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Atrial FibrillationARCADENCT03280368

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

An observational study of Atrial Fibrillation and Medication Adherence, run by Hospitalsenheden Vest at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Bloodtest and Questionnaires
How many people
430 participants
Where
1 siteDenmark
Study dates
Jun 2014to Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients with atrial fibrillation with an indication for initiation of dabigatran etexilate

Who may be able to join

  • Age 18 years or older
  • Non-valvular atrial fibrillation
  • Indication for dabigatran etexilate

Who cannot join

  • Use of anticoagulant medication within the last month
  • Contra-indication to dabigatran etexilate
  • Unable or not wishing to give informed consent

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hospital Unit West

    Herning, Mid-Jutland, 7400

Other trials in Denmark

About this study

Official title: Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular 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.

Being tested
Bloodtest, Questionnaires
Medical subject headings
Atrial Fibrillation, Medication Adherence, Hemorrhagic Disorders, Drug-Related Side Effects and Adverse Reactions, Thrombosis, Blood Coagulation Disorders, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BloodtestOther

  • QuestionnairesOther

Study groups in NCT03280368
Study groupRoleWhat they receive
A healthy volunteersPre-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.
Receives: Other: Bloodtest
A patientsPre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
Receives: Other: Bloodtest
BPatients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation.
Receives: Other: Bloodtest; Other: Questionnaires
CPatients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.
Receives: Other: Bloodtest; Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 2 years

Secondary outcomes (13)

  1. Patient treatment satisfaction

    Measured by the Anticlot Treatment Scale

    Measured: 2 years

  2. Medication persistence

    Time from start to end of dabigatran treatment

    Measured: 2 years

  3. Kidney function

    Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula

    Measured: 2 years

  4. Side-effects

    Bleeding, gastrointestinal side-effects

    Measured: 2 years

  5. Dabigatran plasma concentrations

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

    Measured: 2 years

  6. Weight

    kilograms

    Measured: 2 years

  7. Height

    meters

    Measured: 2 years

  8. Waist circumference

    centimeters

    Measured: 2 years

  9. Prothrombin time

    seconds

    Measured: 2 years

  10. Activated partial thromboplastin time

    seconds

    Measured: 2 years

  11. ROTEM

    Clotting time (seconds)

    Measured: 2 years

  12. Diluted thrombin time (calibrated for dabigatran)

    ng/mL

    Measured: 2 years

  13. Ecarin chromogenic assay

    ng/mL

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2017
  2. Study startJun 2014
  3. Primary completionNov 2019
  4. Study completionJan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03280368
Sponsor's protocol ID
1-16-02-191-14
Acronym
ARCADE
Status last verified
Feb 2020
First submitted
26 Oct 2016
Last updated
12 Feb 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Comuth WJ, de Maat MPM, van de Kerkhof D, Malczynski J, Husted S, Kristensen SD, Munster AB. Adherence to dabigatran etexilate in atrial fibrillation patients intended to undergo electrical cardioversion. Eur Heart J Cardiovasc Pharmacother. 2019 Apr 1;5(2):91-99. doi: 10.1093/ehjcvp/pvy047.

    PubMed 30608563

  • Comuth WJ, Lauridsen HH, Kristensen SD, Munster 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 Jul.

    PubMed 31249952

  • Comuth WJ, Henriksen LO, van de Kerkhof D, Husted SE, Kristensen SD, de Maat MPM, Munster 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.thromres.2018.02.141. Epub 2018 Feb 17.

    PubMed 29475179

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation and Medication Adherence, run by Hospitalsenheden Vest at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication adherence Stability after storage at -80 degrees C; correlation between plasma concentration and the anticoagulant effect of dabigatran (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03280368, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.

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