Anticoagulant Utilization Pattern

March 26, 2019 updated by: Boehringer Ingelheim

A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation

This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance database.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

333664

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation

Description

Inclusion criteria:

  • A recorded diagnosis of atrial fibrillation
  • Initiation of oral anticoagulant medication
  • Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score >=1
  • At least 18 years of age on the date of anticoagulant initiation

Exclusion criteria:

  • Patients with missing or ambiguous age or sex information
  • Patients with documented evidence of valvular disease
  • Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
  • Patients with prior use of any oral anticoagulant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Dabigatran
Warfarin or other New Oral Anticoagulant (NOAC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the Characteristics of Anticoagulant Initiators
Time Frame: From January 2009 to September 2015 (The study period)
The analyses described the characteristics of patients treated with various oral anticoagulants. CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant
Time Frame: From January 2009 to September 2015 (The study period)
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage. This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users. The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm. Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm. Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
Time Frame: From January 2009 to September 2015 (The study period)
Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
Time Frame: From January 2009 to September 2015 (The study period)
Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
From January 2009 to September 2015 (The study period)
Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
Time Frame: From January 2009 to September 2015 (The study period)
Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented. Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
From January 2009 to September 2015 (The study period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Persistence Over Time
Time Frame: From January 2009 to September 2015 (The study period)
Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort. Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.
From January 2009 to September 2015 (The study period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (Estimate)

May 7, 2013

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.177

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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