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

Atrial Fibrillation Clinical Trial

— ARCADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280368
• Other study ID #: 1-16-02-191-14
• Status: Completed
• Start date: June 2014
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: Hospitalsenheden Vest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: January 2020
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulants; Circulating, Hemorrhagic Disorder
• Atrial Fibrillation
• Bleeding
• Blood Clot
• Blood Coagulation Disorder
• Blood Coagulation Disorders
• Blood Coagulation Tests
• Disease
• Drug Effect
• Drug Intolerance
• Drug Toxicity
• Drug Use
• Drug-Related Side Effects and Adverse Reactions
• Hemorrhagic Disorders
• Hemostatic Disorders
• Laboratory Problem
• Medication Adherence
• Thrombosis

Intervention

Other:
• Bloodtest

• Questionnaires

Locations

Country	Name	City	State
Denmark	Hospital Unit West	Herning	Mid-Jutland

Sponsors (9)

Lead Sponsor	Collaborator
Hospitalsenheden Vest	ANIARA, Boehringer Ingelheim, Catharina Ziekenhuis Eindhoven, Diagnostica Stago, Erasmus Medical Center, European Society of Cardiology, Siemens Corporation, Corporate Technology, University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

Comuth WJ, de Maat MPM, van de Kerkhof D, Malczynski J, Husted S, Kristensen SD, Münster AB. Adherence to dabigatran etexilate in atrial fibrillation patients intended to undergo electrical cardioversion. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5( — View Citation

Comuth WJ, Henriksen LØ, van de Kerkhof D, Husted SE, Kristensen SD, de Maat MPM, Münster 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 — View Citation

Comuth WJ, Lauridsen HH, Kristensen SD, Münster 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 Ju — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran	Measured by pillcount, bloodtests, the Danish National Prescription Registry and the Morisky Medication Adherence Scale	2 years
Secondary	Patient treatment satisfaction	Measured by the Anticlot Treatment Scale	2 years
Secondary	Medication persistence	Time from start to end of dabigatran treatment	2 years
Secondary	Kidney function	Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula	2 years
Secondary	Side-effects	Bleeding, gastrointestinal side-effects	2 years
Secondary	Dabigatran plasma concentrations	Measured by liquid-chromatography tandem mass spectrometry (ng/mL)	2 years
Secondary	Weight	kilograms	2 years
Secondary	Height	meters	2 years
Secondary	Waist circumference	centimeters	2 years
Secondary	Prothrombin time	seconds	2 years
Secondary	Activated partial thromboplastin time	seconds	2 years
Secondary	ROTEM	Clotting time (seconds)	2 years
Secondary	Diluted thrombin time (calibrated for dabigatran)	ng/mL	2 years
Secondary	Ecarin chromogenic assay	ng/mL	2 years