Coronary Artery Bypass Clinical Trial
— DACAB-GI-2Official 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
Verified date | August 2023 |
Source | Ruijin Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 232 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Each patient should meet all of the inclusion criteria and none of the exclusion criteria for this study: 1. Provision of signed informed consent prior to any study specific procedures. 2. Male or female, age = 18 years at the time of consent. 3. Planned or initiated use of 12 months of DAPT (aspirin plus clopidogrel or aspirin plus ticagrelor) immediately following primary isolated elective CABG surgery. Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled. 1. History of previous active peptic ulcer within 3 months prior to enrollment. 2. Planned use of PPIs to treat acid-associated disorders (e.g. gastroesophageal reflux disease, GERD) 3. Contraindications for aspirin, clopidogrel, ticagrelor and pantoprazole use (e.g. known allergy) 4. 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 - CYP3A4 substrates with narrow therapeutic index: quinidine, simvastatin at doses > 40mg daily or lovastatin at doses > 40mg daily. 5. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin. 6. 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. 7. 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. 8. Any condition outside the atherothrombotic study area with a life expectancy of less than 1 year. 9. 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. 10. 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]) |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cumulative rate of patients with major adverse cardiovascular events (MACE). | MACE: composite of cardiovascular death, myocardial infarctions, or stroke. | up to 12 months | |
Other | The failure rate of grafts assessed by computed tomographic angiography or coronary angiography. | Graft failure was assessed according to the modified Fitzgibbon classification: Stenosis =50% or occlusion of the graft or distal anastomosis (type B or O) | up to 12 months | |
Other | Cumulative rate of patients with all-cause death | All-cause death: Death from all causes during the follow-up. | up to 12 months | |
Primary | 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. | within 12 months after randomization | |
Secondary | 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. | 6 months after randomization | |
Secondary | 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). | within 12 months after randomization | |
Secondary | 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. | 12 months after randomization | |
Secondary | 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. | 6 months after randomization |
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