N/A
Completed N=36,573
Evaluation of Potential Off-label Use of Dabigatran Etexilate in Europe
Source: ClinicalTrials.gov NCT02240654 ↗Enrolled (actual)
36,573
Serious AEs
—
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. — 24.1; 34.0; 17.1; 5.7 percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources. |
24.1; 34.0; 17.1; 5.7; 11.5; 37.5 | — |
Eligibility Criteria
Inclusion criteria
- Have at least 1 year of enrolment in the electronic database.
- Have not been prescribed dabigatran etexilate during the 1-year period prior to the index date.
Data sourced from ClinicalTrials.gov (NCT02240654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.