Clinical trial NCT03280368: Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
Official title: Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Medication Adherence
Blood Coagulation Tests
Anticoagulants; Circulating, Hemorrhagic Disorder
Drug Effect
Drug Use
Drug Toxicity
Drug Intolerance
Blood Clot
Blood Coagulation Disorder
Laboratory Problem
Bleeding
Thrombosis
Lead sponsor: Hospitalsenheden Vest
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
name: Siemens Corporation, Corporate Technology
name: Diagnostica Stago
name: Boehringer Ingelheim
name: European Society of Cardiology
name: ANIARA
name: University of Aarhus
name: Erasmus Medical Center
First posted: 2017-09-12
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation with an indication for initiation of dabigatran etexilate

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran
timeFrame: 2 years
Secondary outcomes:
measure: Patient treatment satisfaction
timeFrame: 2 years
measure: Medication persistence
timeFrame: 2 years
measure: Kidney function
timeFrame: 2 years
measure: Side-effects
timeFrame: 2 years
measure: Dabigatran plasma concentrations
timeFrame: 2 years
measure: Weight
timeFrame: 2 years
measure: Height
timeFrame: 2 years
measure: Waist circumference
timeFrame: 2 years
measure: Prothrombin time
timeFrame: 2 years
measure: Activated partial thromboplastin time
timeFrame: 2 years
measure: ROTEM
timeFrame: 2 years
measure: Diluted thrombin time (calibrated for dabigatran)
timeFrame: 2 years
measure: Ecarin chromogenic assay
timeFrame: 2 years
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Hospital Unit West
state: Mid-Jutland
Study officials:
affiliation: Hospitalsenheden Vest
name: Willemijn Comuth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospitalsenheden Vest
name: Steen Husted, MD, PhD
role: STUDY_CHAIR
References:
citation: Comuth WJ, de Maat MPM, van de Kerkhof D, Malczynski J, Husted S, Kristensen SD, Munster AB. Adherence to dabigatran etexilate in atrial fibrillation patients intended to undergo electrical cardioversion. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5(2):91-99. doi: 10.1093/ehjcvp/pvy047.
citation: Comuth WJ, Lauridsen HH, Kristensen SD, Munster 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 Jul.
citation: Comuth WJ, Henriksen LO, van de Kerkhof D, Husted SE, Kristensen SD, de Maat MPM, Munster 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.thromres.2018.02.141. Epub 2018 Feb 17.