Clinical trial NCT04878497: Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
Official title: Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Frailty
Anticoagulant-induced Bleeding
Stroke
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 1000000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population includes older patients with non-valvular AF who initiates warfarin or a NOAC.

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) 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.

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 analyzed in the study.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of patients with composite events of stroke or systemic embolism
timeFrame: January 2013 - December 2020 (after drug initiation)
measure: Number of patients with major bleeding
timeFrame: January 2013 - December 2020 (after drug initiation)
Secondary outcomes:
measure: Number of patients with all-cause mortality
timeFrame: January 2013 - December 2020 (after drug initiation)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Dae Hyun Kim, MD, MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References: