NCT02240654

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36,573

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 16, 2017

Completed
Last Updated

December 15, 2017

Status Verified

November 1, 2017

Enrollment Period

1.5 years

First QC Date

September 15, 2014

Results QC Date

May 18, 2017

Last Update Submit

November 6, 2017

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Potential Off-label Use Estimated Among New Users of Dabigatran Etexilate in Each of the Data Sources.

    Definition of off-label use of oral dabigatran etexilate (DE) was based on use for a disease/medical condition other than labelled indications,as described/documented in the data source used in the respective countries, taking into account the changes in the label within the study period. The prevalence of potential off-label use among new users of DE during the overall study period is calculated as the proportion of patients meeting the definition of off-label use by dividing the number of index prescriptions that represented off-label use by the total number of index prescriptions. Two definitions were applied to estimate potential off-label use based on either recorded diagnoses or proxies: a broad definition of on-label prescribing using codes for disease indication e.g.atrial fibrillation(AF) and a restrictive definition excluding patients with conditions for which the drug is not indicated e.g.valvular AF. SPAF:Stroke \& systemic embolism in adult patients with non-valvular AF

    Time period since approval of the SPAF indication in, France: 01 August 2011 to 30 June 2014; Denmark: 01 August 2011 to 30 November 2013; UK: 01 August 2011 to 30 August 2015.

Study Arms (1)

Dabigatran etexilate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

New users of dabigatran etexilate in each database

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1160.144.1 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

Related Publications (1)

  • Cainzos-Achirica M, Varas-Lorenzo C, Pottegard A, Asmar J, Plana E, Rasmussen L, Bizouard G, Forns J, Hellfritzsch M, Zint K, Perez-Gutthann S, Pladevall-Vila M. Methodological challenges when evaluating potential off-label prescribing of drugs using electronic health care databases: A case study of dabigatran etexilate in Europe. Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):713-723. doi: 10.1002/pds.4416. Epub 2018 Mar 23.

    PMID: 29570897DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

Clinical information being highly variable across countries was likely to be major driver of different proportions.UK(HES link) is likely to provide most accurate estimate(France and DK data need to be interpreted cautiously because of limited info)

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2014

First Posted

September 16, 2014

Study Start

November 28, 2014

Primary Completion

May 20, 2016

Study Completion

May 20, 2016

Last Updated

December 15, 2017

Results First Posted

October 16, 2017

Record last verified: 2017-11

Locations

ES(1)