Atrial Fibrillation (AF) Clinical Trial
Official title:
EUropean Pharmacogenetics of AntiCoagulant Therapy - Phenprocoumon
Rationale:
The narrow therapeutic range and wide inter-patient variability in dose requirement make
anticoagulation response to coumarin derivatives unpredictable. As a result, patients
require frequent monitoring to avert adverse effects and maintain therapeutic efficacy.
Polymorphisms in cytochrome P450 2C9 (CYP2C9) and vitamin K epoxide reductase complex 1
(VKORC1) jointly account for about 40% of the inter-individual variability in dose
requirements. To date, several pharmacogenetic guided dosing algorithms for coumarin
derivatives, predominately for warfarin, have been developed. However, the potential benefit
of these dosing algorithms in terms of their safety and clinical utility has not been
adequately investigated in randomised settings.
Objective:
To determine whether a dosing algorithm containing genetic information increases the time
within therapeutic INR range during anticoagulation therapy with each of warfarin,
acenocoumarol and phenprocoumon compared to a dosing regimen that does not contain this
information. Secondary outcomes of the study include cost effectiveness, number of
thromboembolic and bleeding events, time to reach stable dose and number of supratherapeutic
INR peaks.
Study design:
This is a two-armed, single-blinded, randomised controlled trial. In one arm (intervention)
patients commencing anticoagulation therapy with either warfarin, acenocoumarol or
phenprocoumon will be dosed according to a drug-specific genotype-guided dosing algorithm,
which is based on genetic information, clinical data and (in the monitoring phase) previous
INR. For the other arm (control) patients will be dosed according to a non-genotype-guided
dosing regimen which does not include genetic information. The follow-up period per patient
is 3 months.
Study population:
Newly diagnosed patients of both genders and at least 18 years old who need anticoagulant
treatment with either acenocoumarol, phenprocoumon or warfarin within the low intensity INR
range will be included in the trial. Main study parameters/endpoints: The % time within
therapeutic INR range in the first 3 months of anticoagulation therapy. Nature and extent of
the burden and risks associated with participation, benefit and group relatedness: Six extra
blood samples are taken from each participant at the start of the study. Patients also have
to attend 8 scheduled visits within the 3 months study period and are asked to fill in
questionnaires. The genotype-guided dosing algorithm is anticipated to improve the accuracy
of coumarin dosing and thus improve the safety and efficacy of anticoagulation therapy.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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