To collect information of 1000 patients per coumarin (acenocoumarol and phenprocoumon) to investigate the impact of height and weight on the dose needed. The database will also contain other information of the patient, like age, gender and genotypes…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The impact of height and weight on the coumarin dose required. This will be
investigated with lineair regression.
Secondary outcome
The dataset will be used as validation of the already developed acenocoumarol
and phenrocoumon dosing algorithms.
Background summary
The narrow therapeutic range of coumarins and an unpredictable response due to
large intra- and inter-patient variability makes careful patient monitoring
necessary. The principal covariates, which together account for 35-50% of the
variability, are polymorphisms in genes encoding for cytochrome P450 2C9
(CYP2C9) and vitamin K epoxide reductase complex 1 (VKORC1). It is not known
whether genotype-guided dosing during induction and maintenance therapy of
coumarins will increase the efficacy and safety of the treatment. This will be
investigated in the EU-PACT trial. The effect of height and weight on the
needed acenocoumarol and phenprocoumon is unknown. In the pre-EU-PACT study we
will investigate whether lenght and weight should be included or not in the
dosing algorithm.
Study objective
To collect information of 1000 patients per coumarin (acenocoumarol and
phenprocoumon) to investigate the impact of height and weight on the dose
needed. The database will also contain other information of the patient, like
age, gender and genotypes of CYP2C9 and VKORC1 and will be used for the
development of the dosing algorithms for the EU-PACT trial.
Study design
This is a retrospective follow-up study.
Study burden and risks
The only burden of the study for the patient is communicating their height and
weight. There are no risks associated with participation.
Sorbonnelaan 14-16, PO Box 80082
3508 TB Utrecht
Nederland
Sorbonnelaan 14-16, PO Box 80082
3508 TB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
INR target between 2.5 and 3.5
18 years or older
no participation at vitamin K study (VIKS2A)
Exclusion criteria
Pregnancy or lactation
Severe cognitive impairment
Design
Recruitment
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 |
|---|---|
| CCMO | NL28364.058.09 |