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- 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.
- Authors
Shengyao Li; Ming Guo; Huimin Mao; Zhuye Gao; Hao Xu; Dazhuo Shi; Li, Shengyao; Guo, Ming; Mao, Huimin; Gao, Zhuye; Xu, Hao; Shi, Dazhuo
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>The trial was registered in the Chinese Clinical Trial Registry on December 28, 2013. The registration number is ChiCTR-TRC-13004370 .
- Subjects
CHINA; CORONARY heart disease treatment; CHINESE medicine; RANDOMIZED controlled trials; ADVERSE health care events; ACUTE coronary syndrome; HEART failure; VENTRICULAR arrhythmia; MYOCARDIAL infarction diagnosis; MYOCARDIAL infarction-related mortality; MYOCARDIAL infarction treatment; CARDIOVASCULAR agents; COMBINATION drug therapy; COMPARATIVE studies; CORONARY disease; EXPERIMENTAL design; HERBAL medicine; RESEARCH methodology; MEDICAL cooperation; RESEARCH protocols; MYOCARDIAL revascularization; RESEARCH; TIME; EVALUATION research; TREATMENT effectiveness; BLIND experiment; DISEASE progression; PATIENT readmissions; DIAGNOSIS; THERAPEUTICS
- Publication
Trials, 2016, Vol 17, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-016-1569-9