{ "FullStudy":{ "Rank":218074, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513070", "OrgStudyIdInfo":{ "OrgStudyId":"SUXIAOJIUXIN2010" }, "Organization":{ "OrgFullName":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences", "OrgClass":"OTHER" }, "BriefTitle":"A Clinical Trials of Quick-Acting Heart Reliever for Moderate Coronary Stenosis", "OfficialTitle":"A Randomized Double-blind Placebo-controlled Clinical Trials of the Blood-quickening Stasis-transforming Formula Quick-Acting Heart Reliever for Patients With Moderate Coronary Stenosis" }, "StatusModule":{ "StatusVerifiedDate":"August 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"April 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"July 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 16, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 3, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 5, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Jie Wang", "ResponsiblePartyInvestigatorTitle":"President of Guang'anmen Hospital", "ResponsiblePartyInvestigatorAffiliation":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences" }, "LeadSponsor":{ "LeadSponsorName":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"This study investigates the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with moderate coronary stenosis for six months. At the same time, the studying will assess the plaque, myocardial blood-supplying,quality of life and observe the end point of the heart (including the myocardial revascularization, death and myocardial infarction). The purpose is to study the function of the blood-quickening stasis-transforming formula Quick-Acting Heart Reliever for moderate coronary stenosis lesions.", "DetailedDescription":"Blood-quickening stasis-transforming medicinal of Chinese medicinal can ameliorate clinical symptoms of coronary artery disease. Quick-Acting Heart Reliever is one of blood-quickening stasis-transforming medicinals to relieve angina pectoris in clinic and is especially benefit for the patients with moderate coronary stenosis who need not coronary revascularization only have medical treatment. But there is no randomized evidence that established the beneficial effects of blood-quickening stasis-transforming medicinals to treat moderate coronary stenosis lesions. This study is a randomized double-blind placebo-controlled clinical trials. A total of 120 consecutive participants with at least one moderate coronary stenosis lesion (diameter stenosis 50-75%) will be randomized to two groups: group 1(n =60) will receive Quick-Acting Heart and the placebo of isosorbide dinitrate, patients in group 2(n = 60) will receive isosorbide dinitrate and the placebo of Quick-Acting Heart for six months. The myocardial perfusion imaging and the coronary CT angiography will be used to evaluate the effective power of angina pectoris,myocardial blood-supplying，the quality and volume of the plaque, diameter stenosis after treating after 6 months and the end point of the heart (including death，myocardial infarction and myocardial revascularization which includes intracoronary stenting and coronary artery bypass grafting,) after 12 months. The purpose is to study the function of Quick-Acting Heart Reliever delaying percutaneous coronary intervention(PCI) for moderate coronary stenosis." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Coronary Artery Stenosis", "Coronary Heart Disease" ] }, "KeywordList":{ "Keyword":[ "Quick-Acting Heart Reliever", "Coronary Artery Stenosis", "Coronary Heart Disease", "Suxiao Jiuxin Pill", "Chinese Herbal Drugs", "Traditional Chinese Medicine", "Chinese Medicine", "Angina Pectoris", "Isosorbide Dinitrate", "Myocardial Perfusion Imaging", "Clinical Trial" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"120", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Quick-Acting Heart Reliever group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Drug: Quick-Acting Heart Reliever and Placebo of isosorbide dinitrate and Aspirin Enteric-coated Tablets", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Quick-Acting Heart Reliever", "Drug: Placebo of Isosorbide Dinitrate", "Drug: Aspirin Enteric-coated Tablets" ] } },{ "ArmGroupLabel":"Isosorbide Dinitrate group", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Isosorbide Dinitrate and Placebo of Quick-Acting Heart Reliever and Aspirin Enteric-coated Tablets", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Isosorbide Dinitrate", "Drug: Placebo of Quick-Acting Heart Reliever", "Drug: Aspirin Enteric-coated Tablets" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Quick-Acting Heart Reliever", "InterventionDescription":"Quick-Acting Heart Reliever，200mg，tid，po. for six months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quick-Acting Heart Reliever group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Suxiao Jiuxin Pill" ] } },{ "InterventionType":"Drug", "InterventionName":"Isosorbide Dinitrate", "InterventionDescription":"Isosorbide Dinitrate，10mg，tid，po. for six months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Isosorbide Dinitrate group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Cedocard，Nitrosorbide， Vascardin" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo of Isosorbide Dinitrate", "InterventionDescription":"Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quick-Acting Heart Reliever group" ] } },{ "InterventionType":"Drug", "InterventionName":"Aspirin Enteric-coated Tablets", "InterventionDescription":"Aspirin Enteric-coated Tablets，100mg，qd，po. for six months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Quick-Acting Heart Reliever group" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo of Quick-Acting Heart Reliever", "InterventionDescription":"Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Isosorbide Dinitrate group" ] } },{ "InterventionType":"Drug", "InterventionName":"Aspirin Enteric-coated Tablets", "InterventionDescription":"Aspirin Enteric-coated Tablets，100mg，qd，po. for six months", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Isosorbide Dinitrate group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"the effective power of angina pectoris", "PrimaryOutcomeDescription":"the effective power of angina pectoris after Quick-Acting Heart Reliever and isosorbide dinitrate interventing respectively the patients with morderate coronary stenosis for six months", "PrimaryOutcomeTimeFrame":"6 months" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"plaque", "SecondaryOutcomeDescription":"Assess the plaque by the coronary CT angiography", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"myocardium blood-supply", "SecondaryOutcomeDescription":"Evaluate the myocardium blood-supply by the myocardial perfusion imaging", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"the end point of the heart(a composite of cardiovascular events including death, nonfatal myocardial infarction,coronary revascularization, hospitalized unstable angina)", "SecondaryOutcomeTimeFrame":"12 months" },{ "SecondaryOutcomeMeasure":"symptoms score", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"quality of life", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"MMP-9", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"SCD40L", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"VEGF", "SecondaryOutcomeTimeFrame":"6 months" },{ "SecondaryOutcomeMeasure":"bFGF", "SecondaryOutcomeTimeFrame":"6 months" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female subjects 30-75 years of age\nAngina or CAD patient\nDiameter stenosis 50-75% in at least one main coronary artery (Confirmed by coronary arteriography or coronary CT angiography)\nNot received percutaneous coronary intervention(PCI)\nHeart blood stasis obstruction syndrome according to TCM syndrome differentiation\nProvide written informed consent.\n\nExclusion Criteria:\n\nHeart transplant or history of CABG or history of percutaneous transluminal coronary angioplasty (PTCA) with a drug-eluting stent.\nLeft ventricular ejection fraction < 35%\nAcute myocardial infarction within 4 weeks prior to inclusion\nThe contractive pressure > 160 mmHg or diastolic pressure >100 mmHg\nSevere valvular heart disease\nInsulin-dependent diabetes mellitus\nSerious heart, lung, liver, kidney and brain or other primary complications\nMental patients\nDiagnosed or suspected tumor\nAllergic persons\nPregnant, breastfeeding, or intends to become pregnant during the course of the study (females only)\nPatients not willing to or not able to give the informed consent to participate in the study\nThe patients who are attending other clinical trial\nThe person maybe loss for some reason such as work or life condition according to the investigator's judgement", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"30 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Jie Wang, MD", "OverallOfficialAffiliation":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences", "LocationCity":"Beijing", "LocationState":"Beijing", "LocationZip":"100053", "LocationCountry":"China" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000001241", "InterventionMeshTerm":"Aspirin" },{ "InterventionMeshId":"D000007547", "InterventionMeshTerm":"Isosorbide" },{ "InterventionMeshId":"D000007548", "InterventionMeshTerm":"Isosorbide Dinitrate" },{ "InterventionMeshId":"C000030397", "InterventionMeshTerm":"Isosorbide-5-mononitrate" } ] }, "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" },{ "InterventionAncestorId":"D000004234", "InterventionAncestorTerm":"Diuretics, Osmotic" },{ "InterventionAncestorId":"D000004232", "InterventionAncestorTerm":"Diuretics" },{ "InterventionAncestorId":"D000045283", "InterventionAncestorTerm":"Natriuretic Agents" },{ "InterventionAncestorId":"D000014665", "InterventionAncestorTerm":"Vasodilator Agents" },{ "InterventionAncestorId":"D000020030", "InterventionAncestorTerm":"Nitric Oxide Donors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M3129", "InterventionBrowseLeafName":"Aspirin", "InterventionBrowseLeafAsFound":"Aspirin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M9161", "InterventionBrowseLeafName":"Isosorbide", "InterventionBrowseLeafAsFound":"Isosorbide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M9162", "InterventionBrowseLeafName":"Isosorbide Dinitrate", "InterventionBrowseLeafAsFound":"Isosorbide Dinitrate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M252616", "InterventionBrowseLeafName":"Isosorbide-5-mononitrate", "InterventionBrowseLeafAsFound":"Isosorbide Dinitrate", "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" },{ "InterventionBrowseLeafId":"M5994", "InterventionBrowseLeafName":"Diuretics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15995", "InterventionBrowseLeafName":"Vasodilator Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M11090", "InterventionBrowseLeafName":"Nitric Oxide", "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" },{ "InterventionBrowseBranchAbbrev":"NaAg", "InterventionBrowseBranchName":"Natriuretic Agents" },{ "InterventionBrowseBranchAbbrev":"NiOxD", "InterventionBrowseBranchName":"Nitric Oxide Donors" },{ "InterventionBrowseBranchAbbrev":"VaDiAg", "InterventionBrowseBranchName":"Vasodilator Agents" },{ "InterventionBrowseBranchAbbrev":"Resp", "InterventionBrowseBranchName":"Respiratory System Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000006331", "ConditionMeshTerm":"Heart Diseases" },{ "ConditionMeshId":"D000003327", "ConditionMeshTerm":"Coronary Disease" },{ "ConditionMeshId":"D000003324", "ConditionMeshTerm":"Coronary Artery Disease" },{ "ConditionMeshId":"D000017202", "ConditionMeshTerm":"Myocardial Ischemia" },{ "ConditionMeshId":"D000023921", "ConditionMeshTerm":"Coronary Stenosis" },{ "ConditionMeshId":"D000003251", "ConditionMeshTerm":"Constriction, Pathologic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000020763", "ConditionAncestorTerm":"Pathological Conditions, Anatomical" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000001161", "ConditionAncestorTerm":"Arteriosclerosis" },{ "ConditionAncestorId":"D000001157", "ConditionAncestorTerm":"Arterial Occlusive Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M5058", "ConditionBrowseLeafName":"Constriction, Pathologic", "ConditionBrowseLeafAsFound":"Stenosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5129", "ConditionBrowseLeafName":"Coronary Artery Disease", "ConditionBrowseLeafAsFound":"Coronary Heart Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M21497", "ConditionBrowseLeafName":"Coronary Stenosis", "ConditionBrowseLeafAsFound":"Coronary Artery Stenosis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8002", "ConditionBrowseLeafName":"Heart Diseases", "ConditionBrowseLeafAsFound":"Heart Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M18089", "ConditionBrowseLeafName":"Myocardial Ischemia", "ConditionBrowseLeafAsFound":"Coronary Heart Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5132", "ConditionBrowseLeafName":"Coronary Disease", "ConditionBrowseLeafAsFound":"Coronary Heart Disease", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2698", "ConditionBrowseLeafName":"Angina Pectoris", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M21103", "ConditionBrowseLeafName":"Pathological Conditions, Anatomical", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3050", "ConditionBrowseLeafName":"Arteriosclerosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3046", "ConditionBrowseLeafName":"Arterial Occlusive Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" } ] } } } } } }