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

NCT03280368 | Completed

• 1 other identifier: 1-16-02-191-14
• Study Type: observational
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (13)

• Patient treatment satisfaction

  2 years

• Medication persistence

  2 years

• Kidney function

  2 years

• Side-effects

  2 years

• Dabigatran plasma concentrations

  2 years

Study Arms (4)

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

Interventions

Bloodtest OTHER

A healthy volunteers; A patients; B; C

Questionnaires OTHER

B; C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation with an indication for initiation of dabigatran etexilate

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Unit West

Herning, Mid-Jutland, 7400, Denmark

Location

Related Publications (3)

• 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.

  PMID: 30608563 RESULT

• 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.

  PMID: 31249952 RESULT

• 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.

  PMID: 29475179 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Medication Adherence; Hemorrhagic Disorders; Drug-Related Side Effects and Adverse Reactions; Thrombosis; Blood Coagulation Disorders; Hemorrhage

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Hematologic Diseases; Hemic and Lymphatic Diseases; Chemically-Induced Disorders; Embolism and Thrombosis; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Willemijn Comuth, MD

  Hospitalsenheden Vest

  PRINCIPAL INVESTIGATOR

• Steen Husted, MD, PhD

  Hospitalsenheden Vest

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist, PhD-fellow

Study Record Dates

• First Submitted: October 26, 2016
• First Posted: September 12, 2017
• Study Start: June 1, 2014
• Primary Completion: November 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)