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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2020
Source Hospitalsenheden Vest
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Bloodtest

Questionnaires


Locations

Country Name City State
Denmark Hospital Unit West Herning Mid-Jutland

Sponsors (9)

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

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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

Outcome

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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