Coronary Artery Disease, Gastroesophageal Reflux Disease
Conditions
Keywords
coronary heart disease, gastroesophageal reflux disease, indobufen, aspirin
Brief summary
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.
Interventions
DRUGIndobufen and aspirin mimetic
Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
DRUGAspirin and indobufen mimetic
Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic
Sponsors
Beijing Anzhen Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring | 2 weeks±4 days | This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Min 0, max 18, and higher scores mean a worse outcome |
| 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 | Min 0, no upper limit, and higher scores mean a worse outcome |
| Median value of intragastric pH during 24-hour intragastric pH monitoring | 2 weeks±4 days | This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands) |
| Frequency of indigestion occurrence | 2 weeks ±4 days, 12 weeks±7 days | — |
Other
| Measure | Time frame |
|---|---|
| Rate of major adverse cardiovascular event (MACE, including all-cause death, non-fatal myocardial infarction, ischemic stroke, ischemia-driven revascularization, or rehospitalization for heart failure) | 2 weeks±4 days, 12 weeks±7days |
| Rate of single endpoint of cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, ischemic stroke, ischemic-driven revascularization, rehospitalization for heart failure, and all-cause death | 2 weeks±4 days, 12 weeks±7days |
| AA-induced platelet inhibition rate (LTA method) | 2 weeks±4 days |
| ADP-induced platelet inhibition rate (LTA method) | 2 weeks±4 days |
Countries
China
Contacts
Primary ContactShao-Ping Nie, MD, PhD
Backup ContactXiao Wang, MD
Outcome results
None listed