Assessing the clinical outcomes of dazhu hongjingtian injection for the management of stable and unstable angina: protocol for a prospective observational study

Abstract

Background: The global rise in angina pectoris, a symptom of coronary artery disease, is primarily attributed to an aging population and increasing prevalence of comorbidities. This study aims to assess the efficacy and safety of Dazhu Hongjingtian injection (DZHJTI) as an adjunct treatment for both stable and unstable angina, thereby addressing a significant gap in current cardiac care research. Methods: This comprehensive study involves two parallel prospective cohorts across 28 medical centers in China, enrolling 1,500 patients with stable angina and 2,000 with unstable angina. Participants are randomized into two groups: one receiving the DZHJTI alongside standard therapy, and the other receiving standard therapy alone. The study employs advanced statistical methods like Subgroup Analysis and Marginal Mean Weighting Through Stratification to analyze data accurately. Discussion: The primary outcome of this study is the reduction in the frequency of angina attacks post-treatment. Secondary outcomes include evaluation of patient wellbeing through clinical measures such as nitrate dosage requirements, vital sign stability, electrocardiogram changes, and laboratory data. Patient-reported outcomes from targeted questionnaires will also be assessed to understand the impact on quality of life. The study’s results are expected to contribute significantly to the understanding of DZHJTI’s role in treating angina pectoris, potentially influencing future treatment guidelines.