Yangxinshi tablet's effect on exercise tolerance in chronic coronary syndrome patients

Efficacy and Safety of Yangxinshi Tablet in Improving Exercise Tolerance in Patients With Chronic Coronary Syndrome(Qi Deficiency and Blood Stasis Syndrome):A Randomized, Double-blind,Placebo-parallel-controlled,Multicenter Clinical Study

This study is testing if adding Yangxinshi tablets to regular treatment can help people with chronic coronary syndrome exercise better and improve their overall well-being.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Dongzhimen Hospital, Beijing (Academic / other)
• Locations: 6 sites (Beijing, Beijing and 5 other locations)
• Trial ID: NCT05978089 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether Yangxinshi tablets can enhance exercise tolerance in patients diagnosed with chronic coronary syndrome (CCS) when added to conventional treatment. The study employs a randomized, double-blind, placebo-controlled design involving 120 participants, who are divided into two groups: one receiving Yangxinshi tablets and the other receiving a placebo. Over a treatment period of 24 weeks, the primary outcomes measured will include metabolic equivalents (METs) and peak oxygen uptake through cardiopulmonary exercise testing. The goal is to assess improvements in exercise capacity, quality of life, and mental health for those with CCS.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stable coronary heart disease and specific diagnostic criteria for chronic coronary syndrome.

Not a fit: Patients with severe leg pain, lower extremity dysfunction, or recent acute coronary syndrome may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve exercise tolerance and overall quality of life for patients with chronic coronary syndrome.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in enhancing exercise tolerance in patients with cardiovascular conditions.

Eligibility criteria

Inclusion Criteria:

All the following criteria must be met to participate in the study:

1. Meet the diagnostic criteria for CCS in Western medicine; stable coronary heart disease (CHD) with a degree of coronary stenosis ≥50% by angiography or computed tomography angiography (CTA) (including patients with more than 1 year of revascularization)
2. Meet the TCM standard of Qi deficiency and blood stasis syndrome
3. MET \< 5 measured by cardiopulmonary exercise test (treadmill)
4. Age between 18 and 75 years (including both age limits), with no limitation on sex
5. Understanding and voluntarily signing the written informed consent

Exclusion Criteria:

All the following criteria must not be met to participate in the study:

1. Individuals with lower extremity dysfunction, intermittent claudication or severe leg pain who cannot participate in cardiopulmonary exercise tests
2. Individuals with acute coronary syndrome within 1 month after percutaneous coronary intervention (PCI) or within 3 months after coronary artery bypass grafting (CABG)
3. Individuals with serious primary diseases related to the liver, kidney, and hematopoietic system, acute infectious diseases, and mental illness and individuals with other diseases who are not suitable for cardiopulmonary exercise tests
4. Individuals with a revascularization plan within a month
5. Individuals with left main stenosis ≥50% or proximal left anterior descending (LAD) diameter stenosis ≥90% without PCI or CABG
6. Individuals with absolute and relative contraindications to cardiopulmonary exercise testing (please see Appendix 11 for details)
7. Individuals with New York Heart Association (NYHA) cardiac function class III and IV
8. Individuals with acute cerebrovascular disease
9. Individuals with uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg
10. Individuals found to be in a state of severe anxiety and depression as determined using the GAD-7 and PHQ-9
11. Individuals with allergies or abnormal drug reactions to the test drugs
12. Women of childbearing age who are pregnant or breastfeeding, plan to get pregnant within six months, have a positive pregnancy test, and cannot take effective contraceptive measures during the study period
13. Individuals who have regularly taken YTs, Chinese herbal decoctions or proprietary Chinese medicines with similar curative effects within the past 7 days (please refer to Appendix 12 for the names of proprietary Chinese medicines)
14. Individuals who have participated in other clinical trials within the past 3 months
15. Individuals unsuitable for the clinical trials, as determined by the researchers

Where this trial is running

Beijing, Beijing and 5 other locations

• China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)
• Dongzhimen Hospital Beijing University of Chinese Medicine — Beijing, Beijing, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Not_yet_recruiting)
• Guangdong Provincial Hospital of Chinese Medicine — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)
• The First Affiliated Hospital of Henan University of CM — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Wang Xian — Dongzhimen Hospital, Beijing
• Study coordinator: Wang Xian

Conditions Chronic Coronary Syndrome; Cardiopulmonary Exercise Test; Yangxinshi