Xuesaitong Capsule For Patients After Percutaneous Coronary Intervention For Unstable Angina: Study Protocol For a Randomized Controlled Trial

Abstract • Background: This study was designed to investigate the effect of Xuesaitong (XST) capsule added to conventional treatment in patients after percutaneous coronary intervention (PCI) for unstable angina (UA).• Methods: This is a 12-week, randomized, multi-center, double-blinded, placebo-controlled clinical trial. A total of 120 patients with UA will be recruited and randomly allocated in a 1:1 ratio to receive XST or placebo (2 capsules twice per day) on the background of conventional treatment. The changed level of high-sensitivity C-reactive protein from baseline to week 12 is the primary outcome. Secondary outcomes include tumor necrosis factor-α, interleukin-6, platelet aggregation, blood lipid, angina symptoms and ST segment deviation in electrocardiogram. The safety of XST will be monitored during the trial.• Discussion: This study will provide an evidence regarding the efficacy and safety of XST on the background of conventional medical treatment in patients after PCI for UA.• Trial registration: Chinese Clinical Trial Registry, ChiCTR2000032152. Registered on 14 January 2020.