Anticoagulant Utilization Pattern

NCT ID: NCT01847560

Last Updated: 2019-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

333664 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-17

Study Completion Date

2017-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dabigatran

No interventions assigned to this group

Warfarin or other New Oral Anticoagulant (NOAC)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1160.177

Identifier Type: -

Identifier Source: org_study_id

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