GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy

Coronary Artery Disease Clinical Trial

— SECURE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04129008
• Other study ID #: 2019026
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 17, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2019
• Source: Beijing Anzhen Hospital
• Contact: Shao-Ping Nie, MD, PhD
• Phone: 86-10-84005256
• Email: spnie[@]ccmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Indobufen and aspirin mimetic
Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
• Aspirin and indobufen mimetic
Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AA-induced platelet inhibition rate (LTA method)		2 weeks±4 days
Other	ADP-induced platelet inhibition rate (LTA method)		2 weeks±4 days
Other	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
Other	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
Primary	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
Secondary	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
Secondary	Frequency of indigestion occurrence		2 weeks ±4 days, 12 weeks±7 days
Secondary	Rate of bleeding events (BARC criteria)		2 weeks ±4 days, 12 weeks±7 days
Secondary	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
Secondary	AA-induced platelet inhibition rate (TEG method)		2 weeks ±4 days
Secondary	ADP-induced platelet inhibition rate (TEG method)		2 weeks ±4 days
Secondary	DeMeester score	Min 0, no upper limit, and higher scores mean a worse outcome	2 weeks ±4 days