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Anticoagulant Utilization Pattern

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01847560
First received: April 18, 2013
Last updated: November 12, 2014
Last verified: November 2014
  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 ] [ Designated as safety issue: No ]
  • Description of the characteristics of patients with non-valvular atrial fibrillation initiating oral anticoagulants [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment persistence over time [ Time Frame: up to 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100000
Study Start Date: April 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dabigatran
Warfarin or other NOACs

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01847560

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Massachusetts
1160.177.01001 Boehringer Ingelheim Investigational Site Recruiting
Boston, Massachusetts, United States
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01847560     History of Changes
Other Study ID Numbers: 1160.177
Study First Received: April 18, 2013
Last Updated: November 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014