Effect of Indobufen and Aspirin on Platelet Aggregation and Long Term Prognosis in Patients With Stable Coronary Heart Disease. A Prospective, Randomized and Controlled，Single Blind, Single-center, Opening Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 594
- 主要终点
- Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
研究概览
简要总结
This study evaluates the effect of Indobufen and Aspirin on platelet aggregation and long term prognosis in patients with stable 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
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The treatment in this study was open. Optical density turbidimetric platelet aggregation (LTA) and thromboelastography (TEG) were used to detect the platelet aggregation rate induced by AA and ADP, and the metabolites were measured by ELISA. All were done by the laboratory personnel, and they were unaware of the setting of treatment medication (blind method).
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years < age ≤ 85 years;
- •Patients with confirmed stable coronary heart disease (must meet at least one of the following conditions);
- •2.1 a stenosis confirmed by Coronary angiography or dual-source CT, but the stenosis of the Left Main Artery (LMA) diameter is less than 50%, the stenosis of the left anterior descending branch（LAD）is less than 70%, and the stenosis of the two or three coronary arteries diameter is less than 70%, patient has no corresponding evidence of ischemia;
- •2.2 Patients after percutaneous coronary intervention (PCI): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
- •2.3 Patients after coronary artery bypass graft (CABG): Dual antiplatelet therapy (DAPT) time is greater than 9 months, without cardiovascular events and ischemic symptoms; and currently receiving aspirin 100 mg/d with clopidogrel 75 mg/d or ticagrelor 90mg (bid) dual antiplatelet therapy.
- •Willing to sign the informed consent.
排除标准
- •Acute coronary syndrome (ACS) occurred within 3 months before screening;
- •Percutaneous coronary intervention or CABG surgery within 9 months before screening;
- •Any other conditions (such as atrial fibrillation, pulmonary embolism, lower extremity venous thrombosis, artificial heart valve, etc.) who need oral or intravenous anticoagulation treatment;
- •In the past 3 months, the Arachidonic acid-induced platelet aggregation rate≥ 50%; inhibition rate ≤ 20% in the aspirin combined with clopidogrel treated patients;
- •Congestive heart failure or left ventricular ejection fraction <35%;
- •A positive history of Chronic Obstructive Pulmonary Disease (COPD);
- •bleeding tendency or severe lung disease;
- •Active pathological bleeding;
- •History of intracranial hemorrhage (less than 3 months);
- •Allergic to indobufen / aspirin (or any of its ingredients);
- •Severe liver injury (transaminases exceeding the upper limit of 2 times and above);
- •Pregnancy, lactation and those who have a birth plan;
- •Hematological diseases, platelet count <100000 / mm3 or hemoglobin <10g / dL;
- •Have a history of drug or alcohol abuse in the past 2 years;
- •Use of non-steroidal anti-inflammatory drugs (within 3 months);
- •Creatinine clearance <30ml/min;
研究组 & 干预措施
Indobufen
200 mg Indobufen, bid po, 90 days
干预措施: Indobufen (Drug)
Aspirin
100 mg Aspirin, qd po, 90 days
干预措施: Aspirin (Drug)
结局指标
主要结局
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 30 days after taking the Indobufen or Aspirin
时间窗: 30 days
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 30 days.
Concentration of Thromboxane B2 (TXB2) at baseline
时间窗: baseline
The fasting blood was collected after the subjects signed informed consent；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 90 days after taking the Indobufen or Aspirin
时间窗: 90 days
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 90 days.
Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates 7 days after taking the Indobufen or Aspirin
时间窗: 7 days
Patients with stable coronary heart disease were treated with Indobufen or Aspirin for 90 days. Subsequently, the investigators used the Light transmission aggregation(LTA) and Thrombelastography (TEG) methods to detect the Arachidonic acid and Adenosine diphosphate-induced platelet aggregation rates on the 7 days.
Concentration of Thromboxane B2 (TXB2) 30 days after taking the Indobufen or Aspirin
时间窗: 30 days
The fasting blood was collected 30 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 90 days after taking the Indobufen or Aspirin
时间窗: 90 days
The fasting blood was collected 90 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
Concentration of Thromboxane B2 (TXB2) 7 days after taking the Indobufen or Aspirin
时间窗: 7 days
The fasting blood was collected 7 days after taking the Indobufen or Aspirin；And the concentration of TXB2 was detected by enzyme-linked immuno sorbent assay (ELISA)
次要结局
- Incidence of Bleeding(baseline, 7, 30 and 90 days)
- Blood concentration(7, 30 and 90 days)
- Incidence of Adverse Gastrointestinal reaction(7, 30 and 90 days)
- Major adverse cardiovascular events(7, 30 and 90 days)
- Cyclooxygenase-1 gene phenotype(baseline)