The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
TDM
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is body weight and the primary endpoint is the DOAC
trough concentration.
Secondary outcome
The secondary endpoints will be
- The trough anti-FXa activity (apixaban, rivaroxaban and edoxaban)
- The trough anti-FIIa activity (dabigatran)
Background summary
This study will reveal more information about DOAC drug concentrations related
to body weight. Edoxaban and apixaban dose recommendations are made for low
body weight as described in the SPC. The SPCs of dabigatran and rivaroxaban
describe to use the medicines with caution when the patient*s body weight is
less than 50 kg for rivaroxaban and less than 60 kg for dabigatran, especially
when combined with other oral anticoagulants. Using with caution is hard to
define in daily practice, so a clear advice is required. This also applies for
people with a high bodyweight where almost all SPCs, except edoxaban, claim
that DOAC exposure is lower for this patient group. Any new information about
the relation body weight and DOAC drug concentrations can provide new insights
on how to treat these patients with under* and overweight in a safe and
effective way.
Study objective
The aim of this study is to investigate the effect of body weight on the trough
concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
Study design
This exploratory cohort study will investigate the effect of body weight on the
trough concentrations of DOACs in patients from the Haga Teaching Hospital.
Study burden and risks
The risks the patients are exposed to are complications from blood sampling.
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Els Borst-Eilersplein 275
Den Haag 2545 AA
NL
Listed location countries
Age
Inclusion criteria
- Male or female * 18 years
- Treated with a DOAC (rivaroxaban, dabigatran, apixaban, edoxaban) in a therapeutic or prophylactic dosage for at least five days
- eGFR > 50 ml/min
- Is not mentally disabled
- Good understanding of the Dutch language
- Written informed consent
Exclusion criteria
- Collected blood sample is not a trough concentration
- Relevant co-medication (table 1 of study-protocol)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-003569-91-NL |
| CCMO | NL62896.098.17 |