Anticoagulant response to NOACS in older patients
Research type
Research Study
Full title
Investigation of the variability in anticoagulant response to novel oral anticoagulants (NOACS) in inpatients of 65 years and over.
IRAS ID
204606
Contact name
Farhad Kamali
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
The recently licensed novel oral anticoagulants(NOACS) are available as alternatives to the vitamin K antagonists, e.g. warfarin, for stroke prevention in non-valvular atrial fibrillation(NVAF) in patients over 65years, being non-inferior in efficacy, and causing fewer brain but more gastro-intestinal bleeds,with risk factors of low weight and poor renal function.Clinical trial patients had a median age below 75 with small proportions above 80 or 90 years. In view of this and short clinical experience in older people who are the main users of these drugs we aim to assess inter-individual variations in NOAC response in relation to age, renal function and body mass. In 150 medically stable inpatients in the Newcastle upon Tyne Foundation Trust 65 and over established on a NOAC within its licensed indication age, weight, height, comorbidities and medication will be recorded. 2x20ml blood samples, one directly before and one 2 hours after dosing will be collected and liver and kidney function, thrombin and diluted thrombin time (for dabigatran) and anti-factor Xa (for apixaban, rivaroxaban, edoxaban), and clotting factor activity measured. The extent of variance in drug exposure with increasing age for the study population will be determined. Each of the companies has published ranges in terms of therapeutic dose (usually around 200-400 ng/ml) and trough levels (usually 50-150 ng/ml). There is some variation in these ranges between NOACs but the information is in the Summary of Product Characteristics(SPCs) for each of the agents and these values will be used as control comparison values. Inter-individual variance and comparison to published clotting results will indicate whether pharmacokinetic and dynamic results of the 4 seminal clinical trials are transferrable to the hospitalised population. Funding is through PhD bench fees.
REC name
West of Scotland REC 4
REC reference
16/WS/0185
Date of REC Opinion
27 Sep 2016
REC opinion
Further Information Favourable Opinion