{ "FullStudy":{ "Rank":217987, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514227", "OrgStudyIdInfo":{ "OrgStudyId":"NIPPON 5.0" }, "Organization":{ "OrgFullName":"Associations for Establishment of Evidence in Interventions", "OrgClass":"OTHER" }, "BriefTitle":"Nobori Dual Antiplatelet Therapy as Appropriate Duration", "OfficialTitle":"Nobori Dual Antiplatelet Therapy as Appropriate Duration." }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2016", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 22, 2011", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 26, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 27, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Associations for Establishment of Evidence in Interventions", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Coronary Artery Disease" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"3773", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Short-term DAPT (6 months) group", "ArmGroupType":"Experimental", "ArmGroupDescription":"6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Aspirin or thienopyridine" ] } },{ "ArmGroupLabel":"Long-term DAPT (18 months) group", "ArmGroupType":"Experimental", "ArmGroupDescription":"18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Aspirin and thienopyridine" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Aspirin or thienopyridine", "InterventionDescription":"Subjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Short-term DAPT (6 months) group" ] } },{ "InterventionType":"Drug", "InterventionName":"Aspirin and thienopyridine", "InterventionDescription":"Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Long-term DAPT (18 months) group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Net adverse clinical and cerebral event (NACCE)", "PrimaryOutcomeDescription":"NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.", "PrimaryOutcomeTimeFrame":"18 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"All-cause death", "SecondaryOutcomeTimeFrame":"18 months" },{ "SecondaryOutcomeMeasure":"Non-fatal myocardial infarction", "SecondaryOutcomeTimeFrame":"18 months" },{ "SecondaryOutcomeMeasure":"Cerebrovascular events", "SecondaryOutcomeTimeFrame":"18 months" },{ "SecondaryOutcomeMeasure":"Major bleeding", "SecondaryOutcomeTimeFrame":"18 months" },{ "SecondaryOutcomeMeasure":"Rate of target lesion revascularization", "SecondaryOutcomeTimeFrame":"18 months" },{ "SecondaryOutcomeMeasure":"Minor bleeding", "SecondaryOutcomeTimeFrame":"18 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects > 20 years old\nUndergoing percutaneous intervention with Nobori deployment\nNo contraindication to prolonged DAPT\n\nExclusion Criteria:\n\nSubjects absolutely necessitating continuous DAPT\nPlanned surgery necessitating discontinuation of antiplatelet therapy after enrollment.\nActive pathological bleeding\nStatus of cardiogenic shock at enrollment\nPregnant women\nLife expectancy of < 1.5 years\nSubjects unable to give informed consent\nEpisode of stroke < 6 months\nSubjects with allergies or hypersensitivity to material of coating, Biolimus A9, and antiplatelet drugs.\nSubjects treated with other kind of DES or BMS during the index procedure\nPrevious intervention with DES < 6 months.\nStudy participation impractical per investigator judgment", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "LocationList":{ "Location":[ { "LocationFacility":"Non-profit organization Associations for Establishment of Evidence in Interventions", "LocationCity":"Minato-ku", "LocationState":"Tokyo", "LocationZip":"105-0013", "LocationCountry":"Japan" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28641838", "ReferenceType":"derived", "ReferenceCitation":"Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H; NIPPON Investigators. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2017 Jun 26;10(12):1189-1198. doi: 10.1016/j.jcin.2017.04.019." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000001241", "InterventionMeshTerm":"Aspirin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000018501", "InterventionAncestorTerm":"Antirheumatic Agents" },{ "InterventionAncestorId":"D000005343", "InterventionAncestorTerm":"Fibrinolytic Agents" },{ "InterventionAncestorId":"D000050299", "InterventionAncestorTerm":"Fibrin Modulating Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000010975", "InterventionAncestorTerm":"Platelet Aggregation Inhibitors" },{ "InterventionAncestorId":"D000016861", "InterventionAncestorTerm":"Cyclooxygenase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000058633", "InterventionAncestorTerm":"Antipyretics" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M3129", "InterventionBrowseLeafName":"Aspirin", "InterventionBrowseLeafAsFound":"Aspirin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19370", "InterventionBrowseLeafName":"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7056", "InterventionBrowseLeafName":"Fibrinolytic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12448", "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M17792", "InterventionBrowseLeafName":"Cyclooxygenase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27763", "InterventionBrowseLeafName":"Antipyretics", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Antipy", "InterventionBrowseBranchName":"Antipyretics" },{ "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"PlAggInh", "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000003324", "ConditionMeshTerm":"Coronary Artery Disease" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000003327", "ConditionAncestorTerm":"Coronary Disease" },{ "ConditionAncestorId":"D000017202", "ConditionAncestorTerm":"Myocardial Ischemia" },{ "ConditionAncestorId":"D000006331", "ConditionAncestorTerm":"Heart Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000001161", "ConditionAncestorTerm":"Arteriosclerosis" },{ "ConditionAncestorId":"D000001157", "ConditionAncestorTerm":"Arterial Occlusive Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5129", "ConditionBrowseLeafName":"Coronary Artery Disease", "ConditionBrowseLeafAsFound":"Coronary Artery Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18089", "ConditionBrowseLeafName":"Myocardial Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5132", "ConditionBrowseLeafName":"Coronary Disease", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3050", "ConditionBrowseLeafName":"Arteriosclerosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3046", "ConditionBrowseLeafName":"Arterial Occlusive 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" } ] } } } } } }