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Anticoagulant Utilization Pattern

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01847560
First Posted: May 7, 2013
Last Update Posted: December 5, 2017
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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
Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

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

Enrollment: 333664
Actual Study Start Date: April 17, 2013
Study Completion Date: November 1, 2017
Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dabigatran
Warfarin or other NOACs

  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01847560


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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01847560     History of Changes
Other Study ID Numbers: 1160.177
First Submitted: April 18, 2013
First Posted: May 7, 2013
Last Update Posted: December 5, 2017
Last Verified: December 2017

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