Anticoagulant Utilization Pattern

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01847560
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : December 5, 2017
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease
Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 333664 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation
Actual Study Start Date : April 17, 2013
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Warfarin
U.S. FDA Resources

Warfarin or other NOACs

Primary Outcome Measures :
  1. Proportion of patients dispensed specific anticoagulants and anticoagulant doses (for new oral anticoagulant medications) [ Time Frame: up to 6 years ]
  2. Description of the characteristics of patients with non-valvular atrial fibrillation initiating oral anticoagulants [ Time Frame: up to 6 years ]

Secondary Outcome Measures :
  1. Treatment persistence over time [ Time Frame: up to 6 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Inclusion criteria:

  • A recorded diagnosis of atrial fibrillation
  • Initiation of oral anticoagulant medication
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01847560

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT01847560     History of Changes
Other Study ID Numbers: 1160.177
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes