'term': 'Verapamil'}], 'ancestors': [{'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ihizoh@web.de', 'phone': '+36 1 4651800', 'title': 'Istvan Hizoh, MD, PhD / Senior Consultant', 'phoneExt': '71773', 'organization': 'State Health Center, Hungary'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The trial was conducted in a single, high-volume institution by experienced operators. The results may not be applicable to lower-volume centers or to operators with less experience.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.', 'otherNumAtRisk': 297, 'otherNumAffected': 0, 'seriousNumAtRisk': 297, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.', 'otherNumAtRisk': 294, 'otherNumAffected': 0, 'seriousNumAtRisk': 294, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Access Site Conversions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-0.011', 'ciUpperLimit': '0.033', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Code Breaks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.', 'description': 'Code break: a composite of access site conversion and unplanned use of vasodilators.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Vasodilator Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '297', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Procedural Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '31.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '30.0'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Fluoroscopic Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '10.7'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '9.6'}]}]}], 'analyses': [{'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Contrast Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '156.5'}, {'value': '72.5', 'groupId': 'OG001', 'lowerLimit': '48.0', 'upperLimit': '146.0'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.', 'unitOfMeasure': 'milliliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Subjective Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'OG000'}, {'value': '294', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.45', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.', 'description': 'Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '294'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '297'}, {'groupId': 'FG001', 'numSubjects': '294'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '591', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Verapamil', 'description': 'Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo: Intraarterial administration of 10 mL saline.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '62.5', 'spread': '10.8', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '10.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '190', 'groupId': 'BG001'}, {'value': '376', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hungary', 'categories': [{'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '294', 'groupId': 'BG001'}, {'value': '591', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 591}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2011-07-21', 'resultsFirstSubmitDate': '2014-04-17', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-30', 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Access Site Conversions', 'timeFrame': 'Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.'}], 'secondaryOutcomes': [{'measure': 'Rate of Code Breaks', 'timeFrame': 'Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.', 'description': 'Code break: a composite of access site conversion and unplanned use of vasodilators.'}, {'measure': 'Rate of Vasodilator Use', 'timeFrame': 'Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.'}, {'measure': 'Procedural Time', 'timeFrame': 'Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.'}, {'measure': 'Fluoroscopic Time', 'timeFrame': 'Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.'}, {'measure': 'Contrast Volume', 'timeFrame': 'The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.'}, {'measure': 'Subjective Pain', 'timeFrame': 'Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.', 'description': 'Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Coronary Angiography', 'Percutaneous Coronary Intervention', 'Transradial', 'Radial Artery Spasm', 'Verapamil', 'Adverse Effects'], 'conditions': ['Coronary Disease', 'Verapamil Toxicity']}, 'referencesModule': {'references': [{'pmid': '24732918', 'type': 'RESULT', 'citation': 'Hizoh I, Majoros Z, Major L, Gulyas Z, Szabo G, Kerecsen G, Korda A, Molnar F, Kiss RG. Need for prophylactic application of verapamil in transradial coronary procedures: a randomized trial. The VITRIOL (is Verapamil In TransRadial Interventions OmittabLe?) trial. J Am Heart Assoc. 2014 Apr 14;3(2):e000588. doi: 10.1161/JAHA.113.000588.'}]}, 'descriptionModule': {'briefSummary': 'Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings.\n\nMethods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing transradial coronary angiography and/or percutaneous coronary intervention\n* successful cannulation of the radial artery\n\nExclusion Criteria:\n\n* reduced left ventricular systolic function (LVEF\\<35%)\n* significant aortic stenosis\n* bradycardia (\\<50/min.)\n* myocardial infarction complicated by cardiogenic shock and/or high grade AV block'}, 'identificationModule': {'nctId': 'NCT01402427', 'acronym': 'VITRIOL', 'briefTitle': 'Is Verapamil In TransRadial Interventions OmittabLe?', 'organization': {'class': 'OTHER', 'fullName': 'State Health Center, Hungary'}, 'officialTitle': 'Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions', 'orgStudyIdInfo': {'id': 'SHCCARD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verapamil', 'interventionNames': ['Drug: Verapamil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Verapamil', 'type': 'DRUG', 'description': 'Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.', 'armGroupLabels': ['Verapamil']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Intraarterial administration of 10 mL saline.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1134', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'State Health Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Istvan Hizoh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'State Health Center, Budapest, Hungary'}, {'name': 'Robert Gabor Kiss, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'State Health Center, Budapest, Hungary'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Health Center, Hungary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Istvan Hizoh, MD, PhD', 'investigatorAffiliation': 'State Health Center, Hungary'}}}}