Yangxinshi tablets for improving exercise capacity in chronic coronary syndrome patients
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial
This study is testing if adding Yangxinshi tablets to standard treatment can help people with chronic coronary syndrome walk farther and improve their exercise ability.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shandong First Medical University Academic / other |
| Locations | 32 sites (Chongqing, Chongqing Municipality and 31 other locations) |
| Trial ID | NCT06171061 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Yangxinshi tablets in patients with chronic coronary syndrome (CCS). It is a multicenter, randomized, open-label trial involving 1200 participants, where patients will be assigned to either an experimental group receiving Yangxinshi tablets alongside basic medication or a control group receiving only basic medication. The treatment duration is 24 weeks, and the primary outcome measure is the 6-minute walking distance (6MWD). The study aims to determine if the addition of Yangxinshi tablets can enhance exercise capacity in CCS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with stable chronic coronary syndrome and limited exercise tolerance.
Not a fit: Patients with serious primary diseases, mental health issues, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve exercise capacity and quality of life for patients with chronic coronary syndrome.
How similar studies have performed: Other studies have shown promising results with similar interventions, suggesting potential efficacy for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chongqing, Chongqing Municipality and 31 other locations
- Shapingba District People's Hospital of Chongqing — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
- Zhengzhou Seventh People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
- Binzhou Medical University Hospital — Binzhou, Shandong, China (Not_yet_recruiting)
- Binzhou People's Hospital — Binzhou, Shandong, China (Not_yet_recruiting)
- Dezhou Municiple Hospital — Dezhou, Shandong, China (Not_yet_recruiting)
- Pingyuan County first People's Hospital — Dezhou, Shandong, China (Not_yet_recruiting)
- Feicheng People's Hospital — Feicheng, Shandong, China (Recruiting)
- Shandong Health Group Feicheng Hospital — Feicheng, Shandong, China (Recruiting)
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong, China (Recruiting)
- Jinan Central Hospital — Jinan, Shandong, China (Not_yet_recruiting)
- Jinan Zhangqiu District People's Hospital — Jinan, Shandong, China (Not_yet_recruiting)
- Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
- The Fourth People's Hospital of Jinan — Jinan, Shandong, China (Not_yet_recruiting)
- Gaotang County People's Hospital — Liaocheng, Shandong, China (Not_yet_recruiting)
- Liaocheng Hospital of Traditional Chinese Medicine — Liaocheng, Shandong, China (Not_yet_recruiting)
- Liaocheng People's Hospital — Liaocheng, Shandong, China (Not_yet_recruiting)
- The Second People's Hospital of Liaocheng — Liaocheng, Shandong, China (Not_yet_recruiting)
- Linqing City People's Hospital — Linqing, Shandong, China (Not_yet_recruiting)
- Linyi People's Hospital — Linyi, Shandong, China (Not_yet_recruiting)
- Longkou People Hosptial — Longkou, Shandong, China (Not_yet_recruiting)
- Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (Recruiting)
- Hospital of Cardiovascular Diseases Affiliated to Qingdao University — Qingdao, Shandong, China (Recruiting)
- Qingdao Central Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
- Qingdao Fuwai Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
- Qingdao Municipal Hospital — Qingdao, Shandong, China (Not_yet_recruiting)
- Shandong University Qilu Hospital Qingdao District — Qingdao, Shandong, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Shandong First Medical University — Taian, Shandong, China (Not_yet_recruiting)
- Xintai People's Hospital — Taian, Shandong, China (Not_yet_recruiting)
- Tengzhou Central People's Hospital — Tengzhou, Shandong, China (Not_yet_recruiting)
- Weifang City People's Hospital — Weifang, Shandong, China (Not_yet_recruiting)
- Weifang City Yidu Central Hospital — Weifang, Shandong, China (Not_yet_recruiting)
- Yantai Hospital of Traditional Chinese Medicine — Yantai, Shandong, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Yuan Haitao — Shandong Provincial Hospital
- Study coordinator: Yuan Haitao
- Email: doctoryuanht@126.com
- Phone: 0531-68776356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.