[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650493":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":20,"responsibleParty":49,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":10,"eligibilityCriteria":63,"healthyVolunteers":60,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Chulalongkorn University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Asian Atrial Fibrillation Apixaban Cohort",null,"The study group comprises Asian patients diagnosed with non-valvular atrial fibrillation who are receiving apixaban as part of their standard clinical care. To ensure valid pharmacokinetic analysis, all participants must have reached a steady-state drug concentration, defined as receiving a fixed dose of 2.5 mg or 5 mg twice daily for at least three consecutive days. The group includes patients from two major tertiary centers: King Chulalongkorn Memorial Hospital in Thailand and National Taiwan University Hospital in Taiwan.\n\nThis cohort is characterized by two levels of data density: an intensive sampling subgroup (n=24) and a sparse sampling subgroup (n=180). As this is a retrospective observational study, no experimental intervention is administered; the \"intervention\" of interest is the standard therapeutic exposure to apixaban, which is analyzed to identify the impact of clinical covariates such as renal function, body weight, and drug-drug interactions.",[13],"Drug: Apixaban",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Apixaban","Apixaban is administered as an oral tablet in fixed doses of 2.5 mg or 5 mg twice daily. The intervention is provided as part of standard clinical care for patients diagnosed with non-valvular atrial fibrillation. For the purposes of this pharmacokinetic analysis, the intervention requires a minimum duration of 3 consecutive days of consistent dosing to ensure that the drug has reached steady-state plasma concentrations prior to data collection.",[9],[21],{"facility":22,"status":10,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"Faculty of Medicine, Chulalongkorn University","Pathum Wan","Bangkok","10330","Thailand","TH",{"type":29,"coordinates":30},"Point",[31,32],100.52329,13.73698,{"lat":32,"lon":31},[35,41,46],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Pheeraphat Sarppreuttikun, PharmD","CONTACT","66-02-986-9214 to 19","4406","pheephar@tu.ac.th",{"name":42,"role":37,"phone":43,"phoneExt":44,"email":45},"Somratai Vadcharavivad, P้h.D","+662-218-8403","28","somratai.v@pharm.chula.ac.th",{"name":47,"role":48,"phone":10,"phoneExt":10,"email":10},"Pisut Katavetin, MD","SUB_INVESTIGATOR",{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":53,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Pheeraphat Sarppreuttikun","Lecturer","Thammasat University",[55,56],{"name":53,"class":6},{"name":57,"class":6},"King Chulalongkorn Memorial Hospital","100650493","population-pharmacokinetics-of-apixaban-in-asian-patients-with-atrial-fibrillation-100650493",false,"NCT07747948","Population Pharmacokinetics of Apixaban in Asian Patients With Atrial Fibrillation","Inclusion Criteria:\n\n* Age 18 years and older\n* Patients diagnosed with atrial fibrillation\n* Receiving apixaban at a fixed dose of 2.5 mg or 5 mg twice daily for at least 3 consecutive days\n\nExclusion Criteria:\n\n* Patients with end-stage renal disease (ESRD) receiving renal replacement therapy\n* Patients with a history of acute kidney injury (AKI) within 3 months prior to study enrollment\n* Patients with cirrhosis of Child-Pugh class C severity\n* Patients receiving moderate to strong inhibitors or inducers of CYP3A4 or P-glycoprotein (P-gp), such as ketoconazole, itraconazole, voriconazole, posaconazole, ritonavir, naproxen, clarithromycin, rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's Wort (Patients receiving amiodarone, verapamil, or diltiazem are not excluded and will be included for covariate analysis)\n* Patients with gastrointestinal disorders that significantly affect drug absorption, such as short bowel syndrome","ALL","18 Years",{"count":67,"type":68},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn about the variability of apixaban blood levels and identify the clinical factors that influence them in Asian patients with atrial fibrillation. The main questions it aims to answer are:\n\n1. What are the specific pharmacokinetic parameters and their variabilities for apixaban in this patient population?\n2. Which clinical factors, such as kidney function or body weight, are the primary predictors of how apixaban is cleared and distributed in the body?\n\nParticipants will be asked to give consent to allow researchers to use their existing electronic outpatient medical records and previously collected blood concentration data for analysis.",[72],"Non Valvular Atrial Fibrillation (nv AF)",[17,74,75,76,77],"Atrial Fibrillation","Pharmacokinetics","Asian","Anticoagulants","NOT_YET_RECRUITING","2026-08-04",{"date":81,"type":82},"2026-08-05","ACTUAL",{"date":84,"type":68},"2026-09-01",{"date":86,"type":68},"2027-04-30",{"name":5,"class":6},1]