Status: Finalised First registered on: 13/03/2018
Last updated on: 27/04/2020
1. Study identification
EU PAS Register NumberEUPAS23099
Official titleTreatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases
Study title acronymTREND
Study typeObservational study
Brief description of the studyThis population-based descriptive study will characterize first-time users of three NOACs (rivaroxaban, dabigatran and apixaban) in prevention of stroke in non-valvular atrial fibrillation (SPAF) patients and will assess the patterns of drug utilization in routine general practice in Colombia
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Non-EU RMP only
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCEIFE
Department/Research groupFundación Centro Español de Investigación Farmacoepidemiológica
Organisation/affiliationFundación CEIFE
Website/Homepagewww.ceife.es
Details of (Primary) lead investigator
Title Dr
Last name García Rodríguez
First name Luis Alberto
Is this study being carried out with the collaboration of a research network?
Yes
Grupo de Investigación en Farmacoepidemiológica y Farmacovigilancia, Faculty of Health Sciences, Universidad Tecnológica de Pereira, Colombia
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Colombia
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed30/01/201822/02/2018
Start date of data collection28/02/201828/02/2018
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/201807/05/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer AG100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name García Rodríguez
First name Luis Alberto
Address line 1Almirante 28
Address line 2 
Address line 3 
CityMadrid 
Postcode28004 
CountrySpain
Phone number (incl. country code)34915313404 
Alternative phone number 
Fax number (incl. country code)34915312871 
Email address lagarcia@ceife.es
Public Enquiries
Title Dr 
Last name Bayer AG 
First name Bayer Clinical Trials 
Address line 1Muellerstrasse 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayer.com 
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