Coronary Artery DiseasePhase 4SECURENCT04129008
GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy
A Phase 4 study testing Indobufen and aspirin mimetic and Aspirin and indobufen mimetic in people with Coronary Artery Disease and Gastroesophageal Reflux Disease, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease, Gastroesophageal Reflux Disease
- What is being tested?
- Indobufen and aspirin mimetic and Aspirin and indobufen mimetic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2019to 31 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@ccmu.edu.cn
Huangtai Miao, 86-10-84005255, miaohuangtai@163.com
About this study
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
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.
- Being tested
- Indobufen and aspirin mimetic, Aspirin and indobufen mimetic
- Keywords
- coronary heart disease, gastroesophageal reflux disease, indobufen, aspirin
- Medical subject headings
- Coronary Artery Disease, Gastroesophageal Reflux, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indobufen and aspirin mimeticDrug
Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
Aspirin and indobufen mimeticDrug
Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic
| Study group | Role | What they receive |
|---|---|---|
| Indobufen | Experimental | Not described Receives: Drug: Indobufen and aspirin mimetic |
| Aspirin | Active comparator | Not described Receives: Drug: Aspirin and indobufen mimetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks±4 days
Secondary outcomes (7)
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)
Measured: 2 weeks±4 days
Frequency of indigestion occurrence
Measured: 2 weeks ±4 days, 12 weeks±7 days
Rate of bleeding events (BARC criteria)
Measured: 2 weeks ±4 days, 12 weeks±7 days
Gastroesophageal reflux disease questionnaire score (GerdQ score)
Min 0, max 18, and higher scores mean a worse outcome
Measured: 2 weeks ±4 days, 12 weeks±7 days
AA-induced platelet inhibition rate (TEG method)
Measured: 2 weeks ±4 days
ADP-induced platelet inhibition rate (TEG method)
Measured: 2 weeks ±4 days
DeMeester score
Min 0, no upper limit, and higher scores mean a worse outcome
Measured: 2 weeks ±4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start17 Oct 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129008
- Sponsor's protocol ID
- 2019026
- Acronym
- SECURE
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04129008
- Acronym / sponsor ID
- SECURE / 2019026
- Keywords
- coronary heart disease, gastroesophageal reflux disease, indobufen, aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 17 Oct 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indobufen | Experimental | Drug: Indobufen and aspirin mimetic |
| Aspirin | Active comparator | Drug: Aspirin and indobufen mimetic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indobufen and aspirin mimeticDay 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg | Drug | Indobufen |
| Aspirin and indobufen mimeticDay 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic | Drug | Aspirin |
Primary outcome
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)
7 secondary outcomes
Median value of intragastric pH during 24-hour intragastric pH monitoring
Time frame: 2 weeks±4 days
Frequency of indigestion occurrence
Time frame: 2 weeks ±4 days, 12 weeks±7 days
Rate of bleeding events (BARC criteria)
Time frame: 2 weeks ±4 days, 12 weeks±7 days
Gastroesophageal reflux disease questionnaire score (GerdQ score)
Time frame: 2 weeks ±4 days, 12 weeks±7 days
AA-induced platelet inhibition rate (TEG method)
Time frame: 2 weeks ±4 days
ADP-induced platelet inhibition rate (TEG method)
Time frame: 2 weeks ±4 days
DeMeester score
Time frame: 2 weeks ±4 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indobufen and aspirin mimetic and Aspirin and indobufen mimetic in people with Coronary Artery Disease and Gastroesophageal Reflux Disease, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shao-Ping Nie, MD, PhD (86-10-84005256, spnie@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage time of intragastric pH<4.0 during 24-hour intragastric pH monitoring (time frame: 2 weeks±4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.