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

IISR-2016-101603 (RJ)

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).

2019-10-14

2023-12-30

2024-01-30

Active (not recruiting)

Early phase I

232

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 \[NSAIDs\])

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 232, 'type': 'ESTIMATED'}}

2023-08-18