Clinical trial NCT04129008: GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Gastroesophageal Reflux Disease
Keywords: coronary heart disease
gastroesophageal reflux disease
indobufen
aspirin
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring
timeFrame: 2 weeks±4 days
Secondary outcomes:
measure: Median value of intragastric pH during 24-hour intragastric pH monitoring
timeFrame: 2 weeks±4 days
measure: Frequency of indigestion occurrence
timeFrame: 2 weeks ±4 days, 12 weeks±7 days
measure: Rate of bleeding events (BARC criteria)
timeFrame: 2 weeks ±4 days, 12 weeks±7 days
measure: Gastroesophageal reflux disease questionnaire score (GerdQ score)
timeFrame: 2 weeks ±4 days, 12 weeks±7 days
measure: AA-induced platelet inhibition rate (TEG method)
timeFrame: 2 weeks ±4 days
measure: ADP-induced platelet inhibition rate (TEG method)
timeFrame: 2 weeks ±4 days
measure: DeMeester score
timeFrame: 2 weeks ±4 days
Other outcomes:
measure: AA-induced platelet inhibition rate (LTA method)
timeFrame: 2 weeks±4 days
measure: ADP-induced platelet inhibition rate (LTA method)
timeFrame: 2 weeks±4 days
measure: 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)
timeFrame: 2 weeks±4 days, 12 weeks±7days
measure: 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
timeFrame: 2 weeks±4 days, 12 weeks±7days
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: