title: Effect of Xinyue capsules on patients with coronary heart disease after percutaneous coronary intervention: study protocol for a randomized controlled trial.
abstract: The 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.
  
  
  
  This 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.
  
  
  
  The 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.
  
  
  
  Chinese Clinical Trials Registry identifier ChiCTR-IPR-14005475. Registered on 10 November 2014.
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Guo
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.
authors.forename: Ming-Jie
authors.initials: MJ
authors.lastname: Zi
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.|Department of Medicine, Jilin Jilin Yisheng Pharmaceutical Co., Ltd., 17 Wen Hua Dong Lu Road, Ji'an, 134200, China.
authors.forename: Rui-Xi
authors.initials: RX
authors.lastname: Xi
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.
authors.forename: Qiao-Ning
authors.initials: QN
authors.lastname: Yang
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.
authors.forename: Rui-Na
authors.initials: RN
authors.lastname: Bai
authors.affiliation: Department of Medicine, Jilin Jilin Yisheng Pharmaceutical Co., Ltd., 17 Wen Hua Dong Lu Road, Ji'an, 134200, China.
authors.forename: Yi-Sheng
authors.initials: YS
authors.lastname: Zhang
authors.affiliation: Department of Medicine, Jilin Jilin Yisheng Pharmaceutical Co., Ltd., 17 Wen Hua Dong Lu Road, Ji'an, 134200, China.
authors.forename: Yu-Hua
authors.initials: YH
authors.lastname: Wang
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China. 191593690@qq.com.
authors.forename: Pei-Li
authors.initials: PL
authors.lastname: Wang
authors.affiliation: Cardiovascular Diseases Center, Xiyuan Hospital, China Academy of Chinese Medical Sciences, 1 Xiyuan Caochang, Haidian District, Beijing, 100091, China.
authors.forename: Da-Zhuo
authors.initials: DZ
authors.lastname: Shi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002214:Capsules; D003327:Coronary Disease / Q000601:surgery*; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000517:prevention & control*; D062645:Percutaneous Coronary Intervention; D012503:Saponins / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D013997:Time Factors
chemical_list: D002214:Capsules; D004365:Drugs, Chinese Herbal; C079995:Panax quinquefolium saponin; D012503:Saponins
keywords: Coronary heart disease; Randomized controlled trial; Xinyue capsule