Effect of Indobufen Versus Aspirin on Gastric Acid Secretion and Gastroesophageal Reflux in Patients With Coronary Heart Disease and Gastroesophageal Reflux Disease Undergoing Dual Antiplatelet Therapy: a Prospective, Randomized, Double-blind, Double-dummy, Positive Drug Parallel Control Clinical Trials
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring
研究概览
简要总结
The dual antiplatelet therapy based on aspirin plays an important role in the treatment of patients with coronary heart disease. Although aspirin is widely used and effective, it has many limitations in the long-term including increased risk of bleeding. In patients with coronary heart disease and gastroesophageal reflux disease, the symptoms of gastroesophageal reflux are usually aggravated after the application of aspirin. As an antiplatelet drug, indobufen can reversibly and selectively inhibit platelet cyclooxygenase-1 (COX-1), thereby blocking the synthesis of thromboxane B2 (TXB2) and exerting its antiplatelet effect, and it does not affect the production of prostaglandins and endothelial prostacyclins in gastrointestinal mucosa. It has less gastrointestinal injury and lower risk of bleeding. This project is to study the effects of indobufen or aspirin on gastric acid secretion and gastroesophageal reflux in patients with coronary heart disease and gastroesophageal reflux disease treated with dual antiplatelet therapy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age 18-75 years
- •Patients with stable and unstable angina pectoris receiving dual antiplatelet therapy (combined with clopidogrel)
- •Coronary angiography indicating ≥50% stenosis in >2.0 mm vessels
- •Gastroesophageal Reflux Disease Diagnostic Questionnaire Score (≥8)
- •Signed informed consent
排除标准
- •Acute myocardial infarction within 1 month before admission
- •Patients undergoing treatment related to gastroesophageal reflux disease (e.g. proton pump inhibitors, etc.)
- •Patients receiving other antiplatelet drugs (such as cilostazol) and oral anticoagulants
- •Patients with cardiogenic shock (systolic blood pressure <90 mmHg and/or diastolic blood pressure <60 mmHg), severe heart failure (killip grade ≥3), hepatic insufficiency (AST/ALT more than twice the upper limit of normal value caused by non-cardiac diseases), prior stroke and renal dysfunction (GFR <60 ml/min)
- •Those with active hemorrhage, hemorrhagic diseases or tendency to bleeding, especially those with a history of cerebral hemorrhage
- •People who are known to be intolerant or allergic to aspirin, indobufen or clopidogrel
- •Patients with malignant tumors or with life expectancy <2 years
- •Pregnant women, lactating women, women of childbearing age who do not take effective contraceptive measures, or those who plan to conceive during the trial, or those who have positive results of HCG examination before the trial
- •Those who have participated in other clinical trials or are currently participating in other clinical trials within one month before the trial
- •According to the judgement of the researchers, patients could not complete the study or comply with the requirements of the study (e.g. memory or behavioral disorders, mental disorders, alcohol dependence, prior defaults)
研究组 & 干预措施
Indobufen
干预措施: Indobufen and aspirin mimetic (Drug)
Aspirin
干预措施: Aspirin and indobufen mimetic (Drug)
结局指标
主要结局
Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring
时间窗: 2 weeks±4 days
This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands)
次要结局
- Median value of intragastric pH during 24-hour intragastric pH monitoring(2 weeks±4 days)
- Frequency of indigestion occurrence(2 weeks ±4 days, 12 weeks±7 days)
- Rate of bleeding events (BARC criteria)(2 weeks ±4 days, 12 weeks±7 days)
- Gastroesophageal reflux disease questionnaire score (GerdQ score)(2 weeks ±4 days, 12 weeks±7 days)
- AA-induced platelet inhibition rate (TEG method)(2 weeks ±4 days)
- ADP-induced platelet inhibition rate (TEG method)(2 weeks ±4 days)
- DeMeester score(2 weeks ±4 days)
研究者
Shao-Ping Nie
Professor of Medicine, Director, Emergency & Critical Care Center
Beijing Anzhen Hospital