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 ≥ 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
🇨🇳Zhengzhou, Henan, China
Binzhou Medical University Hospital
🇨🇳Binzhou, Shandong, China
Binzhou People's Hospital
🇨🇳Binzhou, Shandong, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Longkou People Hosptial
🇨🇳Longkou, Shandong, China
Hospital of Cardiovascular Diseases Affiliated to Qingdao University
🇨🇳Qingdao, Shandong, China
Shapingba District People's Hospital of Chongqing
🇨🇳Chongqing, Chongqing, China
Dezhou Municiple Hospital
🇨🇳Dezhou, Shandong, China
Feicheng People's Hospital
🇨🇳Feicheng, Shandong, China
Pingyuan County first People's Hospital
🇨🇳Dezhou, Shandong, China
Shandong Health Group Feicheng Hospital
🇨🇳Feicheng, Shandong, China
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
🇨🇳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
Linyi People's Hospital
🇨🇳Linyi, Shandong, China
The Second People's Hospital of Liaocheng
🇨🇳Liaocheng, Shandong, China
Linqing City People's Hospital
🇨🇳Linqing, Shandong, China
Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Qingdao Fuwai Hospital
🇨🇳Qingdao, Shandong, China
Qingdao Central Hospital
🇨🇳Qingdao, Shandong, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
Shandong University Qilu Hospital Qingdao District
🇨🇳Qingdao, Shandong, China
Xintai People's Hospital
🇨🇳Taian, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
🇨🇳Taian, Shandong, China
Weifang City People's Hospital
🇨🇳Weifang, Shandong, China
Tengzhou Central People's Hospital
🇨🇳Tengzhou, Shandong, China
Weifang City Yidu Central Hospital
🇨🇳Weifang, Shandong, China
Yantai Hospital of Traditional Chinese Medicine
🇨🇳Yantai, Shandong, China