{ "FullStudy":{ "Rank":217902, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515345", "OrgStudyIdInfo":{ "OrgStudyId":"IDEAL-PCI protocol 1.0" }, "Organization":{ "OrgFullName":"Kaiser Franz Josef Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry", "OfficialTitle":"Individualizing Dual Antiplatelet Therapy After Percutaneous Coronary Intervention - The IDEAL-PCI Registry", "Acronym":"IDEAL-PCI" }, "StatusModule":{ "StatusVerifiedDate":"March 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"July 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 3, 2013", "ResultsFirstSubmitQCDate":"March 19, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 1, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 24, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 25, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Prof. Dr. Guenter Christ", "ResponsiblePartyInvestigatorTitle":"Univ. Prof. Dr.", "ResponsiblePartyInvestigatorAffiliation":"Kaiser Franz Josef Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Kaiser Franz Josef Hospital", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to determine the efficacy and safety of a routine individualized antiplatelet therapy after coronary stent implantation by evaluating \"on-treatment\" platelet reactivity with Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer).", "DetailedDescription":"Depending on the clinical presentation patients are treated according to standard operating procedures in our department. The earliest, 12 hours after an initial clopidogrel-loading dose (600mg)\"on-treatment\" platelet reactivity will be determined by Multiple Electrode Aggregometry (MEA, Multiplate® Analyzer), a point of care assay. In case of high residual platelet reactivity (i.e. ≥ 50U), patients are switched according to a therapeutic algorithm to either prasugrel (Efient®), or in case of contraindication (i.e. stroke) to ticagrelor (Brilique®), or in case of contraindication (intracranial hemorrhage) reloaded with clopidogrel." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Platelet Inhibition", "Coronary Stent Implantation" ] }, "KeywordList":{ "Keyword":[ "clopidogrel-nonresponder", "stent thrombosis" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"1008", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"standard therapy", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Clopidogrel" ] } },{ "ArmGroupLabel":"individualized therapy", "ArmGroupType":"Experimental", "ArmGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: prasugrel or ticagrelor" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"prasugrel or ticagrelor", "InterventionDescription":"prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "individualized therapy" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Efient", "Brilique" ] } },{ "InterventionType":"Drug", "InterventionName":"Clopidogrel", "InterventionDescription":"clopidogrel 75mg od for 12 month", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "standard therapy" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Plavix" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Definite Stent Thrombosis", "PrimaryOutcomeDescription":"The angiographic or pathological confirmation of stent thrombosis is called \"definite stent thrombosis\"", "PrimaryOutcomeTimeFrame":"30 days" },{ "PrimaryOutcomeMeasure":"Any Bleeding Event", "PrimaryOutcomeDescription":"Bleeding classified by the TIMI hemorrhage classification scheme:\n\nMinor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL\n\nMajor: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL", "PrimaryOutcomeTimeFrame":"30days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Probable Stent Thrombosis", "SecondaryOutcomeDescription":"Probable stent thrombosis is considered to have occurred in case of\n\nany unexplained death within the first 30 days.\nany MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure", "SecondaryOutcomeTimeFrame":"30days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nall consecutive PCI patients with stent implantation of our institution\n\nExclusion Criteria:\n\npregnancy", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Guenter Christ, MD", "OverallOfficialAffiliation":"Kaiser Franz Josef Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Kaiser Franz Josef Hospital", "LocationCity":"Vienna", "LocationZip":"1100", "LocationCountry":"Austria" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"19264241", "ReferenceType":"background", "ReferenceCitation":"Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schömig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030." },{ "ReferencePMID":"18387444", "ReferenceType":"background", "ReferenceCitation":"Bonello L, Camoin-Jau L, Arques S, Boyer C, Panagides D, Wittenberg O, Simeoni MC, Barragan P, Dignat-George F, Paganelli F. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol. 2008 Apr 8;51(14):1404-11. doi: 10.1016/j.jacc.2007.12.044." },{ "ReferencePMID":"21406646", "ReferenceType":"background", "ReferenceCitation":"Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290. Erratum in: JAMA. 2011 Jun 1;305(21);2174. Stillablower, Michael E [corrected to Stillabower, Michael E]." },{ "ReferencePMID":"25361837", "ReferenceType":"derived", "ReferenceCitation":"Christ G, Siller-Matula JM, Francesconi M, Dechant C, Grohs K, Podczeck-Schweighofer A. Individualising dual antiplatelet therapy after percutaneous coronary intervention: the IDEAL-PCI registry. BMJ Open. 2014 Oct 31;4(10):e005781. doi: 10.1136/bmjopen-2014-005781." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"Related Info", "SeeAlsoLinkURL":"http://www.multiplate.net" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowRecruitmentDetails":"all consecutive PCI patients with stent implantation or drug eluting balloon dilation in our institution until June 2012", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Standard Therapy", "FlowGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Individualized Therapy", "FlowGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"665" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"343" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"664" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"343" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Standard Therapy", "BaselineGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Individualized Therapy", "BaselineGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"665" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"343" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"1008" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"333" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"169" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"502" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"332" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"174" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"506" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"65", "BaselineMeasurementSpread":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"64", "BaselineMeasurementSpread":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"65", "BaselineMeasurementSpread":"12" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"183" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"120" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"303" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"482" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"223" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"705" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Austria", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"665" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"343" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1008" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Definite Stent Thrombosis", "OutcomeMeasureDescription":"The angiographic or pathological confirmation of stent thrombosis is called \"definite stent thrombosis\"", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"30 days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Standard Therapy", "OutcomeGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Individualized Therapy", "OutcomeGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"664" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"343" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Any Bleeding Event", "OutcomeMeasureDescription":"Bleeding classified by the TIMI hemorrhage classification scheme:\n\nMinor: any clinically overt sign of hemorrhage (including imaging) that is associated with a hemoglobin drop of 3 to < 5 g/dL\n\nMajor: (1) if it is intracranial, or (2) clinically significant overt signs of hemorrhage associated with a drop inhemoglobin of > 5 g/dL", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"30days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Standard Therapy", "OutcomeGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Individualized Therapy", "OutcomeGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"664" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"343" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Probable Stent Thrombosis", "OutcomeMeasureDescription":"Probable stent thrombosis is considered to have occurred in case of\n\nany unexplained death within the first 30 days.\nany MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause, irrespective of the time after the index procedure", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"30days", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Standard Therapy", "OutcomeGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Individualized Therapy", "OutcomeGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"664" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"343" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsDescription":"it was not intended to collect adverse events, other than SAEs", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Standard Therapy", "EventGroupDescription":"standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)", "EventGroupSeriousNumAffected":"26", "EventGroupSeriousNumAtRisk":"664", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" },{ "EventGroupId":"EG001", "EventGroupTitle":"Individualized Therapy", "EventGroupDescription":"dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer", "EventGroupSeriousNumAffected":"18", "EventGroupSeriousNumAtRisk":"343", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Definite stentthrombosis", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"1", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"664" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"343" } ] } },{ "SeriousEventTerm":"probable Stentthrombosis", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"2", "SeriousEventStatsNumAffected":"2", "SeriousEventStatsNumAtRisk":"664" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"0", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"343" } ] } },{ "SeriousEventTerm":"Cardiovascular death", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"664" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"9", "SeriousEventStatsNumAffected":"9", "SeriousEventStatsNumAtRisk":"343" } ] } },{ "SeriousEventTerm":"Bleeding (TIMI major)", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"6", "SeriousEventStatsNumAffected":"6", "SeriousEventStatsNumAtRisk":"664" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"343" } ] } },{ "SeriousEventTerm":"Bleeding (TIMI minor)", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"11", "SeriousEventStatsNumAffected":"11", "SeriousEventStatsNumAtRisk":"664" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"5", "SeriousEventStatsNumAffected":"5", "SeriousEventStatsNumAtRisk":"343" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Univ.Prof. Dr Günter Christ", "PointOfContactOrganization":"Kaiser Franz Josef Hospital", "PointOfContactEMail":"guenter.christ@wienkav.at", "PointOfContactPhone":"+43160191", "PointOfContactPhoneExt":"2508" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077144", "InterventionMeshTerm":"Clopidogrel" },{ "InterventionMeshId":"D000077486", "InterventionMeshTerm":"Ticagrelor" },{ "InterventionMeshId":"D000068799", "InterventionMeshTerm":"Prasugrel Hydrochloride" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000010975", "InterventionAncestorTerm":"Platelet Aggregation Inhibitors" },{ "InterventionAncestorId":"D000058921", "InterventionAncestorTerm":"Purinergic P2Y Receptor Antagonists" },{ "InterventionAncestorId":"D000058919", "InterventionAncestorTerm":"Purinergic P2 Receptor Antagonists" },{ "InterventionAncestorId":"D000058914", "InterventionAncestorTerm":"Purinergic Antagonists" },{ "InterventionAncestorId":"D000058905", "InterventionAncestorTerm":"Purinergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M1812", "InterventionBrowseLeafName":"Ticagrelor", "InterventionBrowseLeafAsFound":"Ticagrelor", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1669", "InterventionBrowseLeafName":"Clopidogrel", "InterventionBrowseLeafAsFound":"Clopidogrel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M310", "InterventionBrowseLeafName":"Prasugrel Hydrochloride", "InterventionBrowseLeafAsFound":"Prasugrel", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M12448", "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27881", "InterventionBrowseLeafName":"Purinergic P2Y Receptor Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"PlAggInh", "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M15269", "ConditionBrowseLeafName":"Thrombosis", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }