Atrial Fibrillation Clinical Trial
— ARCADEOfficial title:
Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular Atrial Fibrillation
NCT number | NCT03280368 |
Other study ID # | 1-16-02-191-14 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 2014 |
Est. completion date | January 2020 |
Verified date | February 2020 |
Source | Hospitalsenheden Vest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 430 |
Est. completion date | January 2020 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age 18 years or older - Non-valvular atrial fibrillation - Indication for dabigatran etexilate Exclusion Criteria: - Use of anticoagulant medication within the last month - Contra-indication to dabigatran etexilate - Unable or not wishing to give informed consent |
Country | Name | City | State |
---|---|---|---|
Denmark | Hospital Unit West | Herning | Mid-Jutland |
Lead Sponsor | Collaborator |
---|---|
Hospitalsenheden Vest | ANIARA, Boehringer Ingelheim, Catharina Ziekenhuis Eindhoven, Diagnostica Stago, Erasmus Medical Center, European Society of Cardiology, Siemens Corporation, Corporate Technology, University of Aarhus |
Denmark,
Comuth WJ, de Maat MPM, van de Kerkhof D, Malczynski J, Husted S, Kristensen SD, Münster AB. Adherence to dabigatran etexilate in atrial fibrillation patients intended to undergo electrical cardioversion. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5( — View Citation
Comuth WJ, Henriksen LØ, van de Kerkhof D, Husted SE, Kristensen SD, de Maat MPM, Münster AB. Comprehensive characteristics of the anticoagulant activity of dabigatran in relation to its plasma concentration. Thromb Res. 2018 Apr;164:32-39. doi: 10.1016/j — View Citation
Comuth WJ, Lauridsen HH, Kristensen SD, Münster AB. Translation, Cultural Adaptation, and Psychometric Properties of the Danish Version of the Anti-Clot Treatment Scale. TH Open. 2018 Sep 13;2(3):e280-e290. doi: 10.1055/s-0038-1670631. eCollection 2018 Ju — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 2 years | |
Secondary | Patient treatment satisfaction | Measured by the Anticlot Treatment Scale | 2 years | |
Secondary | Medication persistence | Time from start to end of dabigatran treatment | 2 years | |
Secondary | Kidney function | Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula | 2 years | |
Secondary | Side-effects | Bleeding, gastrointestinal side-effects | 2 years | |
Secondary | Dabigatran plasma concentrations | Measured by liquid-chromatography tandem mass spectrometry (ng/mL) | 2 years | |
Secondary | Weight | kilograms | 2 years | |
Secondary | Height | meters | 2 years | |
Secondary | Waist circumference | centimeters | 2 years | |
Secondary | Prothrombin time | seconds | 2 years | |
Secondary | Activated partial thromboplastin time | seconds | 2 years | |
Secondary | ROTEM | Clotting time (seconds) | 2 years | |
Secondary | Diluted thrombin time (calibrated for dabigatran) | ng/mL | 2 years | |
Secondary | Ecarin chromogenic assay | ng/mL | 2 years |
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