About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Yangxinshi tablet
DrugIn addition to basic medication, the experimental group will be given Yangxinshi (three tablets each time, three times a day);The treatment period is 24 weeks.
Basic medication
Other interventionThe control group will be given basic medication only. The treatment period is 24 weeks.
Treatment groups
Trial outcomes
Primary outcomes
6MWD
The 6-min walking distance
Secondary outcomes
Borg scale
score range: 0\~10,higher scores mean a worse outcome.
MACCE
incidence of major adverse cardiovascular and cerebrovascular events (MACCE)
Sponsors and contacts
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