Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
NCT ID: NCT03280368
Last Updated: 2020-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
430 participants
OBSERVATIONAL
2014-06-30
2020-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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A healthy volunteers
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.
Bloodtest
A patients
Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
Bloodtest
B
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion.
Inclusion before initiation of anticoagulation.
Bloodtest
Questionnaires
C
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.
Bloodtest
Questionnaires
Interventions
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Bloodtest
Questionnaires
Eligibility Criteria
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Inclusion Criteria
* Non-valvular atrial fibrillation
* Indication for dabigatran etexilate
Exclusion Criteria
* Contra-indication to dabigatran etexilate
* Unable or not wishing to give informed consent
18 Years
ALL
Yes
Sponsors
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Catharina Ziekenhuis Eindhoven
OTHER
Siemens Corporation, Corporate Technology
INDUSTRY
Diagnostica Stago
INDUSTRY
Boehringer Ingelheim
INDUSTRY
European Society of Cardiology
NETWORK
ANIARA
UNKNOWN
University of Aarhus
OTHER
Erasmus Medical Center
OTHER
Hospitalsenheden Vest
OTHER
Responsible Party
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Willemijn Comuth
Cardiologist, PhD-fellow
Principal Investigators
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Willemijn Comuth, MD
Role: PRINCIPAL_INVESTIGATOR
Hospitalsenheden Vest
Steen Husted, MD, PhD
Role: STUDY_CHAIR
Hospitalsenheden Vest
Locations
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Hospital Unit West
Herning, Mid-Jutland, Denmark
Countries
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References
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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.
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.
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.
Other Identifiers
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1-16-02-191-14
Identifier Type: -
Identifier Source: org_study_id
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