Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
Status unconfirmed
Conditions studied: Atrial Fibrillation, Frailty, Anticoagulant-induced Bleeding, Stroke
In brief
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.
Key facts
- Study ID
- NCT04878497
- Run by
- Brigham and Women's Hospital
- People needed
- 1000000
- Starts
- 2021-03-30
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2021-05-07
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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