the Efficacy and Safety of Indobufen and Low-dose Aspirin in Different Regimens of Antiplatelet Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- platelet aggregation
研究概览
简要总结
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. The baseline values of platelet aggregation rate, plasmaThromboxaneB2 and urinary 11-dh ThromboxaneB2 are measured by Light Transmittance Aggregometry method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1 year. The stomach Intestinal reactions, small bleeding events are recorded.
详细描述
A total of 210 coronary atherosclerosis patients without indications for stent implantation are included. Exclusion criteria：Aspirin resistance, uncontrolled hypertension (> 160 / 100mmHg),hemoglobin concentration <100g /L, hemorrhagic disease or a history of bleeding tendency, taking other nonsteroidal drugs, severe liver disease history, malignant tumor, active gastric mucosa bleeding, percutaneous coronary intervention history, coronary artery bypass surgery, cardiac function grade Ⅳ.The baseline values of platelet aggregation rate, plasma TXB2 and urinary 11-dh TXB2 are measured by LTA method and ELISA after aspirin 100 mg /d ≥5d. Then the patients are randomly divided into 7 groups: Group1: aspirin 100 mg/d; Group2: aspirin 100 mg /2d; Groups3: aspirin 100 mg / 3d; Groups4: morning 50mg evening 50mg; Group5: aspirin 75mg / d; Group6: aspirin 50mg / d; Group7: indobufen100mg bid. One month later,arachidonic acid-induced platelet aggregation rate , plasma TXB2 and urine 11-dh TXB2 are analyzed again. All patients are followed-up for 1month,6months and1 year. The stomach Intestinal reactions, small bleeding events ,whether to take proton pump inhibitors are recorded.
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 (Participant)
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
- •Clinical diagnosis of coronary atherosclerosis without indications for stent implantation .
- •Patient aged >18 years and ≤75years. Must be able to swallow tablets
排除标准
- •Aspirin resistance; uncontrolled hypertension (> 160 / 100mmHg); hemoglobin <100g / L; hemorrhagic disease or bleeding tendency history; taking other non-steroidal drugs; severe liver disease history; malignant neoplasms; active gastric mucosa bleeding; PCI history; coronary artery bypass surgery; cardiac function grade Ⅳ.
研究组 & 干预措施
aspirin 100mg/d therapy
Group1: aspirin 100 mg/d;
干预措施: aspirin 100mg/d therapy (Drug)
aspirin 100mg/2d therapy
Group2: aspirin ;
干预措施: aspirin 100mg/2d therapy (Drug)
aspirin 100mg/3d therapy
Groups3: aspirin ;
干预措施: aspirin 100mg/3d therapy (Drug)
indobufen 100mg bid therapy
Group7: 100mg bid
干预措施: indobufen 100mg bid therapy (Drug)
aspirin 50mg bid therapy
Groups4: morning 50mg evening 50mg;
干预措施: aspirin 50mg bid therapy (Drug)
aspirin 75mg/d therapy
Group5: aspirin 75mg / d;
干预措施: aspirin 75mg/d therapy (Drug)
aspirin 50mg/d therapy
Group6: aspirin 50mg / d;
干预措施: aspirin 50mg/d therapy (Drug)
结局指标
主要结局
platelet aggregation
时间窗: 2 hours
Regional differences between blood samples from each subjects of different groups by LTA.The results of LTA are reported in platelet aggregation rate(%).Platelet aggregation was induced by0.5mg/ml arachidonic acid (AA).
plasma thromboxaneB2
时间窗: 3montshs
The plasma thromboxane B2 concentration of each subjects are measured by enzyme-linked immunosorbent assay .(cayman chemical, thromboxaneB2 express EIA kit-Monoclonal)
urine 11-dehydro thromboxaneB2
时间窗: 3 months
The urine 11-dehydro thromboxane B2 concentration of each subjects are measured by ELISA.(cayman chemical,11-dehydro thromboxaneB2 ELISA kit-Monoclonal)
次要结局
未报告次要终点
研究者
Chunjian Li
professor
The First Affiliated Hospital with Nanjing Medical University