The design of TXL-CAP study: a randomized, double-blind, placebo-controlled, multicenter Clinical Trial to assess Tongxinluo Capsule on Coronary Atherosclerotic Vulnerable Plaque

Abstract Background Traditional Chinese medicine (TCM) Tongxinluo (TXL) capsules have been widely used in atherosclerosis treatment. Previous studies have demonstrated the TXL can retard the progression of atherosclerosis and reduce the incidence of cardiovascular events. In the present study (TXL-CAP trial), we aim to evaluate the efficacy of TXL on non-ST elevation acute coronary syndrome (NSTE-ACS) treatment. Methods This study is a randomized, double-blind, placebo-controlled, parallel-grouped multicenter clinical study and 220 patients diagnosed with NSTE-ACS will be enrolled. Patients will be randomized 1:1 to receive the TXL or placebo in addition to their standard treatment. The primary end point is the difference in the thickness of the fibrous cap of the target coronary artery plaque evaluated by OCT. The secondary observation indicators included the incidence of major adverse cardiovascular events (MACE), the proportion of patients with improved angina pectoris, Seattle angina pectoris questionnaire score, and serum levels of inflammatory cytokines (IL-1 β, IL-18, TNF- α). Conclusion The results of the TXL-CAP trial will provide clinical data for revealing whether TXL capsules stabilize vulnerable plaques in Chinese NSTE-ACS patients. Trial registration: The trial was registered at the Chinese Clinical Trial Registry on September 10, 2019 (http://www.chictr.org.cn). The registration Number was ChiCTR1900025842.