Status:
UNKNOWN
Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Atrial Fibrillation
Frailty
Eligibility:
All Genders
65+ years
Brief Summary
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) ...
Detailed Description
Data sources of use for this study are: Medicare Database, Optum Database, and MarketScan Research Database. All data from years 2013-2020 (available data may vary depending on the database) will be a...
Eligibility Criteria
Inclusion
- Initiation of a NOAC or warfarin (day 0 is the initiation day)
- 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
- Contraindication to either drug in \[-183, 0\] days
- 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
Key Trial Info
Start Date :
March 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
1000000 Patients enrolled
Trial Details
Trial ID
NCT04878497
Start Date
March 30 2021
End Date
December 31 2022
Last Update
May 7 2021
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120