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

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.

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

Interventions

OTHER

Bloodtest

OTHER

Questionnaires

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Siemens Corporation, Corporate Technology

  collaborator INDUSTRY

• Diagnostica Stago

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• European Society of Cardiology

  collaborator NETWORK

• ANIARA

  collaborator UNKNOWN

• University of Aarhus

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Hospitalsenheden Vest

  lead OTHER

Principal Investigators

• Willemijn Comuth, MD · Hospitalsenheden Vest

• Steen Husted, MD, PhD · Hospitalsenheden Vest

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-30

Primary Completion

2019-11-30

Completion

2020-01-31

Countries

• Denmark

Study Locations