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

Hospitalsenheden Vest

Status: Completed

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

Treatments: Other: Bloodtest; Other: Questionnaires

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT03280368

1-16-02-191-14

Details and patient eligibility

About

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.

Enrollment: 430 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

430 participants in 4 patient groups

A healthy volunteers

Description:

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.

Treatment:

Other: Bloodtest

A patients

Description:

Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.

Treatment:

Other: Bloodtest

B

Description:

Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation.

Treatment:

Other: Bloodtest

Other: Questionnaires

C

Description:

Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.

Treatment:

Other: Bloodtest

Other: Questionnaires