Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
- Conditions
- Chronic Coronary Syndrome
- Interventions
- Drug: Yangxinshi tabletOther: Basic medication
- Registration Number
- NCT06171061
- Lead Sponsor
- Shandong First Medical University
- Brief Summary
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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1200
- age 18-75 years;
- CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis β₯ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or >3 months after coronary revascularization;
- 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;
- voluntary participation and signing of informed consent.
- absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);
- serious primary diseases, mental diseases, or malignant tumours that affect lifespan;
- pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Yangxinshi tablet basic medication + Yangxinshi tablet Control group Basic medication basic medication.
- Primary Outcome Measures
Name Time Method 6MWD 24 weeks after treatment The 6-min walking distance
- Secondary Outcome Measures
Name Time Method MACCE after 4, 8, 12, 16, 20, and 24 weeks of treatment incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Borg scale 24 weeks after treatment score range: 0\~10,higher scores mean a worse outcome.
Trial Locations
- Locations (32)
Zhengzhou Seventh People's Hospital
π¨π³Zhengzhou, Henan, China
Binzhou Medical University Hospital
π¨π³Binzhou, Shandong, China
Binzhou People's Hospital
π¨π³Binzhou, Shandong, China
Jinan Central Hospital
π¨π³Jinan, Shandong, China
Longkou People Hosptial
π¨π³Longkou, Shandong, China
Hospital of Cardiovascular Diseases Affiliated to Qingdao University
π¨π³Qingdao, Shandong, China
Shapingba District People's Hospital of Chongqing
π¨π³Chongqing, Chongqing, China
Dezhou Municiple Hospital
π¨π³Dezhou, Shandong, China
Feicheng People's Hospital
π¨π³Feicheng, Shandong, China
Pingyuan County first People's Hospital
π¨π³Dezhou, Shandong, China
Shandong Health Group Feicheng Hospital
π¨π³Feicheng, Shandong, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
π¨π³Jinan, Shandong, China
Jinan Zhangqiu District People's Hospital
π¨π³Jinan, Shandong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
π¨π³Jinan, Shandong, China
The Fourth People's Hospital of Jinan
π¨π³Jinan, Shandong, China
Gaotang County People's Hospital
π¨π³Liaocheng, Shandong, China
Liaocheng Hospital of Traditional Chinese Medicine
π¨π³Liaocheng, Shandong, China
Liaocheng People's Hospital
π¨π³Liaocheng, Shandong, China
Linyi People's Hospital
π¨π³Linyi, Shandong, China
The Second People's Hospital of Liaocheng
π¨π³Liaocheng, Shandong, China
Linqing City People's Hospital
π¨π³Linqing, Shandong, China
Affiliated Hospital of Qingdao University
π¨π³Qingdao, Shandong, China
Qingdao Fuwai Hospital
π¨π³Qingdao, Shandong, China
Qingdao Central Hospital
π¨π³Qingdao, Shandong, China
Qingdao Municipal Hospital
π¨π³Qingdao, Shandong, China
Shandong University Qilu Hospital Qingdao District
π¨π³Qingdao, Shandong, China
Xintai People's Hospital
π¨π³Taian, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
π¨π³Taian, Shandong, China
Weifang City People's Hospital
π¨π³Weifang, Shandong, China
Tengzhou Central People's Hospital
π¨π³Tengzhou, Shandong, China
Weifang City Yidu Central Hospital
π¨π³Weifang, Shandong, China
Yantai Hospital of Traditional Chinese Medicine
π¨π³Yantai, Shandong, China