Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study protocol for a randomized controlled trial

Abstract

BackgroundThe risk of cardiovascular events remains high in patients with coronary heart disease (CHD) after successful percutaneous coronary intervention (PCI). Panax quinquefolius saponin, a major component of Xinyue capsule, has been used to treat patients with CHD. The aim of this study is to evaluate the efficacy and safety of Xinyue capsules in patients with CHD after PCI.Methods/designThis study is a multicenter, placebo-controlled, double-blind, randomized controlled clinical trial. A total of 1100 participants are randomly allocated to two groups: the intervention group and a placebo group. The intervention group receives Xinyue capsules plus conventional treatment, and the placebo group receives placebo capsules plus conventional treatment. The patients receive either Xinyue or placebo capsules three times daily (1.8 g/day) for up to 24 weeks. The primary outcome measure is the time from randomization to the first occurrence of major adverse cardiovascular events. The secondary outcome measure is the time from randomization to the first occurrence of stroke, pulmonary embolism, and peripheral vascular events, as well as death due to any cause. All outcome measures will be assessed at 12, 24, 36, and 48 weeks after randomization. Adverse events will be monitored during the trial.DiscussionThe aim of this study is to evaluate the effects of Xinyue capsules on patients with CHD after interventional treatment. The results of this trial will provide critical evidence regarding Chinese herbal medicine treatment for CHD.Trial registrationChinese Clinical Trials Registry identifier ChiCTR-IPR-14005475. Registered on 10 November 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1531-x) contains supplementary material, which is available to authorized users.

Panax quinquefolius L. Saponins Protect Myocardial Ischemia Reperfusion No-Reflow Through Inhibiting the Activation of NLRP3 Inflammasome via TLR4/MyD88/NF-κB Signaling Pathway

“…NLRP3 inflammasome is a multi-protein complex located in the cytoplasm, which is composed of NOD-like receptor protein 3 (NLRP3), apoptosis-related dot-like protein (ASC), and cysteine aspartase-1 precursor (Procaspase-1). Evidence was given that assembling and activation of NLRP3 inflammasome occurred at the most stages of MI/R process and then sequentially modulated the occurrence of downstream inflammatory factors, IL-1β and IL-18 ( Guo et al, 2016 ). In the present study, our results showed that, with the occurrence of NR phenomenon, NLRP3 inflammasome was obviously activated, and pretreatment of PQS significantly inhibited the expression of NLRP3, ASC, and caspase-1.…”

Panax quinquefolius saponins combined with dual antiplatelet drug therapy alleviate gastric mucosal injury and thrombogenesis through the COX/PG pathway in a rat model of acute myocardial infarction

“…Xinyue capsules ( Panax quinquefolium saponins) contain stem and leaf extracts of American ginseng, and especially the saponins, including G-Rd, G-Rb 2 , G-Rb 3 , and P-F 1 . Xinyue capsules have been used to treat coronary heart disease for the past 20 years, and may effectively reduce the risk of angina and alleviate the patient’s clinical symptoms [ 8 – 9 ]. Our previous study confirmed that Panax quinquefolius Saponins (PQS) in combination with DAPT (PQS+DAPT) improved ventricular reconstruction in rats with acute myocardial infarction (AMI) rats and reduced gastric mucosa injury compared with DAPT alone [ 10 ].…”