{ "FullStudy":{ "Rank":217582, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519518", "OrgStudyIdInfo":{ "OrgStudyId":"923" }, "Organization":{ "OrgFullName":"Liverpool Heart and Chest Hospital NHS Foundation Trust", "OrgClass":"OTHER" }, "BriefTitle":"How Effective Are Antithrombotic Therapies in Primary Percutaneous Coronary Intervention", "OfficialTitle":"A Randomised Controlled Trial to Compare Unfractionated Heparin Versus Bivalirudin in the Treatment of Patients With a Clinical Diagnosis of ST-Segment Elevation Myocardial Infarction Events - For Planned Management With Primary PCI", "Acronym":"HEAT-PPCI" }, "StatusModule":{ "StatusVerifiedDate":"April 2015", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"April 7, 2015", "ResultsFirstSubmitQCDate":"April 7, 2015", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 22, 2015", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 24, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 13, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Dr Rod Stables", "ResponsiblePartyInvestigatorTitle":"Consultant Cardiologist", "ResponsiblePartyInvestigatorAffiliation":"Liverpool Heart and Chest Hospital NHS Foundation Trust" }, "LeadSponsor":{ "LeadSponsorName":"Liverpool Heart and Chest Hospital NHS Foundation Trust", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to compare unfractionated heparin (UFH) and bivalirudin in the performance and subsequent outcomes of Primary percutaneous coronary intervention. This will be a pragmatic trial. Interventional procedures will be performed to reflect current and evolving standards, including predominant radial access. All patients will be treated with routine oral anti-platelet therapy pre-procedure. GP IIb/IIIa inhibitors will be reserved for 'bail out' treatment only.", "DetailedDescription":"HEAT-PPCI is a single-centre prospective, dual-arm, open-label, randomised controlled trial comparing two antithrombotic agents in patients undergoing PPCI. All patients presenting to the PPCI service at Liverpool Heart and Chest Hospital will be assessed for trial eligibility. The patients will be allocated by randomisation in equal proportions to the two treatment groups receiving UFH (70 units/kg prior to the procedure) or bivalirudin (bolus of 0.75 mg/kg prior to the start of the intervention, followed by an infusion of 1.75 mg/kg per hour for the duration of the procedure).\n\nPre-Specified Subgroup Analyses\n\nSubgroup analyses looking at the impact of access site comparing radial versus femoral route\nAssessment of the outcomes in diabetic patients receiving oral hypoglycaemic or insulin therapy versus all other patients\nComparing the outcomes in patients < or ≥ 75 years of age\nType of p2y12 receptor inhibiting antiplatelet agent (Examples: clopidogrel, prasugrel, ticagrelor)\nPatients with impaired LV function versus normal LV function\nPatients managed with actual or attempted primary PCI versus no immediate PCI procedure attempted\n\nPLATELET FUNCTION SUBSTUDY A substudy will be performed to assess indices of coagulation and platelet function studies comparing the impact of heparin or bivalirudin therapy on coagulation status at the end of the PPCI procedure. This study will be performed on all patients treated between the hours of 0800 and 1600, Monday to Friday. A single blood sample taken at the time of general blood sampling for routine clinical screening will be analysed." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Acute ST Elevation Myocardial Infarction" ] }, "KeywordList":{ "Keyword":[ "ST elevation myocardial infarction", "Primary percutaneous coronary intervention", "Unfractionated heparin", "Bivalirudin", "primary angioplasty" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"1829", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Unfractionated heparin", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"70 units/kg body weight intravenous", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: unfractionated heparin" ] } },{ "ArmGroupLabel":"bivalirudin", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Bivalirudin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"unfractionated heparin", "InterventionDescription":"70 units/kg body weight intravenous", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Unfractionated heparin" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "UFH" ] } },{ "InterventionType":"Drug", "InterventionName":"Bivalirudin", "InterventionDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "bivalirudin" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Angiox" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization", "PrimaryOutcomeTimeFrame":"28 days" },{ "PrimaryOutcomeMeasure":"Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition", "PrimaryOutcomeTimeFrame":"28 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure", "SecondaryOutcomeTimeFrame":"28 days" },{ "SecondaryOutcomeMeasure":"Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition", "SecondaryOutcomeTimeFrame":"28 days" },{ "SecondaryOutcomeMeasure":"Stent Thrombosis Rate (ARC Definite or Probable)", "SecondaryOutcomeTimeFrame":"28 days" },{ "SecondaryOutcomeMeasure":"For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes", "SecondaryOutcomeTimeFrame":"28 days" },{ "SecondaryOutcomeMeasure":"All Cause Mortality", "SecondaryOutcomeTimeFrame":"1 year" },{ "SecondaryOutcomeMeasure":"Development of Thrombocytopenia", "SecondaryOutcomeTimeFrame":"28 days" },{ "SecondaryOutcomeMeasure":"Door-to-first Device Time", "SecondaryOutcomeTimeFrame":"28 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nAll patients presenting with a suspected myocardial infarction event with PPCI as the proposed index reperfusion strategy will be included in the trial\n\nExclusion Criteria:\n\n≤ 18 years of age\nKnown intolerance, hypersensitivity or contraindication to any trial medication\nActive bleeding at presentation\nArtificial ventilation, reduced conscious level or other factors precluding the administration of oral antiplatelet therapy\nPrevious enrolment in this trial", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Rod Stables, MA DM FRCP", "OverallOfficialAffiliation":"Liverpool Heart and Chest Hospital, Liverpool, UK", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Liverpool Heart and Chest Hospital", "LocationCity":"Liverpool", "LocationState":"Merseyside", "LocationZip":"L14 3PE", "LocationCountry":"United Kingdom" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25002178", "ReferenceType":"derived", "ReferenceCitation":"Shahzad A, Kemp I, Mars C, Wilson K, Roome C, Cooper R, Andron M, Appleby C, Fisher M, Khand A, Kunadian B, Mills JD, Morris JL, Morrison WL, Munir S, Palmer ND, Perry RA, Ramsdale DR, Velavan P, Stables RH; HEAT-PPCI trial investigators. Unfractionated heparin versus bivalirudin in primary percutaneous coronary intervention (HEAT-PPCI): an open-label, single centre, randomised controlled trial. Lancet. 2014 Nov 22;384(9957):1849-1858. doi: 10.1016/S0140-6736(14)60924-7. Epub 2014 Jul 4. Erratum in: Lancet. 2014 Nov 22;384(9957):1848." },{ "ReferencePMID":"24219045", "ReferenceType":"derived", "ReferenceCitation":"Malik N, Gershlick AH. The clinical and economic impact of bivalirudin for percutaneous coronary intervention. Expert Rev Pharmacoecon Outcomes Res. 2013 Dec;13(6):699-706. doi: 10.1586/14737167.2013.844650. Review." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Unfractionated Heparin", "FlowGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Bivalirudin", "FlowGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"914" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"915" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"907" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"905" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"7" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"10" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Consent not available", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"10" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Unfractionated Heparin", "BaselineGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Bivalirudin", "BaselineGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"907" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"905" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"1812" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Inter-Quartile Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"63.6", "BaselineMeasurementLowerLimit":"54.0", "BaselineMeasurementUpperLimit":"73.8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"62.9", "BaselineMeasurementLowerLimit":"53.7", "BaselineMeasurementUpperLimit":"74" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"63.2", "BaselineMeasurementLowerLimit":"53.9", "BaselineMeasurementUpperLimit":"73.9" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"244" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"258" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"502" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"663" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"647" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1310" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Major Adverse Cardiac Events (MACE) in Terms of the Incidence of All Cause Mortality, Cerebrovascular Accident, Re-infarction and Additional Unplanned Target Lesion Revascularization", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of total participants", "OutcomeMeasureTimeFrame":"28 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Unfractionated Heparin", "OutcomeGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Bivalirudin", "OutcomeGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"907" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"905" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.7" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.7" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Type 3-5 Bleeding According to BARC (Bleeding Academic Research Consortium)Definition", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of total participants", "OutcomeMeasureTimeFrame":"28 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Unfractionated Heparin", "OutcomeGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Bivalirudin", "OutcomeGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"907" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"905" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"CKMB Release Following Index Revascularisation Measured With a Single Estimation 12-18 Hours After the Procedure", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"28 days" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Minor Bleeding: Type 2 Bleeding According to BARC (Bleeding Academic Research Consortium) Definition", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of total participants", "OutcomeMeasureTimeFrame":"28 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Unfractionated Heparin", "OutcomeGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Bivalirudin", "OutcomeGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"907" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"905" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9.2" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Stent Thrombosis Rate (ARC Definite or Probable)", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of total participants", "OutcomeMeasureTimeFrame":"28 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Unfractionated Heparin", "OutcomeGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Bivalirudin", "OutcomeGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"907" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"905" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3.4" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"For Illustration, and to Allow Comparison With Existing Trials the Rate of Net Adverse Clinical Events (NACE), Combining the Primary Safety and Efficacy Outcomes", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"28 days" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"All Cause Mortality", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"1 year" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Development of Thrombocytopenia", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"28 days" },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Door-to-first Device Time", "OutcomeMeasureReportingStatus":"Not Posted", "OutcomeMeasureTimeFrame":"28 days" } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Unfractionated Heparin", "EventGroupDescription":"70 units/kg body weight intravenous\n\nunfractionated heparin: 70 units/kg body weight intravenous", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" },{ "EventGroupId":"EG001", "EventGroupTitle":"Bivalirudin", "EventGroupDescription":"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour\n\nBivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"0", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dr Rod Stables", "PointOfContactOrganization":"Liverpool Heart and Chest Hospital", "PointOfContactEMail":"rod.stables@lhch.nhs.uk", "PointOfContactPhone":"01512281616", "PointOfContactPhoneExt":"1489" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000006493", "InterventionMeshTerm":"Heparin" },{ "InterventionMeshId":"C000006871", "InterventionMeshTerm":"Calcium heparin" },{ "InterventionMeshId":"C000074619", "InterventionMeshTerm":"Bivalirudin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000925", "InterventionAncestorTerm":"Anticoagulants" },{ "InterventionAncestorId":"D000005343", "InterventionAncestorTerm":"Fibrinolytic Agents" },{ "InterventionAncestorId":"D000050299", "InterventionAncestorTerm":"Fibrin Modulating Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000991", "InterventionAncestorTerm":"Antithrombins" },{ "InterventionAncestorId":"D000015842", "InterventionAncestorTerm":"Serine Proteinase Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M8162", "InterventionBrowseLeafName":"Heparin", "InterventionBrowseLeafAsFound":"Unfractionated heparin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M45199", "InterventionBrowseLeafName":"Calcium heparin", "InterventionBrowseLeafAsFound":"Unfractionated heparin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M256171", "InterventionBrowseLeafName":"Bivalirudin", "InterventionBrowseLeafAsFound":"Bivalirudin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2825", "InterventionBrowseLeafName":"Anticoagulants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7056", "InterventionBrowseLeafName":"Fibrinolytic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2888", "InterventionBrowseLeafName":"Antithrombins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2887", "InterventionBrowseLeafName":"Antithrombin III", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16974", "InterventionBrowseLeafName":"Serine Proteinase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T18", "InterventionBrowseLeafName":"Serine", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"AnCoag", "InterventionBrowseBranchName":"Anticoagulants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"AA", "InterventionBrowseBranchName":"Amino Acids" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000009203", "ConditionMeshTerm":"Myocardial Infarction" },{ "ConditionMeshId":"D000072657", "ConditionMeshTerm":"ST Elevation Myocardial Infarction" },{ "ConditionMeshId":"D000007238", "ConditionMeshTerm":"Infarction" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007511", "ConditionAncestorTerm":"Ischemia" },{ "ConditionAncestorId":"D000010335", "ConditionAncestorTerm":"Pathologic Processes" },{ "ConditionAncestorId":"D000009336", "ConditionAncestorTerm":"Necrosis" },{ "ConditionAncestorId":"D000017202", "ConditionAncestorTerm":"Myocardial Ischemia" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M10738", "ConditionBrowseLeafName":"Myocardial Infarction", "ConditionBrowseLeafAsFound":"Myocardial Infarction", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8865", "ConditionBrowseLeafName":"Infarction", "ConditionBrowseLeafAsFound":"Infarction", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M1072", "ConditionBrowseLeafName":"ST Elevation Myocardial Infarction", "ConditionBrowseLeafAsFound":"ST Elevation Myocardial Infarction", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10867", "ConditionBrowseLeafName":"Necrosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5129", "ConditionBrowseLeafName":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M18089", "ConditionBrowseLeafName":"Myocardial Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }