[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429932":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":51,"centralContacts":10,"locations":55,"responsibleParty":68,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":10,"eligibilityCriteria":75,"healthyVolunteers":72,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":10,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Brigham and Women's Hospital","OTHER",[8,14,19,24,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Warfarin",null,"New users of warfarin",[13],"Drug: Warfarin",{"label":15,"type":10,"description":16,"interventionNames":17},"Dabigatran","New users of dabigatran",[18],"Drug: Dabigatran",{"label":20,"type":10,"description":21,"interventionNames":22},"Rivaroxaban","New users of rivaroxaban",[23],"Drug: Rivaroxaban",{"label":25,"type":10,"description":26,"interventionNames":27},"Apixaban","New users of apixaban",[28],"Drug: Apixaban",{"label":30,"type":10,"description":31,"interventionNames":32},"Edoxaban","New users of edoxaban",[33],"Drug: Edoxaban",[35,39,42,45,48],{"type":36,"name":9,"description":37,"armGroupLabels":38,"otherNames":10},"DRUG","Initiation of warfarin, identified using prescription fill in pharmacy claims",[9],{"type":36,"name":15,"description":40,"armGroupLabels":41,"otherNames":10},"Initiation of dabigatran, identified using prescription fill in pharmacy claims",[15],{"type":36,"name":20,"description":43,"armGroupLabels":44,"otherNames":10},"Initiation of rivaroxaban, identified using prescription fill in pharmacy claims",[20],{"type":36,"name":25,"description":46,"armGroupLabels":47,"otherNames":10},"Initiation of apixaban, identified using prescription fill in pharmacy claims",[25],{"type":36,"name":30,"description":49,"armGroupLabels":50,"otherNames":10},"Initiation of edoxaban, identified using prescription fill in pharmacy claims",[30],[52],{"name":53,"affiliation":5,"role":54},"Dae Hyun Kim, MD, MPH, ScD","PRINCIPAL_INVESTIGATOR",[56],{"facility":5,"status":10,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":10},"Boston","Massachusetts","02120","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-71.05977,42.35843,{"lat":66,"lon":65},{"type":54,"investigatorFullName":53,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Associate Professor","100429932","prospective-monitoring-of-non-vitamin-k-oral-anticoagulants-in-older-adults-with-atrial-fibrillation-and-frailty-100429932",false,"NCT04878497","Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty","Inclusion Criteria:\n\n* Initiation of a NOAC or warfarin (day 0 is the initiation day)\n* Continuous enrollment in medical and drug insurance in \\[-183, 0\\] days\n* Diagnosis of AF in \\[-183, 0\\] days\n* CHA2DS2-VASc score ≥2 (moderate or high risk for stroke)\n* No prior use of NOAC or warfarin in \\[-183, -1\\] days\n* No recent hospitalization for stroke or major bleeding in \\[-60, 0\\] days\n* No recent nursing facility stay in \\[-60, 0\\] days\n\nExclusion Criteria:\n\n* Contraindication to either drug in \\[-183, 0\\] days\n* Valvular heart disease or mechanical heart valve in \\[-183, 0\\] days\n* Intracranial or retroperitoneal hemorrhage in \\[-183, 0\\] days\n* Chronic kidney disease stage V, end-stage renal disease, or dialysis in \\[-183, 0\\] days\n* Other indications for anticoagulation therapy in \\[-183, 0\\] days","ALL","65 Years",{"count":79,"type":80},1000000,"ESTIMATED","OBSERVATIONAL","The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of non-vitamin K oral anticoagulants (NOAC) vs. a comparator, warfarin, in older adults with atrial fibrillation and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.",[84,85,86,87],"Atrial Fibrillation","Frailty","Anticoagulant-induced Bleeding","Stroke","UNKNOWN","2021-05-05",{"date":91,"type":92},"2021-05-07","ACTUAL",{"date":94,"type":92},"2021-03-30",{"date":96,"type":80},"2022-12-31",{"name":5,"class":6},1]