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Actively Recruiting
Researchers are evaluating the efficacy and safety of Yangxinshi tablets in patients with coronary heart disease complicated by cardiac dysfunction. This Phase 4 randomized controlled trial aims to determine whether adding Yangxinshi tablets to conventional treatment can reduce ischemic or heart failure-related clinical events, improve exercise tolerance, and enhance quality of life and mental health in these patients. The study includes 2708 patients aged 40 to 80 years with specific heart conditions and symptoms. Participants are randomly divided into two groups: one group receives conventional treatment plus Yangxinshi tablets (3 tablets, three times daily), while the control group receives only conventional treatment without additional tablets. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others aimed at improving outcomes and relieving symptoms. The treatment continues until the expected number of endpoint events occurs or the study ends. During the study, participants are monitored for ischemic events or heart failure-related clinical events, including death, stroke, myocardial infarction, and hospital readmissions. The average follow-up period is about three years. Researchers assess exercise tolerance, quality of life, and mental health, while monitoring safety and overall health status throughout the study.