Hydroxychloroquine Assessment of Management Study in Coronary Artery Disease After Angiography.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- change of fasting high sensitivity C-reactive protein
研究概览
简要总结
The purpose of this study is to evaluate whether treated with hydroxychloroquine could improve therapeutic effect for patients with high-risk coronary artery disease.
详细描述
This double blind, placebo, randomized controlled trial is going to assess if hydroxychloroquine could improve the high sensitivity C-reaction protein, blood lipid, blood glucose and blood pressure, also whether hydroxychloroquine could affect the secretion of inflammatory cytokines and the M1/M2 phenotype polarization of macrophages in patients with high-risk coronary artery disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have been diagnosed coronary artery disease by coronary angiography or CT angiography.
- •coronary artery disease with hypertension or diabetes or hyperlipidaemia(LDL>1.8mmol/L)
- •High sensitivity C-reactive protein >1mg/L.
- •On guideline-based secondary prevention of coronary heart disease medications≥1 months.
- •No use of steroids, antibiotics, immunosuppressors a week before treatment.
排除标准
- •Retinal disease.
- •Chronic hepatopathy(ALT>120U/L).
- •Renal dysfunction (eGFR<60).
- •Moderately severe anemia, thrombocytopenia and leukocytopenia.
- •Other contraindications for hydroxychloroquine.
- •Active hemorrhage.
- •Cancer or life expectancy< a year.
- •New York Heart Association (NYHA) functional class≥class III, Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in plan.
- •Pregnancy and lactation.
研究组 & 干预措施
Hydroxychloroquine
Subjects are treated with hydroxychloroquine sulfate tablets.All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
干预措施: Hydroxychloroquine Sulfate Tablets (Drug)
placebo
Subjects are treated with placebo tablets. All the subjects are treated with guideline-based secondary prevention of coronary heart disease medications.
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
change of fasting high sensitivity C-reactive protein
时间窗: change from baseline at the 16th week, 39th week, 55th week.
次要结局
- change of blood pressure(change from baseline at the 12th week, 20th week.)
- change of fasting blood lipid(change from baseline at the 12th week, 20th week.)
- change of fasting insulin(change from baseline at the 12th week, 20th week.)
- change of echocardiogram(change from baseline at the 12th week, 20th week.)
- change of fasting Interleukin 6(change from baseline at the 12th week, 20th week.)
- change of fasting tumor necrosis factor(change from baseline at the 12th week, 20th week.)
- change of fasting blood glucose(change from baseline at the 12th week, 20th week.)