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

NCT04129008 | Unknown Phase 4

• 1 other identifier: 2019026
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Gastroesophageal Reflux Disease

Keywords

coronary heart disease; gastroesophageal reflux disease; indobufen; aspirin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Median value of intragastric pH during 24-hour intragastric pH monitoring

  2 weeks±4 days

• 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

• AA-induced platelet inhibition rate (TEG method)

  2 weeks ±4 days

Other Outcomes (4)

• 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

Study Arms (2)

Indobufen

EXPERIMENTAL

Drug: Indobufen and aspirin mimetic

Aspirin

ACTIVE COMPARATOR

Drug: Aspirin and indobufen mimetic

Interventions

Indobufen and aspirin mimetic DRUG

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

Indobufen

Aspirin and indobufen mimetic DRUG

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

Aspirin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, 100029, China

Location

MeSH Terms

Conditions

Coronary Artery Disease; Gastroesophageal Reflux; Coronary Disease

Interventions

indobufen; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Shao-Ping Nie, MD, PhD

CONTACT

86-10-84005256; spnie@ccmu.edu.cn

Xiao Wang, MD

CONTACT

86-10-84005255; spaceeye123@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director, Emergency & Critical Care Center

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 16, 2019
• Study Start: October 17, 2019
• Primary Completion: September 30, 2020
• Study Completion: December 31, 2020
• Last Updated: October 16, 2019

Record last verified: 2019-10

Locations

CN (1)