Randomized Trial of Yangxinshi Tablets Added to Standard Treatment for Patients Aged 40-80 with Coronary Heart Disease and Cardiac Dysfunction

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Yangxinshi tablets in patients with coronary heart disease combined with cardiac dysfunction. This study aims to determine if adding Yangxinshi tablets to standard treatment can reduce heart-related events, enhance exercise capacity, and improve quality of life and mental health. The trial includes 2708 patients and is a Phase 4 randomized controlled study sponsored by SPH Qingdao Growful Pharmaceutical Co., Ltd. Participants are randomly assigned to one of two groups one group receives conventional treatment plus Yangxinshi tablets 3 tablets taken orally three times a day, while the control group receives conventional treatment alone. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others for symptom relief and improving heart outcomes. The treatment continues until a set number of heart-related events occur or the study ends. Throughout the study, participants undergo regular assessments including measurements of heart events, exercise tolerance, heart function tests, blood markers, and mental health questionnaires over an average of three years. Additional evaluations at 24 and 48 weeks include depression and anxiety scales, echocardiography, and exercise testing. The research team closely monitors safety, quality of life, and heart function throughout the study period.

Efficacy and Safety Trials of Yangxinshi Tablets in the Treatment of Patients With Coronary Heart Disease Complicated by Cardiac Dysfunction