[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-hemorrhage-clinically-important-upper\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-hemorrhage-clinically-important-upper":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":5},"100631224","fenox-trial-comparative-effectiveness-of-fexuprazan-co-therapy-in-patients-receiving-non-vitamin-k-antagonist-oral-anticoagulants-100631224",false,"NCT07497893","FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)","FENOX Study (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)","FENOX","Inclusion Criteria:\n\n* Age ≥18 years\n* Documented non-valvular atrial fibrillation\n* Receiving or initiating therapy with a non-vitamin K antagonist oral anticoagulant (NOAC) at guideline-recommended dosing\n* At least one high-risk factor for upper gastrointestinal bleeding, including:\n\n  * Age ≥75 years\n  * Chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²)\n  * Concomitant antiplatelet therapy\n  * Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids\n  * Prior peptic ulcer disease or upper gastrointestinal bleeding\n  * HAS-BLED score ≥3\n\nExclusion Criteria:\n\n* Active gastrointestinal bleeding at the time of screening\n* Requirement for mandatory long-term proton pump inhibitor (PPI) therapy that cannot be discontinued\n* Severe hepatic dysfunction\n* Life expectancy \\\u003C1 year\n* Known hypersensitivity or contraindication to fexuprazan\n* Participation in another interventional clinical trial that may interfere with study outcomes","ALL","18 Years",{"count":20,"type":21},1000,"ESTIMATED","INTERVENTIONAL",[24],"NA","Background Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended for stroke prevention in non-valvular atrial fibrillation (AF). Although NOACs substantially reduce intracranial hemorrhage, upper gastrointestinal bleeding (UGIB) remains a frequent and clinically consequential complication. Proton pump inhibitors (PPIs) may reduce UGIB risk; however, concerns regarding long-term safety and pharmacodynamic variability persist. Fexuprazan, a potassium-competitive acid blocker (P-CAB), provides rapid and sustained acid suppression independent of acid activation and CYP2C19 metabolism. No randomized trial has evaluated P-CAB therapy for prevention of UGIB in anticoagulated patients.\n\nMethods FENOX is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) superiority trial. Approximately 1,000 high-risk patients with non-valvular AF initiating NOAC therapy will be randomized 1:1 to receive fexuprazan plus NOAC therapy or NOAC therapy alone. High-risk enrichment includes advanced age, renal impairment, concomitant antiplatelet therapy, prior ulcer disease, or elevated HAS-BLED score. The primary endpoint is clinically relevant upper gastrointestinal bleeding (CR-UGIB) at 12 months, defined according to ISTH criteria. All events will be adjudicated by an independent blinded Clinical Events Committee. Primary analyses will follow the intention-to-treat principle using time-to-event methods.\n\nResults The planned sample size provides 80% power to detect a 50% relative risk reduction in CR-UGIB, assuming a 12-month incidence of 10% in the control group. Interim safety monitoring will be conducted under independent oversight.\n\nConclusion FENOX is the first randomized trial designed to evaluate a P-CAB-based gastroprotective strategy for prevention of clinically relevant UGIB in high-risk patients receiving NOAC therapy. By integrating high-risk enrichment, pragmatic design, and blinded endpoint adjudication, the study aims to provide rigorous evidence to inform gastroprotective strategies in anticoagulated populations.",[27,28,29,30],"Atrial Fibrillation (AF)","Upper Gastrointestinal Bleeding (UGIB)","Gastrointestinal Hemorrhage (Clinically Important, Upper)","Drug-Related Side Effects and Adverse Reactions",[32],"Non-vitamin K antagonist oral anticoagulants (NOACs), potassium-competitive acid blocker (P-CAB), Upper gastrointestinal bleeding (UGIB)","NOT_YET_RECRUITING","2026-03-23",{"date":36,"type":37},"2026-03-27","ACTUAL",{"date":39,"type":21},"2026-12-01",{"date":41,"type":21},"2032-11-30",{"name":43,"class":44},"Ewha Womans University Mokdong Hospital","OTHER"]