The use of NOAC for atrial fibrillation in patients after biologic valvular replacement or valvuloplasty

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/38312
• EU PAS number:
  EUPAS31606
• Study ID:
  38312
• Official title and acronym:
  The use of NOAC for atrial fibrillation in patients after biologic valvular replacement or valvuloplasty
• DARWIN EU® study:
  No
• Study countries:
  Sweden
• Study description:
  A retrospective registry-based observational study using data between 2010-2017 from the SWEDEHEART, and Swedish administrative health databases. The objective was to compare outcomes in patients with atrial fibrillation undergoing biological valve surgery, TAVI or valvuloplasty between patients treated with either apixaban or warfarin. According to protocol, after primary data analysis, a pre-planned feasibility assessment was conducted, which did not support moving forward with a comparative effectiveness study mainly due to low statistical power. A decision to not conduct any outcome analysis was taken 7th of April 2020.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Actual: 21/11/2019

Study start date

Planned: 26/08/2019

Actual: 26/08/2019

Data analysis start date

Planned: 11/12/2019

Date of interim report, if expected

Actual: 10/02/2020

Date of final study report

Planned: 17/12/2019

Actual: 05/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

B0661136_STUDY PROTOCOL_Final_191206

Regulatory

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