Efficacy and Safety of Naoxintong Capsule in Reducing Major Adverse Cardiovascular Events in Patients with Acute Coronary Syndrome: A Protocol for a Pragmatic Randomized Controlled Trial (Preprint)

UNSTRUCTURED Introduction: Acute coronary syndrome (ACS) remains a leading cause of mortality and morbidity worldwide, with substantial rates of major adverse cardiovascular events (MACE) despite guideline-directed medical therapy. Naoxintong Capsule (NXT), a Chinese patent medicine containing 16 herbs, has demonstrated potential cardiovascular benefits in preliminary studies. However, robust evidence for its effect on long-term clinical outcomes is lacking. Methods and Analysis: This pragmatic, multi-center, randomized controlled trial will evaluate the efficacy and safety of NXT in reducing MACE among ACS patients. We will recruit 410 patients from 10 Chinese hospitals and randomize them 1:1 to receive either NXT plus standard therapy or placebo plus standard therapy for 12 months, with 24-month follow-up. The primary outcome is MACE incidence, defined as a composite of cardiac death, myocardial infarction, heart failure, malignant arrhythmia, ischemic stroke, and coronary revascularization. Secondary outcomes include clinical efficacy measures, quality of life assessments (Seattle Angina Questionnaire, 6-minute walk test), and Traditional Chinese Medicine syndrome scores. This protocol adheres to SPIRIT guidelines. Discussion: This trial will provide high-quality evidence regarding NXT as adjunctive therapy for ACS. The pragmatic design enhances clinical applicability. If effective, NXT could offer a complementary approach to reducing cardiovascular events in ACS patients.