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

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT02043808

1160.183

Details and patient eligibility

About

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

Full description

Study Design:

Retrospective

Enrollment: 25,586 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

25,586 participants in 2 patient groups

Dabigatran

Warfarin