Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34957
• EU PAS number:
  EUPAS23099
• Study ID:
  34957
• Official title and acronym:
  Treatment Pattern of NOACs (non-vitamin K oral anticoagulants) in Outpatient Users in Colombian Databases - TREND Colombia
• DARWIN EU® study:
  No
• Study countries:
  Colombia
• Study description:
  This 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
• Study status:
  Finalised

Research institutions and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Networks

Grupo de Investigación en Farmacoepidemiológica y Farmacovigilancia, Faculty of Health Sciences, Universidad Tecnológica de Pereira, Colombia

Study timelines

Date when funding contract was signed

Planned: 30/01/2018

Actual: 22/02/2018

Study start date

Planned: 28/02/2018

Actual: 28/02/2018

Date of final study report

Planned: 31/12/2018

Actual: 07/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

20104_TREND Colombia Protocol_ENCEPP

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only