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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03280368

Acronym

ARCADE

Enrollment

430

Registered

2017-09-12

Start date

2014-06-30

Completion date

2020-01-31

Last updated

2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulants; Circulating, Hemorrhagic Disorder, Atrial Fibrillation, Bleeding, Blood Clot, Blood Coagulation Disorder, Blood Coagulation Tests, Drug Effect, Drug Intolerance, Drug Toxicity, Drug Use, Laboratory Problem, Medication Adherence, Thrombosis

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.

Interventions

OTHERBloodtest

OTHERQuestionnaires

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026