Study identification

EU PAS number

EUPAS10457

Study ID

31059

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 (1160.247 (RE-SONANCE))

DARWIN EU® study

No

Study countries

Belgium
Denmark
Greece
Netherlands
Norway
Portugal
Sweden

Study description

RE-SONANCE is a multi-national, multi-center non-interventional study based on new data collection. 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 in comparison to treatment with Vitamin K Antagonist (VKA). Two different groups (cohorts) of patients will be investigated: - Cohort A: NVAF patients who used VKA for at least 3 months prior to study enrolment and are switched to Pradaxa.- Cohort B: newly diagnosed NVAF patients who are initiated to either Pradaxa or VKA treatment upon study enrolment.The patients will be followed up after approximately 1 month and 6 months of treatment with Pradaxa or VKA to collect the Perception of Anticoagulant Treatment Questionnaire (PACT-Q) and safety data.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 150 centres are involved in the study

Contact details

Robert Tieleman

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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