ALPHA-PE
Research type
Research Study
Full title
Apixaban Length-Of-Stay Pulmonary Embolism study - Hospital Admissions (ALPHA-PE)
IRAS ID
223148
Contact name
Raza Alikhan
Contact email
Sponsor organisation
Cardiff and Vale UHB
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
The length of hospital stay following a diagnosis of acute pulmonary embolism (PE)
In the UK, 1–2 per 1,000 of the adult population suffer an episode of venous thromboembolism per year, comprised of deep vein thrombosis and PE.
Treatment for PE comprises anticoagulation; however, standard of care (including heparin and warfarin) is associated with administration, dosing and tolerability issues, often requiring extended stays in hospital. Novel, direct-acting oral anticoagulants (DOACs), such as apixaban, may alleviate some of this burden due to their predictable pharmacokinetic profile and direct mode of action.
This study is designed to determine whether the average length of stay in hospital has decreased since the introduction of apixaban in 2015. The demographics of patients treated with anticoagulants under consideration will also be compared.
The study will take place in six UK Hospitals which prescribe apixaban for the treatment of acute PE. It will involve a retrospective chart review of adult patients admitted with an acute PE and initiated on anticoagulation for two time periods: 1st January 2013 – 30th June 2013 (prior to NICE approval of apixaban) and 1st January 2017 – 30th June 2017 (following NICE approval). The data collection will not involve direct patient contact.
The study is sponsored by Bristol-Myers Squibb Pharmaceuticals Ltd.
REC name
HSC REC A
REC reference
17/NI/0128
Date of REC Opinion
6 Jul 2017
REC opinion
Further Information Favourable Opinion