Nctid:
NCT06224582
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000060050", "term"=>"Angina, Stable"}, {"id"=>"D000002637", "term"=>"Chest Pain"}], "ancestors"=>[{"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}, {"id"=>"D000000787", "term"=>"Angina Pectoris"}, {"id"=>"D000017202", "term"=>"Myocardial Ischemia"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}], "browseLeaves"=>[{"id"=>"M5882", "name"=>"Chest Pain", "asFound"=>"Chest Pain", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M4117", "name"=>"Angina Pectoris", "relevance"=>"LOW"}, {"id"=>"M29575", "name"=>"Angina, Stable", "asFound"=>"Chronic Stable Angina", "relevance"=>"HIGH"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"M19506", "name"=>"Myocardial Ischemia", "relevance"=>"LOW"}, {"id"=>"M6546", "name"=>"Coronary Artery Disease", "relevance"=>"LOW"}, {"id"=>"M10543", "name"=>"Ischemia", "relevance"=>"LOW"}, {"id"=>"M9419", "name"=>"Heart Diseases", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21860", "name"=>"Pharmaceutical Solutions", "relevance"=>"LOW"}, {"id"=>"T167", "name"=>"Ginkgo", "asFound"=>"SUBA-itraconazole", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Pharmaceutical Solutions", "abbrev"=>"PhSol"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>320}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-12-30", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2021-03", "completionDateStruct"=>{"date"=>"2023-12-25", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2024-01-16", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-25", "type"=>"ACTUAL"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"SAQ-PL", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"Physical limitation assessed on the basis of Seattle Angina Questionnaire"}, {"measure"=>"SAQ-AS", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"Anginal stability assessed on the basis of Seattle Angina Questionnaire"}, {"measure"=>"SAQ-TS", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"Treatment satisfaction assessed on the basis of Seattle Angina Questionnaire"}, {"measure"=>"SAQ-DP", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"Disease perception assessed on the basis of Seattle Angina Questionnaire"}], "primaryOutcomes"=>[{"measure"=>"SAQ-angina frequency", "timeFrame"=>"at 12-week follow-up", "description"=>"angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ-AF)"}], "secondaryOutcomes"=>[{"measure"=>"HAMA improvement", "timeFrame"=>"at 12-week follow-up", "description"=>"variation of the value of Hamilton Anxiety Scale (HAMA) at 12-week follow-up compared with baseline"}, {"measure"=>"CCS grade", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"angina grade assessed by Canadian Cardiovascular Society (CCS)"}, {"measure"=>"NYHA class", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"heart function assessed by New York Heart Association (NYHA)"}, {"measure"=>"VAS", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"generic health status assessed by visual analogue scale (VAS)"}, {"measure"=>"HAMA reductive ratio", "timeFrame"=>"at 12-week follow-up", "description"=>"variation of Hamilton Anxiety Scale (HAMA) score at 12-week follow-up compared with baseline divided by the baseline value"}, {"measure"=>"HAMD depression score", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"proportion of participants with improvement or disappear of depression according to Hamilton Depression Scale (HAMD)"}, {"measure"=>"weekly angina frequency", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"weekly angina frequency recorded by the participants' diary cards"}, {"measure"=>"SF-12 score", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"generic health status measured by 12-Item Short Form Health Survey (SF-12)"}, {"measure"=>"Nitroglycerin discontinuation rate", "timeFrame"=>"before randomization, in 4,8,12,16 and 20 weeks", "description"=>"proportion of participants that no longer need any nitroglycerin medications"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Chronic Stable Angina"]}, "descriptionModule"=>{"briefSummary"=>"A prospective, multi-center, double-blind, randomized, placebo-controlled trial is conducted to evaluate the efficacy and safety of Yinxingmihuan oral solution in the treatment of chest pain after percutaneous coronary intervention (PCI) in patients with stable angina. Patients should undergo at least 1-week standardized medical treatment phase before randomization. The primary end point is the 12-week angina frequency assessed on the basis of Seattle Angina Questionnaire (SAQ) subscales. The main secondary endpoint is the improvement of anxiety assessed by Hamilton Anxiety Scale (HAMA) to evaluate its effectiveness for chest pain caused by psychological factors."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"85 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* male or female aged 18-85 years;\n* patients with a history of percutaneous coronary intervention for coronary heart disease for more than 30 days and less than 180 days, without need of further elective coronary revascularization (PCI, CABG) judged by cardiovascular specialists;\n* patients with symptoms such as chest distress, chest pain, palpitation, pain in shoulder and back, shortness of breath, weakness, activity intolerance, etc. Angina frequency (AF) score in Seattle Angina Questionnaire (SAQ) no more than 80;\n* Hamilton Anxiety Scale score between 7 and 21 (mild to moderate anxiety);\n* written informed consent.\n\nExclusion Criteria:\n\n* women who are pregnant or preparing to be pregnant or nursing, menstruating women;\n* women of child-bearing age who do not agree to use contraception during the medication phase;\n* patients with severe anxiety (Hamilton Anxiety Scale score more than 21);\n* patients with severe depression (Hamilton Depression Scale score not less than 24);\n* patients who are currently taking anti-anxiety drug;\n* participants with stable angina classified into Canadian Cardiovascular Society (CCS) Grade 4;\n* uncontrolled hypertension (systolic \\> 180 mmHg or diastolic \\> 100 mmHg) despite using ongoing antihypertensive treatment;\n* heart failure assessed by New York Heart Association (NYHA);\n* patients with coronary heart disease and atrial fibrillation;\n* clinically significant complications, including liver dysfunction (ALT or AST level more than 2 times higher than normal), renal dysfunction (serum creatinine level more than 2 times higher than normal), severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, history of cerebral hemorrhage or epilepsy, with need of anticonvulsant drugs;\n* within 7 days of introduction period, patients who no longer have angina-related symptoms;\n* within the three months before start of the study, patients with myocardial infarction or CCS 4 angina;\n* patients with acute coronary syndrome confirmed by examinations and other chest pain caused by rheumatic heart disease, dilated cardiomyopathy, severe neurosis, menopausal syndrome, hyperthyroidism, cervical spondylosis, bilio-cardiac syndrome, gastroesophageal reflux, hiatal hernia, aortic dissection, pulmonary embolism, mediastinal hematoma, etc;\n* history of specific bleeding or bleeding caused by warfarin;\n* patients with previous hematopoietic diseases;\n* patients who have undergone surgery (not including PCI) within the last 4 weeks and are prone to bleeding;\n* patients who participate in any other clinical study or take any other investigational drug within 90 days;\n* patients who are known or suspected to be allergic to the drug in this study or are allergic constitution;\n* drug abusers who have a history of alcohol abuse or drug dependence in the past 2 years;\n* psychopath;\n* patients who have been judged by their doctors to be ineligible for the study;\n* patient who is a family member or relative of the staff working in the centers."}, "identificationModule"=>{"nctId"=>"NCT06224582", "briefTitle"=>"Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"China National Center for Cardiovascular Diseases"}, "officialTitle"=>"Efficacy and Safety of Yinxingmihuan Oral Solution in Treatment of Chest Pain After PCI: A Multicenter, Prospective, Randomized, Double-blind, Placebo-Controlled Study", "orgStudyIdInfo"=>{"id"=>"Yinxingmihuan01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Yinxingmihuan group", "description"=>"standardized medical treatment regimen plus Yinxingmihuan oral solution (oral, 10 ml once, 3 times a day)", "interventionNames"=>["Drug: Yinxingmihuan oral solution"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo group", "description"=>"standardized medical treatment regimen plus Placebo oral solution (oral, 10 ml once, 3 times a day)", "interventionNames"=>["Drug: Placebo"]}], "interventions"=>[{"name"=>"Yinxingmihuan oral solution", "type"=>"DRUG", "otherNames"=>["Ginkgo leaf extract and armillariella mellea powders"], "description"=>"Yinxingmihuan oral solution is made of Ginkgo leaf extract and armillariella mellea powders.", "armGroupLabels"=>["Yinxingmihuan group"]}, {"name"=>"Placebo", "type"=>"DRUG", "description"=>"The placebo oral solution is in the same appearance, color, smell and taste as the experimental Yinxingmihuan oral solution.", "armGroupLabels"=>["Placebo group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100037", "city"=>"Beijing", "country"=>"China", "facility"=>"Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"China National Center for Cardiovascular Diseases", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
