NCT04878497

Prospective Monitoring of Non-Vitamin K Oral Anticoagulants in Older Adults With Atrial Fibrillation and Frailty

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000,000 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation
• Frailty
• Anticoagulant-induced Bleeding
• Stroke

Interventions

Type	Name	Description
DRUG	Warfarin	Initiation of warfarin, identified using prescription fill in pharmacy claims
DRUG	Dabigatran	Initiation of dabigatran, identified using prescription fill in pharmacy claims
DRUG	Rivaroxaban	Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
DRUG	Apixaban	Initiation of apixaban, identified using prescription fill in pharmacy claims
DRUG	Edoxaban	Initiation of edoxaban, identified using prescription fill in pharmacy claims

Timeline

• Start date: 2021-03-30
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-05-07
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study