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

Sponsor

Beijing Anzhen Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04129008

Collaborator

(none)

Enrollment

Location

Arms

14.5

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Gastroesophageal Reflux Disease	Drug: Indobufen and aspirin mimetic Drug: Aspirin and indobufen mimetic	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Oct 17, 2019

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Indobufen	Drug: Indobufen and aspirin mimetic Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
Active Comparator: Aspirin	Drug: Aspirin and indobufen mimetic Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic

Arm

Intervention/Treatment

Experimental: Indobufen

Drug: Indobufen and aspirin mimetic

Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg

Active Comparator: Aspirin

Drug: Aspirin and indobufen mimetic

Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic

Outcome Measures

Primary Outcome Measures

Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring [2 weeks±4 days]
This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands)

Secondary Outcome Measures

Median value of intragastric pH during 24-hour intragastric pH monitoring [2 weeks±4 days]
This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands)
Frequency of indigestion occurrence [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) [2 weeks ±4 days, 12 weeks±7 days]
Min 0, max 18, and higher scores mean a worse outcome
AA-induced platelet inhibition rate (TEG method) [2 weeks ±4 days]
ADP-induced platelet inhibition rate (TEG method) [2 weeks ±4 days]
DeMeester score [2 weeks ±4 days]
Min 0, no upper limit, and higher scores mean a worse outcome

Other Outcome Measures

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) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)