Status:
UNKNOWN
GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Coronary Artery Disease
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04129008
Start Date
October 17 2019
End Date
December 31 2020
Last Update
October 16 2019
Active Locations (1)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029