In patients with non-valvular atrial fibrillation treated with dabigatran etexilate, the level of adherence will be measured using a questionnaire, the Danish National Prescription Registry and pillcount and will be related to plasma levels of dabigatran measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) and coagulation assays. The aim of the study is to measure the level of adherence and evaluate the usefulness of different coagulation assays to measure adherence in these patients. Furthermore, the aim is to determine the correlation between the anticoagulant effect of dabigatran using different coagulation assays and plasma levels of dabigatran. Most studies so far have been performed in vitro with plasma samples spiked with dabigatran. In this study the present knowledge from results of coagulation assays in dabigatran spiked plasma samples will be compared to the results of coagulation assays using blood samples from real-life patients.
Study Type
OBSERVATIONAL
Enrollment
430
Hospital Unit West
Herning, Mid-Jutland, Denmark
Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran
Measured by pillcount, bloodtests, the Danish National Prescription Registry and the Morisky Medication Adherence Scale
Time frame: 2 years
Patient treatment satisfaction
Measured by the Anticlot Treatment Scale
Time frame: 2 years
Medication persistence
Time from start to end of dabigatran treatment
Time frame: 2 years
Kidney function
Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula
Time frame: 2 years
Side-effects
Bleeding, gastrointestinal side-effects
Time frame: 2 years
Dabigatran plasma concentrations
Measured by liquid-chromatography tandem mass spectrometry (ng/mL)
Time frame: 2 years
Weight
kilograms
Time frame: 2 years
Height
meters
Time frame: 2 years
Waist circumference
centimeters
Time frame: 2 years
Prothrombin time
seconds
Time frame: 2 years
Activated partial thromboplastin time
seconds
Time frame: 2 years
ROTEM
Clotting time (seconds)
Time frame: 2 years
Diluted thrombin time (calibrated for dabigatran)
ng/mL
Time frame: 2 years
Ecarin chromogenic assay
ng/mL
Time frame: 2 years
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