A Comparative Study on Antiplatelet Efficacy of Indobufen and Aspirin in Patients With Coronary Atherosclerosis
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TXB2
研究概览
简要总结
In addition, studies have found that indobufen can inhibit coagulation function in rats. Compared with aspirin, the duration of antiplatelet efficacy of indobufen was shorter, and the platelet function recovered completely 24 hours after drug withdrawal. However, there are few studies on the antiplatelet efficacy of indobufen. The investigators' previous study found that the inhibitory effect of indobufen 100 mg Bid on COX system in atherosclerosis or healthy volunteers was equivalent to that of aspirin 100 mg QD, but the inhibitory effect on platelet COX-1 channel was significantly weaker than that of aspirin 100 mg QD. In view of this, this study intends to investigate the antiplatelet effect of indobufen 200 mg Bid in patients with coronary atherosclerosis by comparing it with conventional-dose aspirin 100 mg QD.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of coronary atherosclerosis without indications for stent implantation.
- •Age ≥ 18 years, ≤ 65 years
- •Sign informed consent
排除标准
- •A history of asthma or allergic constitution or known allergy to indobufen or aspirin.
- •High risk of bleeding (low hemoglobin 10g / L, history of peptic ulcer disease, fecal occult blood positive or known active bleeding, history of cerebral hemorrhage within 6 months, history of fundus hemorrhage, etc).
- •Creatinine was 1.2 times higher than the upper limit of normal value and ALT was 1.2 times higher than the normal value.
- •History of smoking and alcoholism.
- •History of diabetes.
- •Pregnancy and lactation women.
- •Nonsteroidal anti-inflammatory or other antithrombotic drugs other than indobufen are required.
- •Any other reason may affect the results of this study.
研究组 & 干预措施
aspirin 100 mg/d therapy
干预措施: aspirin 100 mg/d (Drug)
indobufen 200 mg bid therapy
干预措施: indobufen 200 mg bid (Drug)
结局指标
主要结局
TXB2
时间窗: Within 1 month after one month of medication
Plasma thromboxaneB2
11-dh-TXB2
时间窗: Within 1 month after one month of medication
Urine 11-dehydro thromboxaneB2
MPA
时间窗: Within 24 hours after one month of medication
Maximum platelet aggregation induced by arachidonic acid
次要结局
- Adverse Events(Within 1 month after the first medication)
研究者
Chunjian Li
Dr., MD, Ph.D, Director of CCU Ward
The First Affiliated Hospital with Nanjing Medical University