{ "FullStudy":{ "Rank":217789, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516814", "OrgStudyIdInfo":{ "OrgStudyId":"15960" }, "Organization":{ "OrgFullName":"Bayer", "OrgClass":"INDUSTRY" }, "BriefTitle":"Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients", "OfficialTitle":"Randomized, Open-label, Parallel-group, Active-controlled Study of Rivaroxaban in Patients With Acute Symptomatic Pulmonary Embolism, With or Without Symptomatic Deep Vein Thrombosis" }, "StatusModule":{ "StatusVerifiedDate":"January 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 20, 2012", "StudyFirstSubmitQCDate":"January 20, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 19, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 23, 2017", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Bayer", "LeadSponsorClass":"INDUSTRY" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Janssen Research & Development, LLC", "CollaboratorClass":"INDUSTRY" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Pulmonary Embolism" ] }, "KeywordList":{ "Keyword":[ "acute symptomatic pulmonary embolism" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Arm 1", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Rivaroxaban (Xarelto, BAY59-7939)" ] } },{ "ArmGroupLabel":"Arm 2", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Unfractionated heparin" ] } },{ "ArmGroupLabel":"Arm 3", "ArmGroupType":"Active Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Warfarin" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Rivaroxaban (Xarelto, BAY59-7939)", "InterventionDescription":"15 mg twice daily for 21 days, followed by 15 mg once daily", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 1" ] } },{ "InterventionType":"Drug", "InterventionName":"Unfractionated heparin", "InterventionDescription":"To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 2" ] } },{ "InterventionType":"Drug", "InterventionName":"Warfarin", "InterventionDescription":"To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Arm 3" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Number of participants with newly onset of symptomatic venous thromboembolism (VTE)", "PrimaryOutcomeTimeFrame":"Up to 12 months" },{ "PrimaryOutcomeMeasure":"Number of clinically relevant bleedings", "PrimaryOutcomeTimeFrame":"Up to 2 days after last dose" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Number of participants with improvement in thrombotic burden", "SecondaryOutcomeTimeFrame":"At week 3" },{ "SecondaryOutcomeMeasure":"Number of participants with deterioration in thrombotic burden", "SecondaryOutcomeTimeFrame":"Up to 12 months" },{ "SecondaryOutcomeMeasure":"Number of participants with the composite of newly onset of symptomatic VTE or asymptomatic deterioration of thrombus", "SecondaryOutcomeTimeFrame":"Up to 12 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women >/= 20 years of age in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic deep vein thrombosis (DVT)\n\nExclusion Criteria:\n\nThrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of PE\nMore than 48 hours pre-randomization treatment with therapeutic dosages of anti-coagulant treatment or more than a single dose of warfarin from the onset of the current episode of PE to randomization\nCalculated creatinine clearance (CLCR) < 30 mL/min\nSubjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk\nActive bleeding or high risk for bleeding contraindicating treatment with unfractioned Heparin (UFH) or warfarin\nSystolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"20 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Bayer Study Director", "OverallOfficialAffiliation":"Bayer", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationCity":"Nagoya", "LocationState":"Aichi", "LocationZip":"457-8510", "LocationCountry":"Japan" },{ "LocationCity":"Toyoake", "LocationState":"Aichi", "LocationZip":"470-1192", "LocationCountry":"Japan" },{ "LocationCity":"Sakura", "LocationState":"Chiba", "LocationZip":"285-8741", "LocationCountry":"Japan" },{ "LocationCity":"Kurume", "LocationState":"Fukuoka", "LocationZip":"830-8543", "LocationCountry":"Japan" },{ "LocationCity":"Maebashi", "LocationState":"Gunma", "LocationZip":"371-8511", "LocationCountry":"Japan" },{ "LocationCity":"Sapporo", "LocationState":"Hokkaido", "LocationZip":"006-8555", "LocationCountry":"Japan" },{ "LocationCity":"Kahoku-gun", "LocationState":"Ishikawa", "LocationZip":"920-0293", "LocationCountry":"Japan" },{ "LocationCity":"Kanazawa", "LocationState":"Ishikawa", "LocationZip":"920-8650", "LocationCountry":"Japan" },{ "LocationCity":"Yokohama", "LocationState":"Kanagawa", "LocationZip":"245-8575", "LocationCountry":"Japan" },{ "LocationCity":"Tsu", "LocationState":"Mie", "LocationZip":"514-8507", "LocationCountry":"Japan" },{ "LocationCity":"Matsumoto", "LocationState":"Nagano", "LocationZip":"390-8510", "LocationCountry":"Japan" },{ "LocationCity":"Suwa", "LocationState":"Nagano", "LocationZip":"392-8510", "LocationCountry":"Japan" },{ "LocationCity":"Osakasayama", "LocationState":"Osaka", "LocationZip":"589-8511", "LocationCountry":"Japan" },{ "LocationCity":"Suita", "LocationState":"Osaka", "LocationZip":"565-8565", "LocationCountry":"Japan" },{ "LocationCity":"Shimotsuke", "LocationState":"Tochigi", "LocationZip":"329-0498", "LocationCountry":"Japan" },{ "LocationCity":"Bunkyo-ku", "LocationState":"Tokyo", "LocationZip":"113-8519", "LocationCountry":"Japan" },{ "LocationCity":"Bunkyo-ku", "LocationState":"Tokyo", "LocationZip":"113-8655", "LocationCountry":"Japan" },{ "LocationCity":"Chuoku", "LocationState":"Tokyo", "LocationZip":"104-8560", "LocationCountry":"Japan" },{ "LocationCity":"Itabashi-ku", "LocationState":"Tokyo", "LocationZip":"173-8610", "LocationCountry":"Japan" },{ "LocationCity":"Meguro-ku", "LocationState":"Tokyo", "LocationZip":"152-8902", "LocationCountry":"Japan" },{ "LocationCity":"Shinagawa", "LocationState":"Tokyo", "LocationZip":"141-8625", "LocationCountry":"Japan" },{ "LocationCity":"Shinjuku-ku", "LocationState":"Tokyo", "LocationZip":"162-8655", "LocationCountry":"Japan" },{ "LocationCity":"Aomori", "LocationZip":"030-8553", "LocationCountry":"Japan" },{ "LocationCity":"Chiba", "LocationZip":"260-8677", "LocationCountry":"Japan" },{ "LocationCity":"Kumamoto", "LocationZip":"862-8505", "LocationCountry":"Japan" },{ "LocationCity":"Niigata", "LocationZip":"951-8520", "LocationCountry":"Japan" },{ "LocationCity":"Osaka", "LocationZip":"530-8480", "LocationCountry":"Japan" },{ "LocationCity":"Osaka", "LocationZip":"537-8511", "LocationCountry":"Japan" },{ "LocationCity":"Osaka", "LocationZip":"553-0003", "LocationCountry":"Japan" },{ "LocationCity":"Saga", "LocationZip":"840-8571", "LocationCountry":"Japan" },{ "LocationCity":"Shizuoka", "LocationZip":"424-8636", "LocationCountry":"Japan" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25851062", "ReferenceType":"derived", "ReferenceCitation":"Matsuo H, Prins M, Lensing AW, Fujinuma EW, Miyamoto Y, Kajikawa M. Shortened length of hospital stay with rivaroxaban in patients with symptomatic venous thromboembolism in Japan: the J-EINSTEIN pulmonary embolism and deep vein thrombosis program. Curr Med Res Opin. 2015 Jun;31(6):1057-61. doi: 10.1185/03007995.2015.1037728. Epub 2015 May 11." },{ "ReferencePMID":"25717286", "ReferenceType":"derived", "ReferenceCitation":"Yamada N, Hirayama A, Maeda H, Sakagami S, Shikata H, Prins MH, Lensing AW, Kato M, Onuma J, Miyamoto Y, Iekushi K, Kajikawa M. Oral rivaroxaban for Japanese patients with symptomatic venous thromboembolism - the J-EINSTEIN DVT and PE program. Thromb J. 2015 Jan 17;13:2. doi: 10.1186/s12959-015-0035-3. eCollection 2015. Erratum in: Thromb J. 2016;14:11." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000006493", "InterventionMeshTerm":"Heparin" },{ "InterventionMeshId":"C000006871", "InterventionMeshTerm":"Calcium heparin" },{ "InterventionMeshId":"D000014859", "InterventionMeshTerm":"Warfarin" },{ "InterventionMeshId":"D000069552", "InterventionMeshTerm":"Rivaroxaban" } ] }, "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":"D000065427", "InterventionAncestorTerm":"Factor Xa Inhibitors" },{ "InterventionAncestorId":"D000000991", "InterventionAncestorTerm":"Antithrombins" },{ "InterventionAncestorId":"D000015842", "InterventionAncestorTerm":"Serine Proteinase Inhibitors" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M463", "InterventionBrowseLeafName":"Rivaroxaban", "InterventionBrowseLeafAsFound":"Rivaroxaban", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M8162", "InterventionBrowseLeafName":"Heparin", "InterventionBrowseLeafAsFound":"Unfractionated heparin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M45199", "InterventionBrowseLeafName":"Calcium heparin", "InterventionBrowseLeafAsFound":"Unfractionated heparin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16185", "InterventionBrowseLeafName":"Warfarin", "InterventionBrowseLeafAsFound":"Warfarin", "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":"M29100", "InterventionBrowseLeafName":"Factor Xa Inhibitors", "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":"AnCoag", "InterventionBrowseBranchName":"Anticoagulants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"AA", "InterventionBrowseBranchName":"Amino Acids" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000011655", "ConditionMeshTerm":"Pulmonary Embolism" },{ "ConditionMeshId":"D000004617", "ConditionMeshTerm":"Embolism" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000016769", "ConditionAncestorTerm":"Embolism and Thrombosis" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000008171", "ConditionAncestorTerm":"Lung Diseases" },{ "ConditionAncestorId":"D000012140", "ConditionAncestorTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M15269", "ConditionBrowseLeafName":"Thrombosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13092", "ConditionBrowseLeafName":"Pulmonary Embolism", "ConditionBrowseLeafAsFound":"Pulmonary Embolism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M6367", "ConditionBrowseLeafName":"Embolism", "ConditionBrowseLeafAsFound":"Embolism", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M20655", "ConditionBrowseLeafName":"Venous Thrombosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15265", "ConditionBrowseLeafName":"Thromboembolism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M26367", "ConditionBrowseLeafName":"Venous Thromboembolism", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M17711", "ConditionBrowseLeafName":"Embolism and Thrombosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" } ] } } } } } }