Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation (ARCADE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03280368|
Recruitment Status : Active, not recruiting
First Posted : September 12, 2017
Last Update Posted : August 7, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||430 participants|
|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|
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.
Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate.
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion.
Inclusion before initiation of anticoagulation.
Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation.
- 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
- Patient treatment satisfaction [ Time Frame: 2 years ]Measured by the Anticlot Treatment Scale
- Medication persistence [ Time Frame: 2 years ]Time from start to end of dabigatran treatment
- Kidney function [ Time Frame: 2 years ]Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula
- Side-effects [ Time Frame: 2 years ]Bleeding, gastrointestinal side-effects
- Dabigatran plasma concentrations [ Time Frame: 2 years ]Measured by liquid-chromatography tandem mass spectrometry (ng/mL)
- Weight [ Time Frame: 2 years ]kilograms
- Height [ Time Frame: 2 years ]meters
- Waist circumference [ Time Frame: 2 years ]centimeters
- Prothrombin time [ Time Frame: 2 years ]seconds
- Activated partial thromboplastin time [ Time Frame: 2 years ]seconds
- ROTEM [ Time Frame: 2 years ]Clotting time (seconds)
- Diluted thrombin time (calibrated for dabigatran) [ Time Frame: 2 years ]ng/mL
- Ecarin chromogenic assay [ Time Frame: 2 years ]ng/mL
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
|Hospital Unit West|
|Herning, Mid-Jutland, Denmark, 7400|
|Principal Investigator:||Willemijn Comuth, MD||Hospitalsenheden Vest|
|Study Chair:||Steen Husted, MD, PhD||Hospitalsenheden Vest|