[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ewha Womans University Mokdong Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":137},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,78,106],{"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":45},"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",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":45},"100631100","phase-4-optia-af-trial-rhythm-guided-antithrombotic-strategy-after-af-ablation-100631100","NCT07496281","OPTIA-AF Trial: Rhythm-Guided Antithrombotic Strategy After AF Ablation","OPTIA-AF Trial: A Randomized Study of Rhythm-Guided Antithrombotic Strategy After Atrial Fibrillation Ablation in Patients With Prior Drug-Eluting Stent Implantation","OPTIA-AF","1. Inclusion Criteria\n\n   * Participants must meet all of the following criteria:\n   * Age ≥18 years.\n   * Documented history of atrial fibrillation (paroxysmal or persistent).\n   * Successful catheter ablation for atrial fibrillation performed within the previous 3-6 months.\n   * Maintenance of sinus rhythm after ablation, confirmed by follow-up electrocardiography or rhythm monitoring.\n   * History of percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation.\n   * Completion of the recommended duration of dual antiplatelet therapy (DAPT) following PCI.\n   * Currently receiving oral anticoagulation therapy with a non-vitamin K antagonist oral anticoagulant (NOAC).\n   * Clinically stable and considered eligible for long-term antithrombotic therapy adjustment by the treating physician.\n   * Ability to understand the study procedures and provide written informed consent.\n2. Exclusion Criteria\n\n   * Participants will be excluded if any of the following criteria are present:\n   * Recurrent atrial fibrillation documented after the index ablation procedure requiring repeat ablation or antiarrhythmic escalation.\n   * Presence of mechanical heart valve or moderate-to-severe mitral stenosis.\n   * Indication for long-term anticoagulation independent of atrial fibrillation (e.g., venous thromboembolism, mechanical valve).\n   * Recent acute coronary syndrome or PCI within the past 3 months.\n   * Planned coronary revascularization or cardiac surgery.\n   * History of intracranial hemorrhage or other major bleeding that contraindicates antithrombotic therapy.\n   * Severe renal dysfunction (e.g., estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m²).\n   * Severe hepatic dysfunction associated with coagulopathy.\n   * Known hypersensitivity or contraindication to aspirin or NOAC therapy.\n   * Pregnancy or breastfeeding.\n   * Life expectancy less than 1 year due to non-cardiovascular comorbidities.\n   * Participation in another interventional clinical trial that may interfere with the study outcomes.",{"count":55,"type":21},2,[57],"PHASE4","The OPTIA-AF trial is a prospective, multicenter randomized controlled trial designed to evaluate a rhythm-guided antithrombotic strategy in patients with atrial fibrillation (AF) who maintain durable sinus rhythm after catheter ablation and have a history of prior drug-eluting stent (DES) implantation. Current guidelines generally recommend long-term oral anticoagulation (OAC) in patients with AF, even after successful ablation, while antiplatelet therapy remains essential for prevention of coronary ischemic events following percutaneous coronary intervention.\n\nOPTIA-AF tests whether discontinuation of non-vitamin K antagonist oral anticoagulant (NOAC) therapy with transition to single antiplatelet therapy (SAPT) is non-inferior to continued NOAC therapy in patients who maintain sinus rhythm for at least 12 months after AF ablation. Participants will be randomized in a 1:1 ratio to either continued NOAC therapy or NOAC discontinuation with SAPT.\n\nThe primary endpoint is a 24-month composite net clinical outcome including ischemic stroke, systemic embolism, myocardial infarction, definite or probable stent thrombosis, cardiovascular death, and major bleeding.",[27,60,61],"Coronary Artery Disease","Drug-eluting Stent",[63,64,65,66,67,68,69,70,71],"Atrial fibrillation ablation","Antithrombotic therapy","Oral anticoagulation","Non-vitamin K antagonist oral anticoagulant","Single antiplatelet therapy","Drug-eluting stent","Rhythm-guided strategy","Catheter ablation","Randomized controlled trial",{"date":36,"type":37},{"date":74,"type":21},"2027-03-01",{"date":76,"type":21},"2035-03-01",{"name":43,"class":44},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":18,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":45},"100587554","pvi-alone-vs-pvi-with-posterior-wall-isolation-for-pulse-field-ablation-in-persistent-af-100587554","NCT06929897","PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF","Comparison of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation With Posterior Wall Isolation for Pulse-Field Ablation in Persistent Atrial Fibrillation: A Prospective Randomized Controlled Trial","POBI-PFA","Inclusion Criteria:\n\n* Patients eligible for catheter ablation according to existing clinical guidelines\n* Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)\n* Those without contraindications to anticoagulation therapy\n\nExclusion Criteria:\n\n* Atrial fibrillation associated with severe congenital heart disease or structural heart disease\n* Patients with contraindications to general anesthesia or sedation for the procedure\n* History of prior cardiac surgery (e.g., Maze procedure, coronary artery bypass grafting)\n* History of atrial fibrillation catheter ablation within the past 12 months\n* Patients with severe left ventricular dysfunction (left ventricular ejection fraction \\\u003C30%)\n* Patients with active internal bleeding\n* Patients with contraindications to anticoagulation therapy and antiarrhythmic drugs\n* Valvular atrial fibrillation (e.g., mitral stenosis \\> grade 2, mechanical valve, prior mitral valve repair)\n* Patients with severe comorbid conditions\n* Patients with an expected survival of less than one year\n* Patients with drug or alcohol addiction\n* Pregnant or breastfeeding women\n* Any other conditions deemed by the investigator to make the patient unsuitable for study participation",true,"80 Years",{"count":89,"type":21},214,[24],"To date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in several studies, and its clinical application is expanding.\n\n\\- In patients with persistent atrial fibrillation, can the addition of posterior wall isolation (PWI) following pulmonary vein isolation (PVI) using PFA reduce recurrence?\n\nParticipants will:\n\n* Undergo either PVI alone or PVI with additional left atrial posterior wall isolation (PWI)\n* Visit the clinic to assess for recurrence of atrial tachyarrhythmias",[27],[94,95,96,97],"pulsed field ablation","catheter ablation","posterior wall isolation","atrial fibrillation","2025-04-08",{"date":100,"type":37},"2025-04-16",{"date":102,"type":21},"2025-05-01",{"date":104,"type":21},"2027-10-01",{"name":43,"class":44},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":86,"sex":17,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":116,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":124,"overallStatus":127,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100584475","korean-joint-registry-for-alzheimers-treatment-and-diagnostics-joy-alz-100584475","NCT06889818","Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)","JOY-ALZ","Inclusion Criteria:\n\n1. Participants must be 19 years of age or older at the time of informed consent.\n2. Patients who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, patients who have decided to initiate treatment with these medications in consultation with their physician after 2021, or patients who have already started treatment with newly approved Alzheimer's disease medications after 2021.\n3. Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181.\n4. Clinical diagnosis of Alzheimer's disease, defined as follows:\n\n\u003C!-- -->\n\n1. \\[Alzheimer's Disease Dementia (ADD)\\] - Must meet the criteria for probable Alzheimer's dementia as defined by the National Institute on Aging and the Alzheimer's Association working groups (NIA-AA).\n\n   * Must exhibit cognitive decline that impairs independent daily living.\n2. \\[Mild Cognitive Impairment (MCI)\\]\n\n   \\- Must meet NIA-AA diagnostic criteria for MCI.\n\n   \\- The subject or informant must report cognitive decline.\n\n   \\- Performance on delayed recall of verbal memory must be more than -1.0 SD below the age- and education-adjusted normative mean, or scores on any one or more tests of executive function, language, visuospatial abilities, or attention must be more than -1.5 SD below the age- and education-adjusted normative mean.\n\n   \\- Clinical Dementia Rating scale (CDR) of 0.5.\n\n   \\- Maintenance of independent daily living ability.\n\n   \\- Not categorized as dementia.\n3. \\[Cognitively Unimpaired (CU)\\]\n\n   \\- Delayed recall of verbal memory must be at or above -1.0 SD versus the age- and education-adjusted normative mean, and all executive function, language, visuospatial abilities, and attention tests must be at or above -1.5 SD versus the age- and education-adjusted normative mean.\n\n   \\- Maintenance of independent daily living ability.\n   * If the subject reports cognitive decline, they will be classified as having Subjective Cognitive Decline (SCD).\n\n     5\\. Patients must be ambulatory (use of mobility aids is acceptable). 6. The subject must provide written informed consent to participate in the study. In the case of dementia patients, additional written consent from a guardian is required.\n\nExclusion Criteria:\n\n1. Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc.\n2. History of substance abuse or alcohol dependence that required treatment within the past five years.\n3. A current diagnosis of cancer that has not achieved remission within the past five years. However, localized prostate cancer, cervical carcinoma in situ, non-melanoma skin basal cell carcinoma, or squamous cell carcinoma are excluded.\n4. Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease).\n5. Visual or auditory impairments that prevent the satisfactory assessment of cognitive function.\n6. Inability to perform MRI due to the presence of metallic substances in the body.\n7. Currently participating in another drug clinical trial.\n8. Currently pregnant or breastfeeding.","19 Years",{"count":115,"type":21},4000,"10 Years","OBSERVATIONAL","The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to evaluate the impact of these new therapies and diagnostic techniques in clinical practice.",[120,121,122,123],"Mild Cognitive Impairment","Dementia","Subjective Cognitive Decline (SCD)","Alzheimer Disease",[125,126],"Real World Data","Lecanemab","RECRUITING","2025-03-17",{"date":130,"type":37},"2025-03-21",{"date":132,"type":37},"2025-02-24",{"date":134,"type":21},"2034-12-31",{"name":43,"class":44},3,""]