Suspended

SECUREEffect 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

What is being tested

Indobufen and aspirin mimetic

+ Aspirin and indobufen mimetic

Drug

Who is being recruted

Arterial Occlusive Diseases+11

+ Arteriosclerosis

+ Cardiovascular Diseases

From 18 to 75 Years

+15 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: October 2019

See protocol details

Summary

Principal SponsorBeijing Anzhen Hospital

Study ContactShao-Ping Nie, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: October 17, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleEffect 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

NCT04129008

Principal SponsorBeijing Anzhen Hospital

Study ContactShao-Ping Nie, MD, PhDMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseDeglutition DisordersDigestive System DiseasesEsophageal DiseasesGastroesophageal RefluxGastrointestinal DiseasesHeart DiseasesVascular DiseasesEsophageal Motility DisordersMyocardial Ischemia

Criteria

5 inclusion criteria required to participate

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)

Show More Criteria

10 exclusion criteria prevent from participating

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Beijing Anzhen Hospital, Capital Medical University

Beijing, ChinaOpen Beijing Anzhen Hospital, Capital Medical University in Google Maps

SuspendedOne Study Center