Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation (RELATE)

Study identification

• EU PAS number:
  EUPAS13390
• Study ID:
  26437
• Official title and acronym:
  Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa® or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation (RELATE)
• DARWIN EU® study:
  No
• Study countries:
  Indonesia

  Korea, Republic of

  Malaysia

  Singapore

  Thailand

  Viet Nam
• Study description:
  The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 50 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 16/05/2016

Actual: 03/06/2016

Study start date

Planned: 05/06/2016

Actual: 24/06/2016

Data analysis start date

Planned: 11/01/2018

Actual: 22/01/2018

Date of final study report

Planned: 30/09/2018

Actual: 28/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim

Regulatory

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