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

Completed

• Conditions: Blood Coagulation Tests; Drug Use; Drug Intolerance; Drug Toxicity; Blood Coagulation Disorder; Thrombosis; Blood Clot; Atrial Fibrillation; Bleeding; Medication Adherence
• Interventions: Other: Bloodtest; Other: Questionnaires

• Registration Number: NCT03280368
• Lead Sponsor: Hospitalsenheden Vest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2016-10-26
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Primary Completion: 2019-11
• Study Completion: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	Bloodtest	Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation.
C	Bloodtest	Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.
A patients	Bloodtest	Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
B	Questionnaires	Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation.
A healthy volunteers	Bloodtest	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.
C	Questionnaires	Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Unit West; 🇩🇰 Herning, Mid-Jutland, Denmark