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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
88
Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
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)
Time frame: 2 weeks±4 days
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)
Time frame: 2 weeks±4 days
Frequency of indigestion occurrence
Time frame: 2 weeks ±4 days, 12 weeks±7 days
Rate of bleeding events (BARC criteria)
Time frame: 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
Time frame: 2 weeks ±4 days, 12 weeks±7 days
AA-induced platelet inhibition rate (TEG method)
Time frame: 2 weeks ±4 days
ADP-induced platelet inhibition rate (TEG method)
Time frame: 2 weeks ±4 days
DeMeester score
Min 0, no upper limit, and higher scores mean a worse outcome
Time frame: 2 weeks ±4 days
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