An observational study in Atrial Fibrillation, Medication Adherence and Blood Coagulation Tests, sponsored by Hospitalsenheden Vest. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-12.
Sponsored by Hospitalsenheden Vest · Observational
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 430 is above the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Hospitalsenheden Vest is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with atrial fibrillation with an indication for initiation of dabigatran etexilate
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre-clinical study. Healthy volunteers. Plasma pooled and spiked with dabigatran. Measurement of plasma concentration of dabigatran with liquid chromatography tandem mass-spectrometry and the anticoagulant effect of dabigatran using coagulation assays.
Other: Bloodtest
Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
Other: Bloodtest
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation.
Other: Bloodtest · Other: Questionnaires
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.
Other: Bloodtest · Other: Questionnaires
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
Plan to share: No
The record gives a start of Jun 2014, a primary completion of Nov 2019 and a completion of Jan 2020. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Hospitalsenheden Vest