Voluntary PASS non interventional study: Retrospective Observational Study of VKA and Novel Oral Anticoagulants in Patients with Non-valvular Atrial Fibrillation:

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/17533
• EU PAS number:
  EUPAS11897
• Study ID:
  17533
• Official title and acronym:
  Voluntary PASS non interventional study: Retrospective Observational Study of VKA and Novel Oral Anticoagulants in Patients with Non-valvular Atrial Fibrillation:
• DARWIN EU® study:
  No
• Study countries:
  Japan
• Study description:
  The four novel oral anticoagulants (NOACs) were available in Japan for reduction of the risk of stroke and systemic embolism (SE) among patients with NVAF: edoxaban in September 2014, apixaban in Februray, 2013, rivaroxaban in April 2012, and dabigatran etexilate in March 2011.Despite the evidence on efficacy and safety of these NOACs from RCTs, little is known about how they perform in real-world clinical practice settings. This study will assess the following- baseline demographics and clinical characteristics of NVAF patients prescribed apixaban, rivaroxaban, dabigatran or warfarin, treatment patterns of anitcoagulanttherapy, rates of occurrence of a bleeding event, and healthcare resource use. Edoxaban is excluded from this study because of limited sample size.
• Study status:
  Planned

Research institutions and networks

Institutions

Crecon

Study timelines

Date when funding contract was signed

Planned: 01/10/2015

Study start date

Planned: 23/12/2015

Date of final study report

Planned: 30/06/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer-Japan

Study protocol

Initial protocol

20151210_Pfizer-OAC_MDV_data_Japan_Protocol For REVIEW (2)

Regulatory

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