RELATIVE EFFECTIVENESS OF DRONEDARONE VS. OTHER TREATMENTS OF ATRIAL FIBRILLATION (EFFECT-AF)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18345
• EU PAS number:
  EUPAS3351
• Study ID:
  18345
• Official title and acronym:
  RELATIVE EFFECTIVENESS OF DRONEDARONE VS. OTHER TREATMENTS OF ATRIAL FIBRILLATION (EFFECT-AF)
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Italy

  Spain

  United States
• Study description:
  This is an international observational multicentre study to be conducted in Germany, Spain, Italy and USA. The main objective of the study is to evaluate the relative effectiveness of dronedarone in real world clinical practice versus other anti-arrhythmic agents of interest.The design of the study is a historic-prospective cohort with dynamic exposure and stratified competitive recruitment with balanced comparison groups of dronedarone versus alternative antiarrhythmic drugs of interest.
• Study status:
  Finalised

Research institutions and networks

Institutions

Real World Studies, LA-SER Research

France

United Kingdom

Multiple centres: 170 centers are involved in the study

Study timelines

Date when funding contract was signed

Actual: 11/10/2012

Study start date

Planned: 01/04/2013

Actual: 18/03/2013

Date of interim report, if expected

Actual: 12/02/2016

Date of final study report

Planned: 28/02/2017

Actual: 30/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-Aventis R&D

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable