Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indobufen | Experimental |
| |
| Aspirin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indobufen and aspirin mimetic | Drug | Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring | This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands) | 2 weeks±4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Median value of intragastric pH during 24-hour intragastric pH monitoring | This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands) | 2 weeks±4 days |
| Frequency of indigestion occurrence |
| Measure | Description | Time Frame |
|---|---|---|
| AA-induced platelet inhibition rate (LTA method) | 2 weeks±4 days | |
| ADP-induced platelet inhibition rate (LTA method) | 2 weeks±4 days | |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shao-Ping Nie, MD, PhD | Contact | 86-10-84005256 | spnie@ccmu.edu.cn | |
| Xiao Wang, MD | Contact | 86-10-84005255 | spaceeye123@126.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | 100029 | China |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D005764 | Gastroesophageal Reflux |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C020371 | indobufen |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Aspirin and indobufen mimetic | Drug | Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic |
|
| 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) | Min 0, max 18, and higher scores mean a worse outcome | 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 | Min 0, no upper limit, and higher scores mean a worse outcome | 2 weeks ±4 days |
| 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 |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |