Chronic Coronary Syndrome Clinical Trial
Official title:
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial
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).
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. age 18-75 years; 2. 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; 3. 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; 4. voluntary participation and signing of informed consent. Exclusion Criteria: 1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT); 2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan; 3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months; 4. 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. |
Country | Name | City | State |
---|---|---|---|
China | Binzhou Medical University Hospital | Binzhou | Shandong |
China | Binzhou People's Hospital | Binzhou | Shandong |
China | Shapingba District People's Hospital of Chongqing | Chongqing | Chongqing |
China | Dezhou Municiple Hospital | Dezhou | Shandong |
China | Pingyuan County first People's Hospital | Dezhou | Shandong |
China | Feicheng People's Hospital | Feicheng | Shandong |
China | Shandong Health Group Feicheng Hospital | Feicheng | Shandong |
China | Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Jinan | Shandong |
China | Jinan Central Hospital | Jinan | Shandong |
China | Jinan Zhangqiu District People's Hospital | Jinan | Shandong |
China | Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong |
China | The Fourth People's Hospital of Jinan | Jinan | Shandong |
China | Gaotang County People's Hospital | Liaocheng | Shandong |
China | Liaocheng Hospital of Traditional Chinese Medicine | Liaocheng | Shandong |
China | Liaocheng People's Hospital | Liaocheng | Shandong |
China | The Second People's Hospital of Liaocheng | Liaocheng | Shandong |
China | Linqing City People's Hospital | Linqing | Shandong |
China | Linyi People's Hospital | Linyi | Shandong |
China | Longkou People Hosptial | Longkou | Shandong |
China | Affiliated Hospital of Qingdao University | Qingdao | Shandong |
China | Hospital of Cardiovascular Diseases Affiliated to Qingdao University | Qingdao | Shandong |
China | Qingdao Central Hospital | Qingdao | Shandong |
China | Qingdao Fuwai Hospital | Qingdao | Shandong |
China | Qingdao Municipal Hospital | Qingdao | Shandong |
China | Shandong University Qilu Hospital Qingdao District | Qingdao | Shandong |
China | The Second Affiliated Hospital of Shandong First Medical University | Taian | Shandong |
China | Xintai People's Hospital | Taian | Shandong |
China | Tengzhou Central People's Hospital | Tengzhou | Shandong |
China | Weifang City People's Hospital | Weifang | Shandong |
China | Weifang City Yidu Central Hospital | Weifang | Shandong |
China | Yantai Hospital of Traditional Chinese Medicine | Yantai | Shandong |
China | Zhengzhou Seventh People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Shandong First Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 6MWD | The 6-min walking distance | 24 weeks after treatment | |
Secondary | Borg scale | score range: 0~10,higher scores mean a worse outcome. | 24 weeks after treatment | |
Secondary | MACCE | incidence of major adverse cardiovascular and cerebrovascular events (MACCE) | after 4, 8, 12, 16, 20, and 24 weeks of treatment |
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