Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT06171061
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628007', 'term': 'Yangxinshi'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-16', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6MWD', 'timeFrame': '24 weeks after treatment', 'description': 'The 6-min walking distance'}], 'secondaryOutcomes': [{'measure': 'Borg scale', 'timeFrame': '24 weeks after treatment', 'description': 'score range: 0\\~10,higher scores mean a worse outcome.'}, {'measure': 'MACCE', 'timeFrame': 'after 4, 8, 12, 16, 20, and 24 weeks of treatment', 'description': 'incidence of major adverse cardiovascular and cerebrovascular events (MACCE)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Yangxinshi', 'Chronic Coronary Syndrome'], 'conditions': ['Chronic Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).', 'detailedDescription': 'This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 18-75 years;\n2. CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or \\>3 months after coronary revascularization;\n3. moderately to severely limited exercise tolerance: the maximum 6MWD is \\< 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is \\< 5 METs;\n4. voluntary participation and signing of informed consent.\n\nExclusion Criteria:\n\n1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);\n2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan;\n3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;\n4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.'}, 'identificationModule': {'nctId': 'NCT06171061', 'briefTitle': 'Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Shandong First Medical University'}, 'officialTitle': 'Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial', 'orgStudyIdInfo': {'id': 'GrowfulPower-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'basic medication + Yangxinshi tablet', 'interventionNames': ['Drug: Yangxinshi tablet']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'basic medication.', 'interventionNames': ['Other: Basic medication']}], 'interventions': [{'name': 'Yangxinshi tablet', 'type': 'DRUG', 'otherNames': ['Yangxinshi'], 'description': 'In addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.', 'armGroupLabels': ['Experimental group']}, {'name': 'Basic medication', 'type': 'OTHER', 'description': 'The control group will be given basic medication only. The treatment period is 24 weeks.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Shapingba District People's Hospital of Chongqing", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Zhengzhou', 'state': 'Henan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Zhengzhou Seventh People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'city': 'Binzhou', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Binzhou Medical University Hospital', 'geoPoint': {'lat': 37.36667, 'lon': 118.01667}}, {'city': 'Binzhou', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Binzhou People's Hospital", 'geoPoint': {'lat': 37.36667, 'lon': 118.01667}}, {'city': 'Dezhou', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Dezhou Municiple Hospital', 'geoPoint': {'lat': 37.44661, 'lon': 116.36706}}, {'city': 'Dezhou', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Pingyuan County first People's Hospital", 'geoPoint': {'lat': 37.44661, 'lon': 116.36706}}, {'city': 'Feicheng', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': "Feicheng People's Hospital", 'geoPoint': {'lat': 35.26056, 'lon': 117.9675}}, {'city': 'Feicheng', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Shandong Health Group Feicheng Hospital', 'geoPoint': {'lat': 35.26056, 'lon': 117.9675}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lu Feng, Professor', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Shandong University of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Jinan Central Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Jinan Zhangqiu District People's Hospital", 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuan Haitao, Professor', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Hospital Affiliated to Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Jinan', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The Fourth People's Hospital of Jinan", 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Liaocheng', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Gaotang County People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'city': 'Liaocheng', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Liaocheng Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'city': 'Liaocheng', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Liaocheng People's Hospital", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'city': 'Liaocheng', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "The Second People's Hospital of Liaocheng", 'geoPoint': {'lat': 36.45064, 'lon': 116.00247}}, {'city': 'Linqing', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Linqing City People's Hospital", 'geoPoint': {'lat': 36.84092, 'lon': 115.71087}}, {'city': 'Linyi', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Linyi People's Hospital", 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'city': 'Longkou', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Longkou People Hosptial', 'geoPoint': {'lat': 37.65181, 'lon': 120.33063}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Hospital of Cardiovascular Diseases Affiliated to Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Qingdao Central Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Qingdao Fuwai Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Qingdao Municipal Hospital', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Qingdao', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Shandong University Qilu Hospital Qingdao District', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'city': 'Taian', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Shandong First Medical University'}, {'city': 'Taian', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Xintai People's Hospital"}, {'city': 'Tengzhou', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Tengzhou Central People's Hospital", 'geoPoint': {'lat': 35.08357, 'lon': 117.19071}}, {'city': 'Weifang', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Weifang City People's Hospital", 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'city': 'Weifang', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Weifang City Yidu Central Hospital', 'geoPoint': {'lat': 36.71, 'lon': 119.10194}}, {'city': 'Yantai', 'state': 'Shandong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Yantai Hospital of Traditional Chinese Medicine', 'geoPoint': {'lat': 37.47649, 'lon': 121.44081}}], 'centralContacts': [{'name': 'Yuan Haitao', 'role': 'CONTACT', 'email': 'doctoryuanht@126.com', 'phone': '0531-68776356'}], 'overallOfficials': [{'name': 'Yuan Haitao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shandong Provincial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong First Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}