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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04129008
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
Shao-Ping Nie, Beijing Anzhen Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 17, 2019
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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




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


Secondary Outcome Measures :
  1. Median value of intragastric pH during 24-hour intragastric pH monitoring [ Time Frame: 2 weeks±4 days ]
    This parameter will be detected by 24-hour intragastric pH monitoring (Medical Measurement Systems, Netherlands)

  2. Frequency of indigestion occurrence [ Time Frame: 2 weeks ±4 days, 12 weeks±7 days ]
  3. Rate of bleeding events (BARC criteria) [ Time Frame: 2 weeks ±4 days, 12 weeks±7 days ]
  4. Gastroesophageal reflux disease questionnaire score (GerdQ score) [ Time Frame: 2 weeks ±4 days, 12 weeks±7 days ]
    Min 0, max 18, and higher scores mean a worse outcome

  5. AA-induced platelet inhibition rate (TEG method) [ Time Frame: 2 weeks ±4 days ]
  6. ADP-induced platelet inhibition rate (TEG method) [ Time Frame: 2 weeks ±4 days ]
  7. DeMeester score [ Time Frame: 2 weeks ±4 days ]
    Min 0, no upper limit, and higher scores mean a worse outcome


Other Outcome Measures:
  1. AA-induced platelet inhibition rate (LTA method) [ Time Frame: 2 weeks±4 days ]
  2. ADP-induced platelet inhibition rate (LTA method) [ Time Frame: 2 weeks±4 days ]
  3. 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 ]
  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04129008


Contacts
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Contact: Shao-Ping Nie, MD, PhD 86-10-84005256 spnie@ccmu.edu.cn
Contact: Xiao Wang, MD 86-10-84005255 spaceeye123@126.com

Locations
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China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029
Contact: Shao-Ping Nie, MD, PhD    86-10-84005256    spnie@ccmu.edu.cn   
Contact: Huangtai Miao    86-10-84005255    miaohuangtai@163.com   
Sponsors and Collaborators
Beijing Anzhen Hospital

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Responsible Party: Shao-Ping Nie, Professor of Medicine, Director, Emergency & Critical Care Center, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT04129008    
Other Study ID Numbers: 2019026
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: October 16, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shao-Ping Nie, Beijing Anzhen Hospital:
coronary heart disease
gastroesophageal reflux disease
indobufen
aspirin
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophagitis, Peptic
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esophagitis
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Aspirin
Indobufen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents