Effect of Xuesaitong Soft Capsules on Major Risk Factors in Patients With Coronary Heart Disease: a Multicenter, Randomized, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- hsCRP
研究概览
简要总结
This trials aims to assess, in 240 eligible patients with coronary heart disease, the effects on level of high-sensitivity C-reactive protein (hsCRP) changes from baseline to 12 weeks of Xuesaitong Soft Capsules.
详细描述
In this multicenter, randomized, double-blind, placebo-controlled trial in patients with coronary heart disease,240 eligible patients aged ≥18 years will be randomized to receive placebo or Xuesaitong Soft Capsules(1.32g/d) and be followed up for 3 months. The primary endpoint of this study is hsCRP change from baseline to 3 months. The secondary endpoint is the changes of following indicators or scores from baseline to 3 months:(Ⅰ)other inflammation indicators except for hsCRP. (Ⅱ) inhibition of platelet aggregation; (Ⅲ)endothelial function indicators; (Ⅳ)blood lipid levels; (Ⅴ) seattle angina questionnaire score; (Ⅵ)36-item short form health survey score. The safety of using Xuesaitong soft capsules in patients with coronary heart disease will also be evaluated. The generalized linear mixed effects model will be used to evaluate the efficacy endpoint for the "full analysis set". For the safety analysis set, Chi-square test will be used to evaluate the safety endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old
- •Chronic coronary artery disease: meet any of the following conditions, and the condition is stable for at least 3 months:
- •History of myocardial infarction
- •Have received coronary interventional therapy
- •There are symptoms of myocardial ischemia (such as chest pain) and objective evidence (stress electrocardiogram or stress myocardial perfusion imaging indicated myocardial ischemia or coronary artery stenosis ≥50% )
- •High-sensitivity C-reactive protein ≥2mg/L
- •Currently taking moderate or above intensity statins lipid-lowering drugs
- •Currently taking antiplatelet drugs
- •Sign informed consent
排除标准
- •Patients fulfilling any of the following criteria are not eligible for inclusion in this trial:
- •Acute coronary syndrome occurred or received percutaneous coronary intervention therapy within the past 3 months
- •Previously received coronary artery bypass grafting
- •Stroke occurred within the previous 3 months
- •Symptomatic heart failure (HF) in the past, or documented left ventricular ejection fraction < 35%
- •Revascularization or surgical procedures are planned within the next 3 months
- •Progressive neuromuscular disease, or creatine kinase (CK) levels > 3 times the normal upper limit (ULN)
- •Lupus, inflammatory bowel disease, severe arthritis and other inflammatory diseases
- •Immunosuppressants such as cyclosporine, tacrolimus, azathioprine, or systemic steroids are currently being taken or planned during the study
- •History of hereditary dyslipidemia such as familial hypercholesterolemia
- •There has been a change in lipid regulation treatment within the past 1 month, or there is a current adjustment plan
- •History of symptomatic non-traumatic cerebral hemorrhage at any time in the past
- •History of gastrointestinal bleeding or major surgery within the past 6 months
- •Use of Xuesaitong soft capsules or preparations containing the main ingredients of Xuesaitong in the past 1 month
- •There were clear adverse reactions to the main components of Xuesaitong in the past
- •Active liver disease, or alanine aminotransferase (ALT) levels > 3 times the upper limit of normal (ULN)
- •Chronic kidney disease, or estimated glomerular filtration rate (eGFR) <60ml/ (min×1.73m2)
- •Pregnancy or planned pregnancy, or breastfeeding
- •Malignant tumors, or other serious diseases with an estimated survival of less than 1 year
- •Mental disorders or communication disorders, cognitive impairment, or other serious medical conditions that may affect study participation
- •Have participated in or are participating in other clinical trials within the last 1 month
- •Poor adherence to follow-up or medication is known
研究组 & 干预措施
Placebo
Each participant in the placebo group will take matching placebo.
干预措施: Placebo (Drug)
Xuesaitong Soft Capsule
Each participant in the Xuesaitong Soft Capsule treatment group will take a daily dose of 1.32g.
干预措施: Xuesaitong Soft Capsule (Drug)
结局指标
主要结局
hsCRP
时间窗: 12 weeks
Changes in high-sensitivity C-reactive protein level from baseline at 12 weeks
次要结局
- Other inflammation indicators(12 weeks)
- Vascular endothelial function(12 weeks)
- Seattle Angina Questionnaire(12 weeks)
- Blood lipid profiles(12 weeks)
- IPA(12 weeks)
- SF-36(12 weeks)
研究者
Jing Li
JingLi, MD, PhD, professor
China National Center for Cardiovascular Diseases