Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome: Prospective, Multicentre, Randomized, Open-label, Blinded-endpoint Clinical Trial
Shandong First Medical University
1,200 participants
Dec 18, 2023
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria4
- 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 Criteria4
- 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.
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Interventions
In 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.
The control group will be given basic medication only. The treatment period is 24 weeks.
Locations(32)
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NCT06171061