Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-02 @ 7:34 AM
Study NCT ID:
NCT01897805
Status:
UNKNOWN
Last Update Posted:
2014-12-19
First Post:
2013-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial to Evaluate Efficacy of Heart-protecting Musk Pill
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2013-07-09', 'studyFirstSubmitQcDate': '2013-07-09', 'lastUpdatePostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidence of adverse event', 'timeFrame': '24 months'}], 'primaryOutcomes': [{'measure': 'The combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'The combined incidence of all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina or heart failure, and peripheral revascularization (PCI or CABG)', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '36386372', 'type': 'DERIVED', 'citation': 'Shi H, Zhou J, Ma C, Ji F, Wu Y, Zhao Y, Qian J, Wang X. Shexiang Baoxin Pill (MUSKARDIA) reduces major adverse cardiovascular events in women with stable coronary artery disease: A subgroup analysis of a phase IV randomized clinical trial. Front Cardiovasc Med. 2022 Oct 21;9:1002400. doi: 10.3389/fcvm.2022.1002400. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Title:\n\nA randomized, double-blind, multi-centered, placebo-controlled trial to examine effects of of Heart-protecting Musk Pill on clinical outcomes in patients with chronic stable coronary artery disease\n\nObjective:\n\nTo examine effects of of Heart-protecting Musk Pill, a traditional Chinese medicine, on clinical outcomes in patients with chronic stable coronary artery disease\n\nThe study hypothesis:\n\nThe null hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is the same as that in control group.\n\nThe alternative hypothesis: the combined incidence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke in the treatment group is different from that in control group.\n\nSample size:\n\n2700 patients will be randomized, 1350 in treatment group and 1350 in placebo group.\n\nNumber of sites: 99 sites in China\n\nStudy drugs:\n\nHeart-protecting Musk Pill and the matching placebo pills.\n\nDesign:\n\nA randomized, double-blind, multi-centered, placebo-controlled trial. Patients will be randomized to treatment group and placebo group after screening and get corresponding treatment as follow.\n\nTreatment group: Standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months.\n\nControl group: Standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months.\n\nPatients will be followed up at baseline, 1, 3, 6, 9, 12, 18, 24 months after randomization. During follow-up period, patients could undertake PCI or CABG if angina get out of control or evidence of ischemia aggravated is found.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age≥18 years at screening.\n2. Patients who have ischemia myocardial symptoms and whose clinical symptoms keep stable for at least one month.\n3. Have at least one of the following events (providing hospital records or inspection report): 1)history of acute myocardial infarction for at least half of a year; 2) history of PCI or CABG for at least half of a year; 3) coronary CT angiography or coronary angiography shows that at least one of the main branches of coronary artery stenosis is no less than 50%.\n4. Provide informed consent form.\n\nExclusion Criteria:\n\n1. History of acute myocardial infarction, vascular reconstruction, CABG or PCI within half of a year.\n2. Prepared to undertake CABG or PCI during this study.\n3. Serious cardiovascular diseases: sustained severe angina (CCS Ⅳ), refractory heart failure, cardiogenic shock, severe aortic stenosis or aortic insufficiency.\n4. Severe respiratory diseases;\n5. Diabetic patients with poor glycemic control (fasting blood glucose \\> 200 mg/dl or 11.1mmol/L for more than twice within one month before the study entry).\n6. Hypertensive patients with poor control of blood pressure, systolic pressure≥180mmHg or diastolic pressure≥110mmHg before entry.\n7. Severe liver and kidney diseases,such as active liver disease, cirrhosis and uremia.\n8. Any other severe diseases, such as malignant tumor, severe anemia and severe renal artery stenosis.\n9. Unable or unwilling to sign informed consent form.\n10. Join another trial or has received random allocation of this study within one month before entry.\n11. Pregnant or who were attempting to become pregnant.\n12. Patients who are regarded as not being suitable participants by the study investigators.'}, 'identificationModule': {'nctId': 'NCT01897805', 'briefTitle': 'A Trial to Evaluate Efficacy of Heart-protecting Musk Pill', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Hutchison Pharmaceuticals Limited'}, 'officialTitle': 'A Randomized, Double-blind, Multi-centered, Placebo-controlled Trial to Examine Effects of Heart-protecting Musk Pill on Clinical Outcome in Patients With Chronic Stable Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'TG0930BXW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Heart-protecting Musk Pill', 'description': 'Patients will get standard treatment for coronary artery disease plus 2 Heart-protecting Musk Pills each time, three times a day by mouth for 24 months', 'interventionNames': ['Drug: Heart-protecting Musk Pill']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients will get standard treatment for coronary artery disease plus 2 placebo pills each time, three times a day by mouth for 24 months', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Heart-protecting Musk Pill', 'type': 'DRUG', 'armGroupLabels': ['Heart-protecting Musk Pill']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'AnHui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '230000', 'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'The First Affiliated Hospital of Medical University Of Anhui', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '243000', 'city': 'Maanshan', 'state': 'Anhui', 'country': 'China', 'facility': 'MaAnShan Central Hospital'}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing An Zhen Hospital of the Capital University of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tongren Hospital Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Dongfang Hospital Affiliated to Beijing University of Chinese Medicine', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100000', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Navi General 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'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Henan University of TCM', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Henan University of TCM', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'facility': 'Taihe Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Hubei Provincial 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'state': 'Jiangsu', 'country': 'China', 'facility': "Northern JiangSu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '225000', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "YangZhou No. 1 People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Affiliated Hospital of JiangXi University of Traditional Chinese Medicine', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The First Hospital of NanChang', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'The Second Affiliated Hospital of NanChang University', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '160000', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 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