The Comparative Safety and Effectiveness of Warfarin and Dabigatran Prescribed in the Non-valvular Atrial Fibrillation Population With Humana Healthcare Coverage

• Status: Completed
• Trial end date: 2016-03-15
• Target enrollment: 0
• Participant gender: All

Summary

This study is an opportunity for Boehringer Ingelheim to collaborate with Humana to conduct comparative safety and effectiveness studies of dabigatran and warfarin using real world data from Humana's health plan operations.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Dabigatran; Warfarin

Criteria

Inclusion criteria:

• Patient must have at least one inpatient, one physician office visit, or one emergency room visit with a diagnosis of AF on the index date or during the pre-index period.

• Patients must be continuously enrolled in a health plan during the pre-index period

• Patient must have a prescription for dabigatran or warfarin

• Patient must be treatment naive from all oral anticoagulant (OAC) use prior to first OAC prescription

• Aged 18-89 years on the index date. The index date is defined as the date of the first OAC prescription

Exclusion criteria:

• Diagnosis of hyperthyroidism during the pre-index period,

• Having claims for any of the following within 3 months prior to the first diagnosis of AF: cardiac surgery, pericarditis, myocarditis, pulmonary embolism.

• Any patients with at least one medical claim for valvular heart disease.