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

NCT04878497 | Unknown FDA Drug

• 1 other identifier: 2019P000110-NOAC
• Study Type: observational
• Target: 1,000,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Frailty; Anticoagulant-induced Bleeding; Stroke

Outcome Measures

Primary Outcomes (2)

• 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)

• Number of patients with major bleeding

  Major bleeding, identified by relevant diagnoses in the claims data

  January 2013 - December 2020 (after drug initiation)

Secondary Outcomes (1)

• Number of patients with all-cause mortality

  January 2013 - December 2020 (after drug initiation)

Study Arms (5)

Warfarin

New users of warfarin

Drug: Warfarin

Dabigatran

New users of dabigatran

Drug: Dabigatran

Rivaroxaban

New users of rivaroxaban

Drug: Rivaroxaban

Apixaban

New users of apixaban

Drug: Apixaban

Edoxaban

New users of edoxaban

Drug: Edoxaban

Interventions

Warfarin DRUG

Initiation of warfarin, identified using prescription fill in pharmacy claims

Warfarin

Dabigatran DRUG

Initiation of dabigatran, identified using prescription fill in pharmacy claims

Dabigatran

Rivaroxaban DRUG

Initiation of rivaroxaban, identified using prescription fill in pharmacy claims

Rivaroxaban

Apixaban DRUG

Initiation of apixaban, identified using prescription fill in pharmacy claims

Apixaban

Edoxaban DRUG

Initiation of edoxaban, identified using prescription fill in pharmacy claims

Edoxaban

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population includes older patients with non-valvular AF who initiates warfarin or a NOAC.

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Frailty; Stroke

Interventions

Warfarin; Dabigatran; Rivaroxaban; apixaban; edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyridines; Benzimidazoles; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Dae Hyun Kim, MD, MPH, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 7, 2021
• Study Start: March 30, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)