Pattern of use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation patients in UK general practices

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/34784
• EU PAS number:
  EUPAS18521
• Study ID:
  34784
• Official title and acronym:
  Pattern of use of Direct Oral Anticoagulants in Non-valvular Atrial Fibrillation patients in UK general practices
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Many people who suffer from irregular heartbeats (atrial fibrillation) which might cause stroke, need to take blood thinners to prevent it. It is important to prescribe the correct dose of blood thinners to the right patients to ensure the treatment works however avoiding complications. In the recent years, new blood thinners have been available, they require less laboratory tests and fewer visits to a doctor compared to older therapies. This study will look at how the general practitioners in the UK prescribe blood thinners according to the instructions given by the product manufacturer. We will use primary care data that is routinely collected by the general practitioners about their patients but without any possibility to identify individual patients. The results will help us to understand the magnitude of deviation from instructions in order to ensure that the patients benefit from the treatment.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fundación Centro Español de Investigación Farmacoepidemiológica (CEIFE)

Spain

Study timelines

Date when funding contract was signed

Planned: 30/01/2017

Actual: 30/01/2017

Study start date

Planned: 15/05/2017

Actual: 15/05/2017

Data analysis start date

Planned: 15/05/2017

Actual: 15/05/2017

Date of final study report

Planned: 31/01/2019

Actual: 21/05/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

THIN-CPRD Protocol_NOAC PASS_02032017_PRC_Clean

Updated protocol

THIN-CPRD Protocol_NOAC PASS_02032017_PRC_Final

Regulatory

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