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

NCT04878497 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000000

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Dae Hyun Kim, MD, MPH, ScD · Brigham and Women's Hospital

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-30
Primary Completion
2022-12-31
Completion
2022-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878497 on ClinicalTrials.gov