Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
NCT ID: NCT04878497
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000000 participants
OBSERVATIONAL
2021-03-30
2022-12-31
Brief Summary
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Detailed Description
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This study follows a sequential cohort monitoring design. The monitoring analysis will include 1) retrospective analysis of available data (2013-2018) at the time of first analysis (April 2021) and 2) prospective analysis of new data (2019-2020) as they become available to the researchers. Within each database and by frailty status (frail vs non-frail), the investigators will emulate annual updating of data by creating a propensity score (PS)-matched cohort of new users every 1-year interval. Each sequential cohort will be followed for development of the outcomes of interest. At the end of each interval, time-to-event data from all sequential cohorts will be pooled for outcome analysis. The surveillance will be performed by frailty status (frail vs non-frail) at the time of drug initiation.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Warfarin
New users of warfarin
Warfarin
Initiation of warfarin, identified using prescription fill in pharmacy claims
Dabigatran
New users of dabigatran
Dabigatran
Initiation of dabigatran, identified using prescription fill in pharmacy claims
Rivaroxaban
New users of rivaroxaban
Rivaroxaban
Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
Apixaban
New users of apixaban
Apixaban
Initiation of apixaban, identified using prescription fill in pharmacy claims
Edoxaban
New users of edoxaban
Edoxaban
Initiation of edoxaban, identified using prescription fill in pharmacy claims
Interventions
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Warfarin
Initiation of warfarin, identified using prescription fill in pharmacy claims
Dabigatran
Initiation of dabigatran, identified using prescription fill in pharmacy claims
Rivaroxaban
Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
Apixaban
Initiation of apixaban, identified using prescription fill in pharmacy claims
Edoxaban
Initiation of edoxaban, identified using prescription fill in pharmacy claims
Eligibility Criteria
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Inclusion Criteria
* Continuous enrollment in medical and drug insurance in \[-183, 0\] days
* Diagnosis of AF in \[-183, 0\] days
* CHA2DS2-VASc score ≥2 (moderate or high risk for stroke)
* No prior use of NOAC or warfarin in \[-183, -1\] days
* No recent hospitalization for stroke or major bleeding in \[-60, 0\] days
* No recent nursing facility stay in \[-60, 0\] days
Exclusion Criteria
* Valvular heart disease or mechanical heart valve in \[-183, 0\] days
* Intracranial or retroperitoneal hemorrhage in \[-183, 0\] days
* Chronic kidney disease stage V, end-stage renal disease, or dialysis in \[-183, 0\] days
* Other indications for anticoagulation therapy in \[-183, 0\] days
65 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Dae Hyun Kim, MD, MPH, ScD
Associate Professor
Principal Investigators
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Dae Hyun Kim, MD, MPH, ScD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019P000110-NOAC
Identifier Type: -
Identifier Source: org_study_id
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