title: Qing-Xin-Jie-Yu Granules in addition to conventional treatment for patients with stable coronary artery disease (QUEST Trial): study protocol for a randomized controlled trial.
abstract: Recurrent cardiovascular event remains high in stable coronary artery disease (SCAD), especially in patients with multiple risk factors, despite a high rate of use conventional treatment. Traditional Chinese Medicine (TCM) is a promising complementary and alternative medicine for treating SCAD, while evidence for its effect on long-term survival is limited. This study was designed to test if Chinese herbal medicine in addition to conventional treatment is more effective than conventional treatment alone in reducing major adverse cardiac event (MACE) for SCAD patients with multiple risk factors during a 1-year follow-up.
  
  
  
  This is a multicenter, placebo-controlled, double-blinded, randomized controlled clinical trial. A total of 1500 patients are randomized in a 1:1 ratio to receive the Qing-Xin-Jie-Yu Granules (QXJYG) or the placebo granules, twice daily for 6 months. The primary outcome is the combined outcomes including cardiac death, nonfatal myocardial infarction and revascularization. The secondary outcome is the combined outcomes including all-cause mortality, re-admission for acute coronary syndrome (ACS), heart failure, malignant supraventricular and ventricular arrhythmia influencing hemodynamics, ischemic stroke, and other thromboembolic events during 1-year follow-up. The assessment is performed at baseline (before randomization), 1, 3, 6, 9, and 12 months after randomization.
  
  
  
  This is the first multicenter trial sponsored by the national funding of China to evaluate TCM in combination with conventional treatment on 1-year survival in high-risk SCAD patients. If successful, it will provide an evidence-based complementary therapeutic approach for reducing MACE from SCAD.
  
  
  
  The trial was registered in the Chinese Clinical Trial Registry on December 28, 2013. The registration number is ChiCTR-TRC-13004370 .
authors.affiliation: Department of Cardiology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China.|Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Shengyao
authors.initials: S
authors.lastname: Li
authors.affiliation: Department of Cardiology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China.|Graduate School, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Guo
authors.affiliation: Department of Cardiology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China.|Graduate School, Beijing University of Chinese Medicine, Beijing, 100029, China.
authors.forename: Huimin
authors.initials: H
authors.lastname: Mao
authors.affiliation: Department of Cardiology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China.
authors.forename: Zhuye
authors.initials: Z
authors.lastname: Gao
authors.affiliation: Department of Cardiology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China. xuhaotcm@hotmail.com.
authors.forename: Hao
authors.initials: H
authors.lastname: Xu
authors.affiliation: Department of Cardiology, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China. shidazhuo@126.com.
authors.forename: Dazhuo
authors.initials: D
authors.lastname: Shi
mesh_terms: D002317:Cardiovascular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D002985:Clinical Protocols; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D009203:Myocardial Infarction / Q000175:diagnosis / Q000401:mortality / Q000628:therapy; D009204:Myocardial Revascularization; D010359:Patient Readmission; D012107:Research Design; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D004365:Drugs, Chinese Herbal; C000626150:qing-xin-jie-yu granules
keywords: Chinese herbal medicine; Inflammation; Qing-Xin-Jie-Yu Granules; Randomized controlled trial; Stable coronary artery disease