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

Primary Purpose

Coronary Artery Disease, Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Indobufen and aspirin mimetic
Aspirin and indobufen mimetic
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary heart disease, gastroesophageal reflux disease, indobufen, aspirin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Beijing Anzhen Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Indobufen

Aspirin

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Frequency of indigestion occurrence
Rate of bleeding events (BARC criteria)
Gastroesophageal reflux disease questionnaire score (GerdQ score)
Min 0, max 18, and higher scores mean a worse outcome
AA-induced platelet inhibition rate (TEG method)
ADP-induced platelet inhibition rate (TEG method)
DeMeester score
Min 0, no upper limit, and higher scores mean a worse outcome

Full Information

First Posted
October 8, 2019
Last Updated
October 14, 2019
Sponsor
Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04129008
Brief Title
GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 17, 2019 (Anticipated)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Gastroesophageal Reflux Disease
Keywords
coronary heart disease, gastroesophageal reflux disease, indobufen, aspirin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indobufen
Arm Type
Experimental
Arm Title
Aspirin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Indobufen and aspirin mimetic
Intervention Description
Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
Intervention Type
Drug
Intervention Name(s)
Aspirin and indobufen mimetic
Intervention Description
Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic
Primary Outcome Measure Information:
Title
Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring
Description
This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands)
Time Frame
2 weeks±4 days
Secondary Outcome Measure Information:
Title
Median value of intragastric pH during 24-hour intragastric pH monitoring
Description
This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands)
Time Frame
2 weeks±4 days
Title
Frequency of indigestion occurrence
Time Frame
2 weeks ±4 days, 12 weeks±7 days
Title
Rate of bleeding events (BARC criteria)
Time Frame
2 weeks ±4 days, 12 weeks±7 days
Title
Gastroesophageal reflux disease questionnaire score (GerdQ score)
Description
Min 0, max 18, and higher scores mean a worse outcome
Time Frame
2 weeks ±4 days, 12 weeks±7 days
Title
AA-induced platelet inhibition rate (TEG method)
Time Frame
2 weeks ±4 days
Title
ADP-induced platelet inhibition rate (TEG method)
Time Frame
2 weeks ±4 days
Title
DeMeester score
Description
Min 0, no upper limit, and higher scores mean a worse outcome
Time Frame
2 weeks ±4 days
Other Pre-specified Outcome Measures:
Title
AA-induced platelet inhibition rate (LTA method)
Time Frame
2 weeks±4 days
Title
ADP-induced platelet inhibition rate (LTA method)
Time Frame
2 weeks±4 days
Title
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)
Time Frame
2 weeks±4 days, 12 weeks±7days
Title
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
Time Frame
2 weeks±4 days, 12 weeks±7days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shao-Ping Nie, MD, PhD
Phone
86-10-84005256
Email
spnie@ccmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao Wang, MD
Phone
86-10-84005255
Email
spaceeye123@126.com
Facility Information:
Facility Name
Beijing Anzhen Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao-Ping Nie, MD, PhD
Phone
86-10-84005256
Email
spnie@ccmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Huangtai Miao
Phone
86-10-84005255
Email
miaohuangtai@163.com

12. IPD Sharing Statement

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

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