Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation (Patient convenience study (RE-SONANCE))

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11925
• EU PAS number:
  EUPAS11924
• Study ID:
  11925
• Official title and acronym:
  Non-interventional study describing patients´ perception on anticoagulant treatment and treatment convenience when treated with Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation (Patient convenience study (RE-SONANCE))
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Bulgaria

  Czechia

  Estonia

  Hungary

  Israel

  Latvia

  Poland

  Romania

  Russian Federation

  Serbia

  Slovenia
• Study description:
  The aim of this study is to describe how patients with non-valvular atrial fibrillation (NVAF)perceive anticoagulant treatment with Pradaxa (dabigatran etexilate) for stroke prevention incomparison to treatment with Vitamin K Antagonist (VKA). Two different groups (cohorts) ofpatients will be investigated:Cohort A: NVAF patients who used VKA for at least 3 months prior to study enrolment andare switched to Pradaxa.Cohort B: newly diagnosed NVAF patients who are initiated to either Pradaxa or VKAtreatment upon study enrolment.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Boehringer Ingelheim

Study timelines

Date when funding contract was signed

Planned: 27/03/2015

Actual: 27/03/2015

Study start date

Planned: 30/11/2015

Actual: 27/11/2015

Data analysis start date

Planned: 13/01/2017

Date of final study report

Planned: 31/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim RCV GmbH & Co KG

Regulatory

• Was the study required by a regulatory body?:
  No