A Single-center, Prospective, Randomized, Double-blind, Controlled Trial for the Effect of Allopurinol Sustained-release Capsules on the Stability of Coronary Plaques in Patients With Acute Coronary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- low attenuation plaque volume
研究概览
简要总结
The pathogenesis of coronary heart disease is closely related to inflammation. IL-1 beta is an effective target for anti-inflammatory treatment of coronary heart disease. Allopurinol is a drug used for treating hyperuricemia and gout for many years. Recently, allopurinol has been proved to inhibit the production of NLRP3 in monocytes and reduce the level of IL-1beta, resulting in the decrease of TNF-alpha, IL-6 and CRP. Thus, in this study, the investigators aim to evaluate the efficacy and safety of allopurinol sustained-release capsules on improving the stability of coronary plaque in patients with acute coronary syndrome treated by conventional standardized therapy by the single-center, prospective, randomized, double-blind and controlled methods, which would provide new strategies for the treatment of coronary heart 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the people who understand and would sign the informed consent voluntarily;
- •Aged 18 to 80 years old;
- •hospitalized patients diagnosed as acute coronary syndrome in the past 1 months;
- •hsCRP > 2mg/L;
- •allopurinol allergy gene HLA-B5801 was negative.
排除标准
- •history of coronary artery bypass grafting;
- •allergy to allopurinol or any excipient;
- •administration of allopurinol or other uric-acid-lowering drugs within 7 days before randomization;
- •abnormal liver function (ALT >1.5 fold of the upper limit);
- •renal dysfunction (creatinine clearance rate <45 ml/min);
- •thrombocytopenia (PLT<100g/L);
- •gout patients;
- •uncontrolled infectious diseases in screening period;
- •Thyroid dysfunction, moderate to severe anemia (hemoglobin < 90g/L), systemic lupus erythematosus, malignant hematopathy, leukopenia, asthma, inflammatory bowel disease and other immune diseases were found during the screening period;
- •Non-steroidal anti-inflammatory drugs, steroid hormone, immunomodulatory and chemotherapeutic drugs not included in the study protocol should be taken for a long time during the study period;
- •the history of surgery or interventional operation within 6 months before the screening period;
- •patients with mental disorders such as anxiety or depression;
- •pregnant women, lactating women or women of childbearing age who did not use effective contraceptive measures ;
- •patients who participated in other clinical trials 3 months before the screening period;
- •the researchers judged that patients were not suitable for this clinical trials.
研究组 & 干预措施
Treatment group
干预措施: allopurinol sustained-release capsules (Drug)
Control group
干预措施: placebo capsules (Drug)
结局指标
主要结局
low attenuation plaque volume
时间窗: 12 months
Changes of low attenuation plaque volume measured by coronary CTA
次要结局
- total plaque volume(12 months)
- Readmission rate of acute coronary syndrome(12 months)
- restructure index(12 months)
- All-cause mortality(12 months)
- inflammatory factors hsCRP(12 months)
研究者
Xiang Cheng
Head of department of cardiology, Wuhan Union Hospital, China
Wuhan Union Hospital, China