Gastrointestinal Ulcer (Peptic) or ErosionPhase 4DACAB-GI-2NCT03908593
Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG
A Phase 4 study testing Pantoprazole in people with Gastrointestinal Ulcer (Peptic) or Erosion and Anti-Platelet Therapy, run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the efficacy and safety for 12- vs. 1-month of pantoprazole treatment in preventing dual antiplatelet therapy (DAPT)-related upper gastrointestinal mucosal injury after coronary artery bypass grafting (CABG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Ulcer (Peptic) or Erosion, Anti-Platelet Therapy, Coronary Artery Bypass
- What is being tested?
- Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2019to 30 Jan 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each patient should meet all of the inclusion criteria and none of the exclusion criteria for this study:
- Provision of signed informed consent prior to any study specific procedures.
- Male or female, age ≥ 18 years at the time of consent.
- Planned or initiated use of 12 months of DAPT (aspirin plus clopidogrel or aspirin plus ticagrelor) immediately following primary isolated elective CABG surgery.
Who cannot join
- Patients should not enter the study if any of the following exclusion criteria are fulfilled.
- History of previous active peptic ulcer within 3 months prior to enrollment.
- Planned use of PPIs to treat acid-associated disorders (e.g. gastroesophageal reflux disease, GERD)
- Contraindications for aspirin, clopidogrel, ticagrelor and pantoprazole use (e.g. known allergy)
- Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices, that cannot be stopped for the course of the study.
- Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir
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- CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses > 40mg daily or lovastatin at doses > 40mg daily.
- Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin.
- Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgement of investigator OR women who have a positive pregnancy test at enrollment or randomization OR women who are breasting-feeding.
- Inability of patient to understand and/or comply with study procedures and/or follow up, in the opinion of the investigator, OR any conditions that, in the opinion of the investigator, many render the patient unable to complete the study.
- Any condition outside the atherothrombotic study area with a life expectancy of less than 1 year.
- Participation in another clinical study with an investigational product within 28 days prior to enrolment or previous randomization to an investigational product in another ongoing clinical study.
- Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, long-term concomitant treatment with non-steroidal anti-inflammatory drugs [NSAIDs])
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
About this study
Official title: Evaluation of the Efficacy of Different Duration of a Proton Pump Inhibitor in the Prevention of Upper Gastrointestinal Mucosal Injury in Patients Taking 12-month Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting
The purpose of this study is to compare the efficacy and safety for 12- vs. 1-month of pantoprazole treatment in preventing dual antiplatelet therapy (DAPT)-related upper gastrointestinal mucosal injury after coronary artery bypass grafting (CABG).
To date, there has been no study using esophagogastroduodenoscopy (EGD) to compare the differences in upper gastrointestinal mucosal injury (including reflux esophagitis) after 6 and 12 months of PPI treatment combined with two different DAPT regimens (clopidogrel plus aspirin or ticagrelor plus aspirin).
Read the detailed description
This prospective trial was designed as a single-center, open-label, randomized controlled trial with patients allocated in a ratio of 1:1. Within 3 days after CABG, patients willing to participate in the study will be carefully evaluated by a cardiac surgeon together with a gastroenterologist based on inclusion and exclusion criteria. Patients will be followed up to 12 months post-randomization unless death. The outcome will be collected at 2±1 days, 9±2 days, 1 month, 3 months (phone call), 6 months, 9 months (phone call), and 12 months after CABG surgery, respectively. 13C urea breath testing is used to detect Helicobacter pylori (H. pylori) infection before enrollment. At 6 and 12 months post-randomization, routine laboratory tests and EGD will be performed respectively. Computed tomographic angiography (CTA) or coronary angiography (CAG) is also required at 12 months post-randomization.
Definition of end of the study
- The date on which the last subject completed the last follow-up was the endpoint of this study.
- During the follow-up period, if the patient's biopsy pathological report showed that EGD detects precancerous lesions (e.g., atypical hyperplasia, low-grade or high-grade internal neoplasia, etc.) or malignant lesions.
- Patients randomized to the control group (1-month pantoprazole treatment group) should continue PPI treatment if GERD-Q questionnaire score 8, endoscopic findings of reflux esophagitis (LA-A and above), gastroduodenal mucosal injury of modified Lanza score of 4, or upper gastrointestinal bleeding at any time during the follow-up period.
Following the ITT principle, all patients randomized in this study should be evaluated for primary and secondary endpoints regardless of changes in PPI treatment. Thus, patients in the 1-month pantoprazole treatment group required PPI treatment at any time after 1 month and could also be assessed for primary and secondary endpoints.
According to the results of the preliminary study, the cumulative incidence rate of severe gastric and duodenal bulb erosion and ulcers of the 1-month PPI treatment group is assumed to be 36%, and that of the 12-month PPI treatment group was assumed to be 18%. Based on a two-sided α of 0.05 and a randomization ratio of 1:1, a total of 186 subjects are required to provide a power of 80%. Considering a 20% drop-out rate, the sample size of 232 subjects was determined.
In this study, all subjects received pantoprazole treatment for at least 1 month after CABG. Due to the COVID-19 pandemic, some subjects are unable to return to the center for study drugs and/or follow-up 1 month after the randomization. Those subjects who are unable to receive subsequent randomization intervention, will be excluded from the modified full analysis set and not included in the effectiveness analysis. Considering the statistical power of the study, randomized subjects will be added until the effective randomized intervention number reaches the predetermined sample size.
Two subgroup analyses will be performed in this study, including (1) H. pylori infection: negative and positive; (2) DAPT: aspirin + clopidogrel and aspirin + ticagrelor.
- Being tested
- Pantoprazole
- Keywords
- Gastrointestinal, Mucosal injury, Antiplatelet, Coronary artery bypass grafting, Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Also called PANTOLOC, Tablet from Takeda Pharmaceutical Company Limited
Pantoprazole (40mg qd) will be concomitant used with DAPT
| Study group | Role | What they receive |
|---|---|---|
| One month of therapy | Active comparator | Pantoprazole, 40mg, tablet, oral, once daily for 1 month Receives: Drug: Pantoprazole |
| Twelve months of therapy | Experimental | Pantoprazole, 40mg, tablet, oral, once daily for 12 months Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD.
Gastroduodenal erosions and ulcers will be assessed according to the Lanza Endoscopic Scoring System. Lanza score is a categorical score (0-4) and defined as follows: 0, normal; 1, mucosal hemorrhages only; 2, 1-2 erosions; 3, 3-10 erosions; 4, >10 erosions or an ulcer ≥3 mm. In addition, ≥1 ulcer with a diameter no less than 5mm will be grouped separately.
Measured: within 12 months after randomization
Secondary outcomes (4)
Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD.
Gastroduodenal erosions and ulcers will be assessed according to the Lanza Endoscopic Scoring System (0-4). In addition, ≥1 ulcer with a diameter ≥5mm will be grouped separately.
Measured: 6 months after randomization
Cumulative rate of patients with upper gastrointestinal bleeding (UGIB) according to the modified TIMI criteria.
According to the definition of non-CABG related bleeding in the modified TIMI criteria, the severity of UGIB is classified into 3 grades: major, minor and minimal. 1, Major: Clinically overt signs of hemorrhage associated with a drop in hemoglobin of ≥5 g/dL. 2, Minor: Clinically overt signs of UGIB, resulting in hemoglobin drop of 3 to <5 g/dL. 3, Minimal: Any overt bleeding event that does not meet the criteria above. According to the consensus updated by the Asia-Pacific working group in 2018, patients with hemodynamic shock and signs of UGIB should be offered urgent endoscopy after resuscitation and stabilization (Gut 2018; 67:1757-68).
Measured: within 12 months after randomization
Percentage of patients with reflux esophagitis evaluated by EGD.
According to the Los Angeles classification, endoscopic reflux esophagitis was assigned a grade from A to D.
Measured: 12 months after randomization
Percentage of patients with reflux esophagitis evaluated by EGD.
According to the Los Angeles classification, endoscopic reflux esophagitis was assigned a grade from A to D.
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start14 Oct 2019
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Ulcer (Peptic) or ErosionStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lifen YU, Ruijin Hospital
- Investigators
- Lifen Yu, MD, Ph.D, Principal investigator, Department of Gastroenterology, Ruijin HospitalQiang Zhao, MD, Ph.D, Principal investigator, Department of Cardiovascular Surgery, Ruijin HospitalYunpeng Zhu, MD, Study director, Department of Cardiovascular Surgery, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908593
- Sponsor's protocol ID
- IISR-2016-101603 (RJ)
- Acronym
- DACAB-GI-2
- Status last verified
- Aug 2023
- First submitted
- 5 Apr 2019
- Last updated
- 18 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu Y, Wang X, Yang Y, Liu L, Zhao Q, Yu L. Proton pump inhibitor in the prevention of upper gastrointestinal mucosal injury associated with dual antiplatelet therapy after coronary artery bypass grafting (DACAB-GI-2): study protocol for a randomized controlled trial. Trials. 2022 Jul 15;23(1):569. doi: 10.1186/s13063-022-06464-w.
PubMed 35840999
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Different Duration of a Proton Pump Inhibitor in the Prevention of Upper Gastrointestinal Mucosal Injury in Patients Taking 12-month Dual Antiplatelet Therapy After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT03908593
- Acronym / sponsor ID
- DACAB-GI-2 / IISR-2016-101603 (RJ)
- Keywords
- Gastrointestinal, Mucosal injury, Antiplatelet, Coronary artery bypass grafting, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 9 Apr 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 purpose of this study is to compare the efficacy and safety for 12- vs. 1-month of pantoprazole treatment in preventing dual antiplatelet therapy (DAPT)-related upper gastrointestinal mucosal injury after coronary artery bypass grafting (CABG).
To date, there has been no study using esophagogastroduodenoscopy (EGD) to compare the differences in upper gastrointestinal mucosal injury (including reflux esophagitis) after 6 and 12 months of PPI treatment combined with two different DAPT regimens (clopidogrel plus aspirin or ticagrelor plus aspirin).
Detailed description
This prospective trial was designed as a single-center, open-label, randomized controlled trial with patients allocated in a ratio of 1:1. Within 3 days after CABG, patients willing to participate in the study will be carefully evaluated by a cardiac surgeon together with a gastroenterologist based on inclusion and exclusion criteria. Patients will be followed up to 12 months post-randomization unless death. The outcome will be collected at 2±1 days, 9±2 days, 1 month, 3 months (phone call), 6 months, 9 months (phone call), and 12 months after CABG surgery, respectively. 13C urea breath testing is used to detect Helicobacter pylori (H. pylori) infection before enrollment. At 6 and 12 months post-randomization, routine laboratory tests and EGD will be performed respectively. Computed tomographic angiography (CTA) or coronary angiography (CAG) is also required at 12 months post-randomization.
Definition of end of the study
- The date on which the last subject completed the last follow-up was the endpoint of this study.
- During the follow-up period, if the patient's biopsy pathological report showed that EGD detects precancerous lesions (e.g., atypical hyperplasia, low-grade or high-grade internal neoplasia, etc.) or malignant lesions.
- Patients randomized to the control group (1-month pantoprazole treatment group) should continue PPI treatment if GERD-Q questionnaire score 8, endoscopic findings of reflux esophagitis (LA-A and above), gastroduodenal mucosal injury of modified Lanza score of 4, or upper gastrointestinal bleeding at any time during the follow-up period.
Following the ITT principle, all patients randomized in this study should be evaluated for primary and secondary endpoints regardless of changes in PPI treatment. Thus, patients in the 1-month pantoprazole treatment group required PPI treatment at any time after 1 month and could also be assessed for primary and secondary endpoints.
According to the results of the preliminary study, the cumulative incidence rate of severe gastric and duodenal bulb erosion and ulcers of the 1-month PPI treatment group is assumed to be 36%, and that of the 12-month PPI treatment group was assumed to be 18%. Based on a two-sided α of 0.05 and a randomization ratio of 1:1, a total of 186 subjects are required to provide a power of 80%. Considering a 20% drop-out rate, the sample size of 232 subjects was determined.
In this study, all subjects received pantoprazole treatment for at least 1 month after CABG. Due to the COVID-19 pandemic, some subjects are unable to return to the center for study drugs and/or follow-up 1 month after the randomization. Those subjects who are unable to receive subsequent randomization intervention, will be excluded from the modified full analysis set and not included in the effectiveness analysis. Considering the statistical power of the study, randomized subjects will be added until the effective randomized intervention number reaches the predetermined sample size.
Two subgroup analyses will be performed in this study, including (1) H. pylori infection: negative and positive; (2) DAPT: aspirin + clopidogrel and aspirin + ticagrelor.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One month of therapy | Active comparator | Drug: PantoprazolePantoprazole, 40mg, tablet, oral, once daily for 1 month |
| Twelve months of therapy | Experimental | Drug: PantoprazolePantoprazole, 40mg, tablet, oral, once daily for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Each patient should meet all of the inclusion criteria and none of the exclusion criteria for this study:
- Provision of signed informed consent prior to any study specific procedures.
- Male or female, age ≥ 18 years at the time of consent.
- Planned or initiated use of 12 months of DAPT (aspirin plus clopidogrel or aspirin plus ticagrelor) immediately following primary isolated elective CABG surgery.
Key exclusion criteria (13 listed)
- Patients should not enter the study if any of the following exclusion criteria are fulfilled.
- History of previous active peptic ulcer within 3 months prior to enrollment.
- Planned use of PPIs to treat acid-associated disorders (e.g. gastroesophageal reflux disease, GERD)
- Contraindications for aspirin, clopidogrel, ticagrelor and pantoprazole use (e.g. known allergy)
- Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices, that cannot be stopped for the course of the study.
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 |
|---|---|---|
| PantoprazoleAlso: PANTOLOC, Tablet from Takeda Pharmaceutical Company LimitedPantoprazole (40mg qd) will be concomitant used with DAPT | Drug | One month of therapy, Twelve months of therapy |
Primary outcome
Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD.
Time frame: within 12 months after randomization
Gastroduodenal erosions and ulcers will be assessed according to the Lanza Endoscopic Scoring System. Lanza score is a categorical score (0-4) and defined as follows: 0, normal; 1, mucosal hemorrhages only; 2, 1-2 erosions; 3, 3-10 erosions; 4, >10 erosions or an ulcer ≥3 mm. In addition, ≥1 ulcer with a diameter no less than 5mm will be grouped separately.
4 secondary outcomes
Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD.
Time frame: 6 months after randomization
Cumulative rate of patients with upper gastrointestinal bleeding (UGIB) according to the modified TIMI criteria.
Time frame: within 12 months after randomization
Percentage of patients with reflux esophagitis evaluated by EGD.
Time frame: 12 months after randomization
Percentage of patients with reflux esophagitis evaluated by EGD.
Time frame: 6 months after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2023.
- Derived from this study: PubMed 35840999Zhu Y, Wang X, Yang Y, Liu L, Zhao Q, Yu L. Proton pump inhibitor in the prevention of upper gastrointestinal mucosal injury associated with dual antiplatelet therapy after coronary artery bypass grafting (DACAB-GI-2): study protocol for a randomized controlled trial. Trials. 2022 Jul 15;23(1):569. doi: 10.1186/s13063-022-06464-w.
- Individual participant dataSharing planned: No
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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.
Lifen Yu, MD, Ph.D principal investigator
Department of Gastroenterology, Ruijin Hospital
Qiang Zhao, MD, Ph.D principal investigator
Department of Cardiovascular Surgery, Ruijin Hospital
Yunpeng Zhu, MD study director
Department of Cardiovascular Surgery, Ruijin Hospital
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 Pantoprazole in people with Gastrointestinal Ulcer (Peptic) or Erosion and Anti-Platelet Therapy, run by Ruijin 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 4 inclusion and 13 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 18 Aug 2023. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with gastroduodenal erosions and ulcers evaluated by EGD. (time frame: within 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908593, which also lists 1 linked publication.
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 18 Aug 2023.