Non-interventional study describing treatment convenience in patients treated with Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF) (RE-SONANCE)

Study identification

• EU PAS number:
  EUPAS13672
• Study ID:
  32059
• Official title and acronym:
  Non-interventional study describing treatment convenience in patients treated with Dabigatran for Stroke Prophylaxis in Atrial Fibrillation (SPAF) (RE-SONANCE)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Describe patient and physician assessed factors for patient well-being when treated with Pradaxa for stroke and embolism prevention in atrial fibrillation either compared to previous antithrombotic treatment (switcher)
• Study status:
  Finalised

Research institutions and networks

Institutions

Boehringer Ingelheim

Multiple centres: 200 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/11/2015

Actual: 01/11/2015

Study start date

Planned: 13/06/2016

Actual: 28/06/2016

Data analysis start date

Planned: 05/11/2018

Actual: 03/12/2018

Date of final study report

Planned: 30/09/2019

Actual: 20/09/2019

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)?:
  Not applicable