Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

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).

Inclusion criteria

• 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.

Exclusion criteria

• 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.