[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631224":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":26,"enrollmentInfo":65,"targetDuration":26,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":77,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Ewha Womans University Mokdong Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Fexuprazan plus NOAC therapy","EXPERIMENTAL","Participants will receive fexuprazan 40 mg orally once daily in addition to standard-of-care non-vitamin K antagonist oral anticoagulant (NOAC) therapy at guideline-recommended dosing.",[13,14],"Drug: Fexuprazan","Drug: NOAC therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"NOAC therapy alone","ACTIVE_COMPARATOR","Participants will receive standard-of-care non-vitamin K antagonist oral anticoagulant (NOAC) therapy at guideline-recommended dosing without additional gastroprotective therapy.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fexuprazan","Fexuprazan 40 mg administered orally once daily for the duration of the study in combination with NOAC therapy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"NOAC therapy","Non-vitamin K antagonist oral anticoagulant therapy (e.g., apixaban, rivaroxaban, dabigatran, or edoxaban) administered according to approved labeling and guideline-recommended dosing.",[9,16],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Yeji Kim MD, PhD","CONTACT","+82-10-8680-9542","lexie6169@gmail.com",[38],{"facility":5,"status":26,"city":39,"state":26,"zip":40,"country":41,"countryCode":26,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Seoul","1071","South Korea",{"type":43,"coordinates":44},"Point",[45,46],126.9784,37.566,{"lat":46,"lon":45},[49],{"name":50,"role":34,"phone":51,"phoneExt":26,"email":52},"Junbeom Park, PhD","+82-02-3539-9822","newriser@naver.com",{"type":54,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":66,"type":67},1000,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73,74,75,76],"Atrial Fibrillation (AF)","Upper Gastrointestinal Bleeding (UGIB)","Gastrointestinal Hemorrhage (Clinically Important, Upper)","Drug-Related Side Effects and Adverse Reactions",[78],"Non-vitamin K antagonist oral anticoagulants (NOACs), potassium-competitive acid blocker (P-CAB), Upper gastrointestinal bleeding (UGIB)","NOT_YET_RECRUITING","2026-03-23",{"date":82,"type":83},"2026-03-27","ACTUAL",{"date":85,"type":67},"2026-12-01",{"date":87,"type":67},"2032-11-30",{"name":5,"class":6},1]