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Completed

NCT Number: NCT03280368

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

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.

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Key information

Conditions

Atrial Fibrillation Anticoagulants; Circulating, Hemorrhagic Disorder Arrhythmias, Cardiac Behavior Bleeding Blood Clot Blood Coagulation Disorder Blood Coagulation Disorders Blood Coagulation Tests Cardiovascular Diseases Chemically-Induced Disorders Drug Effect Drug Intolerance Drug Toxicity Drug Use Drug-Related Side Effects and Adverse Reactions Embolism and Thrombosis Health Behavior Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Laboratory Problem Medication Adherence Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Thrombosis Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Unit West

Herning, Mid-Jutland, 7400, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bloodtest

Other

questionnaires

Other

Primary outcomes

  1. Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran

    Time frame: 2 years

    Measured by pillcount, bloodtests, the Danish National Prescription Registry and the Morisky Medication Adherence Scale

Secondary outcomes

  1. Patient treatment satisfaction

    Time frame: 2 years

    Measured by the Anticlot Treatment Scale

  2. Medication persistence

    Time frame: 2 years

    Time from start to end of dabigatran treatment

  3. Kidney function

    Time frame: 2 years

    Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula

  4. Side-effects

    Time frame: 2 years

    Bleeding, gastrointestinal side-effects

  5. Dabigatran plasma concentrations

    Time frame: 2 years

    Measured by liquid-chromatography tandem mass spectrometry (ng/mL)

  6. Weight

    Time frame: 2 years

    kilograms

  7. Height

    Time frame: 2 years

    meters

  8. Waist circumference

    Time frame: 2 years

    centimeters

  9. Prothrombin time

    Time frame: 2 years

    seconds

  10. Activated partial thromboplastin time

    Time frame: 2 years

    seconds

  11. ROTEM

    Time frame: 2 years

    Clotting time (seconds)

  12. Diluted thrombin time (calibrated for dabigatran)

    Time frame: 2 years

    ng/mL

  13. Ecarin chromogenic assay

    Time frame: 2 years

    ng/mL

Sponsors and collaborators

Lead sponsor

Hospitalsenheden Vest

Other

Collaborators

  • ANIARA
  • Boehringer Ingelheim
  • Catharina Ziekenhuis Eindhoven
  • Diagnostica Stago
  • Erasmus Medical Center
  • European Society of Cardiology
  • Siemens Corporation, Corporate Technology
  • University of Aarhus

Registry information

Official study title

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

Acronym: ARCADE

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Sep 12, 2017
Registry last updated
Feb 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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