Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe

Boehringer Ingelheim

Status: Completed

Conditions: Atrial Fibrillation

Study type: Observational

Funder types: Industry

Identifiers

NCT02240654

1160.144

Details and patient eligibility

About

This is a descriptive, observational, multi-country European cross-sectional study of new users of dabigatran etexilate that aims to characterise on- and off-label status and other medical characteristics at the time of the first captured prescription of dabigatran etexilate in each database. The study will be conducted using Cegedim Strategic Database (CSD, France), Danish National Databases (Denmark) and Clinical Practice Research Datalink (CPRD, UK).

Full description

Study Design:

Enrollment: 36,573 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Have at least 1 year of enrolment in the electronic database.
2. Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.

Trial design

36,573 participants in 1 patient group

Dabigatran etexilate