Risk of stroke and other cardiovascular events among warfarin-treated atrial fibrillation patients – a nationwide cohort study in Finland (FinWAF)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18730
• EU PAS number:
  EUPAS4700
• Study ID:
  18730
• Official title and acronym:
  Risk of stroke and other cardiovascular events among warfarin-treated atrial fibrillation patients – a nationwide cohort study in Finland (FinWAF)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  This is a retrospective database linkage study using patient information system data from hospital laboratory databases with linkage to nationwide registers. The study population consists of all atrial fibrillation patients using warfarin with INR measurements in selected hospital district areas in Finland between 01-Jan-2007 and 31-Dec-2009. The main objective is to investigate and compare risk of stroke, systemic thromboembolism, myocardial infarction, bleeding events and mortality among atrial fibrillation patients in relation to International Normalized Ratio levels.
• Study status:
  Finalised

Research institution and networks

Institutions

EPID Research Oy

Study timelines

Date when funding contract was signed

Actual: 29/10/2012

Study start date

Planned: 05/05/2014

Actual: 16/05/2014

Date of final study report

Planned: 31/12/2015

Actual: 31/12/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol-Myers Squibb

Study protocol

Initial protocol

ER12-9441 cv185266-prot 20130514

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable