The Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-Valvular Atrial Fibrillation Population With DoD Healthcare Coverage

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

25586 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-05-31

Brief Summary

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The objective is to assess the safety and effectiveness of new dabigatran and warfarin patients diagnosed with NVAF in the US DoD population.

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Detailed Description

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Study Design:

Retrospective

Conditions

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Atrial Fibrillation

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Dabigatran

No interventions assigned to this group

Warfarin

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients must be continuously enrolled in a health plan during the pre-index period;
* Patients must have at least one inpatient, or one physician office visit, emergency room visit with a diagnosis of AF (ICD-9-CM diagnosis code: 427.31in any position) on the index date or during the pre-index period;
* Patients must have a prescription for dabigatran or warfarin (this first prescription will be the index date);
* Patients must be treatment naive from all OAC use prior to first dabigatran or warfarin prescription;
* Aged 18-89 on the index date;

Exclusion Criteria

* Patients with valvular procedures related to the baseline AF diagnosis will be excluded;
* Patients with transient causes of AF such as hyperthyroidism, any cardiac surgery, pericarditis, mycoarditis, pulmonary embolism within 3 months prior to their first diagnosis of AF;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No