Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation

Overview

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.

Full Title of Study: “Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular Atrial Fibrillation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2019

Interventions

  • Other: Bloodtest
  • Other: Questionnaires

Arms, Groups and Cohorts

  • 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.
  • A patients
    • Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
  • B
    • Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation.
  • C
    • Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.

Clinical Trial Outcome Measures

Primary Measures

  • Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran
    • Time Frame: 2 years
    • Measured by pillcount, bloodtests, the Danish National Prescription Registry and the Morisky Medication Adherence Scale

Secondary Measures

  • Patient treatment satisfaction
    • Time Frame: 2 years
    • Measured by the Anticlot Treatment Scale
  • Medication persistence
    • Time Frame: 2 years
    • Time from start to end of dabigatran treatment
  • Kidney function
    • Time Frame: 2 years
    • Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula
  • Side-effects
    • Time Frame: 2 years
    • Bleeding, gastrointestinal side-effects
  • Dabigatran plasma concentrations
    • Time Frame: 2 years
    • Measured by liquid-chromatography tandem mass spectrometry (ng/mL)
  • Weight
    • Time Frame: 2 years
    • kilograms
  • Height
    • Time Frame: 2 years
    • meters
  • Waist circumference
    • Time Frame: 2 years
    • centimeters
  • Prothrombin time
    • Time Frame: 2 years
    • seconds
  • Activated partial thromboplastin time
    • Time Frame: 2 years
    • seconds
  • ROTEM
    • Time Frame: 2 years
    • Clotting time (seconds)
  • Diluted thrombin time (calibrated for dabigatran)
    • Time Frame: 2 years
    • ng/mL
  • Ecarin chromogenic assay
    • Time Frame: 2 years
    • ng/mL

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hospitalsenheden Vest
  • Collaborator
    • Catharina Ziekenhuis Eindhoven
  • Provider of Information About this Clinical Study
    • Principal Investigator: Willemijn Comuth, Cardiologist, PhD-fellow – Hospitalsenheden Vest
  • Overall Official(s)
    • Willemijn Comuth, MD, Principal Investigator, Hospitalsenheden Vest
    • Steen Husted, MD, PhD, Study Chair, Hospitalsenheden Vest

Citations Reporting on Results

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. Erratum In: Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5(2):99.

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.

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