Abstract
BackgroundCardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Naoxintong (NXT) capsule is a classical traditional Chinese medication used to treat CSA, however, few evidence to support the wide utility of NXT capsule for the treatment of CSA. We design this study to evaluate the efficacy and safety of NXT capsule versus placebo in patients with CSA.Methods/designThis is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 260 eligible participants will be enrolled. The participants will be randomized assigned in an equal ratio to groups receiving either NXT or placebo for 12 weeks. After a 2-week run-in period, they will receive either NXT or placebo (3 pills, 3 times daily) for 12 weeks. The primary outcome is therapeutic efficacy. Secondary outcome measures include the quantitative score of TCM syndromes, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of Seattle angina scale, serum homocysteine, and incidence of cardiovascular events. Safety outcomes and adverse events will be monitored throughout the trial.DiscussionWe designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide clinical evidence of the efficacy and safety of NXT Capsule in the treatment of CSA.Trial registrationChinese Clinical Trial Registry ChiCTR2100044563. Registered on 24 March 2020.
Highlights
Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction
We designed this study in accordance with principles and regulations issued by the China Food and Drug Administration (CFDA)
This study is a randomized, double-blind, placebocontrolled trial designed for NXT capsule to evaluate the efficacy and safety in the treatment of CSA
Summary
Cardiovascular disease is the leading cause of mortality and morbidity worldwide, Chronic stable angina (CSA) is the main symptom of myocardial ischemia, causes increased risk of major cardiovascular events such as sudden cardiac death and myocardial infarction. Cardiovascular disease, despite many advances in its diagnosis and treatment, remains the leading cause of morbidity and mortality worldwide, leading to over 17.3 million deaths per year and perhaps growing to over 23.6 million deaths per year by 2030 [1, 2]. CSA is a major symptomatic presentation in about 50% of patients with coronary heart disease (CHD). The goals of treating CSA are to improve quality of life and minimize the risk of cardiovascular events [6]. Lifestyle changes, such as maintaining a healthy weight, consuming a low-fat diet, Huanjia et al Trials (2021) 22:336 discontinuing the use of tobacco products, and finding ways to reduce stress are encouraged [7]
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