NCT03280368

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

Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular Atrial Fibrillation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 430 (actual)
• Sponsor: Hospitalsenheden Vest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	Bloodtest
OTHER	Questionnaires

Timeline

• Start date: 2014-06-01
• Primary completion: 2019-11-01
• Completion: 2020-01-01
• First posted: 2017-09-12
• Last updated: 2020-02-12

Locations

1 site across 1 country: Denmark