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Trial record 94 of 333 for:    DABIGATRAN

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

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ClinicalTrials.gov Identifier: NCT03280368
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Catharina Ziekenhuis Eindhoven
Siemens Corporation, Corporate Technology
Diagnostica Stago
Boehringer Ingelheim
European Society of Cardiology
ANIARA
University of Aarhus
Erasmus Medical Center
Information provided by (Responsible Party):
Willemijn Comuth, Hospitalsenheden Vest

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.


Condition or disease Intervention/treatment
Atrial Fibrillation Medication Adherence Blood Coagulation Tests Anticoagulants; Circulating, Hemorrhagic Disorder Drug Effect Drug Use Drug Toxicity Drug Intolerance Blood Clot Blood Coagulation Disorder Laboratory Problem Bleeding Thrombosis Other: Bloodtest Other: Questionnaires

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Study Type : Observational
Actual Enrollment : 430 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adherence and the Role of Coagulation Assays in Patients Treated With Dabigatran Etexilate for Non-valvular Atrial Fibrillation
Study Start Date : June 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020


Group/Cohort Intervention/treatment
A healthy volunteers
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.
Other: Bloodtest
A patients
Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
Other: Bloodtest
B

Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion.

Inclusion before initiation of anticoagulation.

Other: Bloodtest
Other: Questionnaires
C
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.
Other: Bloodtest
Other: Questionnaires



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with atrial fibrillation with an indication for initiation of dabigatran etexilate
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Non-valvular atrial fibrillation
  • Indikation 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280368


Locations
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Denmark
Hospital Unit West
Herning, Mid-Jutland, Denmark, 7400
Sponsors and Collaborators
Hospitalsenheden Vest
Catharina Ziekenhuis Eindhoven
Siemens Corporation, Corporate Technology
Diagnostica Stago
Boehringer Ingelheim
European Society of Cardiology
ANIARA
University of Aarhus
Erasmus Medical Center
Investigators
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Principal Investigator: Willemijn Comuth, MD Hospitalsenheden Vest
Study Chair: Steen Husted, MD, PhD Hospitalsenheden Vest

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Responsible Party: Willemijn Comuth, Cardiologist, PhD-fellow, Hospitalsenheden Vest
ClinicalTrials.gov Identifier: NCT03280368     History of Changes
Other Study ID Numbers: 1-16-02-191-14
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dabigatran
Atrial Fibrillation
Thrombosis
Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Disease
Drug-Related Side Effects and Adverse Reactions
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases
Hematologic Diseases
Chemically-Induced Disorders
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants