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Anticoagulant Utilization Pattern

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01847560
First received: April 18, 2013
Last updated: August 8, 2017
Last verified: August 2017
  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 ]

Estimated Enrollment: 99999
Actual Study Start Date: April 17, 2013
Estimated Study Completion Date: August 9, 2017
Estimated Primary Completion Date: August 9, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dabigatran
Warfarin or other NOACs

  Eligibility

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
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
Brigham and Women's Hospital Recruiting
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
Study First Received: April 18, 2013
Last Updated: August 8, 2017

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

ClinicalTrials.gov processed this record on August 23, 2017