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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04878497
• Other study ID #: 2019P000110-NOAC
• Status: Active, not recruiting
• Start date: March 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Warfarin
Initiation of warfarin, identified using prescription fill in pharmacy claims
• Dabigatran
Initiation of dabigatran, identified using prescription fill in pharmacy claims
• Rivaroxaban
Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
• Apixaban
Initiation of apixaban, identified using prescription fill in pharmacy claims
• Edoxaban
Initiation of edoxaban, identified using prescription fill in pharmacy claims

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with composite events of stroke or systemic embolism	Stroke OR systemic embolism, identified by relevant diagnoses in the claims data	January 2013 - December 2020 (after drug initiation)
Primary	Number of patients with major bleeding	Major bleeding, identified by relevant diagnoses in the claims data	January 2013 - December 2020 (after drug initiation)
Secondary	Number of patients with all-cause mortality	All-cause mortality is defined by the National Death Index file or vital status information in the claims data.	January 2013 - December 2020 (after drug initiation)