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Direct oral anticoagulants (DOAC) dosing patients with non-valvular atrial fibrillation (NVAF): a retrospective cohort study using the Clinical Practice Research Datalink (CPRD) Gold database

Safe People

Organisation name

LA-SER Europe Ltd

Organisation sector

Commercial

Applicant name(s)

Artak Khachatryan - Chief Investigator - LA-SER Europe Ltd ( Certara )Yousef Zawaneh - Corresponding Applicant - LA-SER Europe Ltd ( Certara )Farhan Mughal - Collaborator - Daiichi Sankyogaelle gusto - Collaborator - LA-SER Europe Ltd ( Certara )Georgios Spentzouris - Collaborator - Daiichi-Sankyo EuropeJolanta Wrotniak-Vucic - Collaborator - LA-SER Europe Ltd ( Certara )Umesh Doobaree - Collaborator - LA-SER Europe Ltd ( Certara )

Safe Projects

Project ID

CPRD890

Lay summary

Non-Valvular Atrial fibrillation (NVAF) is a quivering or irregular heartbeat that can lead to blood clotting, which can lead to stroke, heart attacks (blocked arteries) or other thromboembolism (blocked blood vessels) in other parts of the body. It is typically treated using anticoagulants (blood thinners), which prevent the formation of blood clots. Direct Oral Anti Coagulants (DOACs) are recommended in the UK for the prevention of clots. In every day clinical practice, it is essential that patients receive the correct dose of DOAC as under-dosing can lead to clot formation and overdosing can lead to bleeding. The dose is adjusted depending on whether a patient has certain conditions such kidney failure in which case the dose will be lowered. The aim of this research is to understand how DOACs (apixaban, rivaroxaban, dabigatran and edoxaban) are used in the UK and whether the doses they received were under or over the recommended dose. It will also describe the patients’ characteristics and other factors that may affect how they benefit from their DOAC treatment. With this information, this study will investigate the occurrence of strokes, major bleeding, embolism and mortality according the whether they are doses correctly or have received an under- or overdosing of DOACs.

Technical summary

NVAF is an atrial tachyarrhythmia characterized by predominantly uncoordinated atrial activation with consequent deterioration of atrial mechanical function. European Society of Cardiology (ESC) Guidelines (2020) have underlined the importance of direct oral anticoagulants (DOAC) for stroke prevention compared to standard anticoagulants in NVAF. One of the major problems with the management of DOACs is that in routine practice, doses are often inconsistent with drug labelling which may be associated with worse outcomes. The aim of this study is to investigate DOAC (apixaban, rivaroxaban, dabigatran and edoxaban) dosing patterns and associated outcomes in patients treated in routine clinical practice in the UK.

Latest approval date

18/01/2021

Safe Data

Dataset(s) name

HES Admitted Patient Care

ONS Death Registration Data

Safe Setting

Access type

Release