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| Name | Class |
|---|---|
| Catharina Ziekenhuis Eindhoven | OTHER |
| Siemens Corporation, Corporate Technology | INDUSTRY |
| Diagnostica Stago | INDUSTRY |
| Boehringer Ingelheim |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| A patients | Pre-clinical study. Patients with atrial fibrillation treated with dabigatran etexilate. |
| |
| B | Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation and intended for electrocardioversion. Inclusion before initiation of anticoagulation. |
| |
| C | Patients with an indication for treatment with dabigatran etexilate for atrial fibrillation. Inclusion before initiation of anticoagulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloodtest | Other |
| ||
| Questionnaires |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient treatment satisfaction | Measured by the Anticlot Treatment Scale | 2 years |
| Medication persistence | Time from start to end of dabigatran treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with atrial fibrillation with an indication for initiation of dabigatran etexilate
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| Name | Affiliation | Role |
|---|---|---|
| Willemijn Comuth, MD | Hospitalsenheden Vest | Principal Investigator |
| Steen Husted, MD, PhD | Hospitalsenheden Vest | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Unit West | Herning | Mid-Jutland | 7400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30608563 | Result | 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. | |
| 31249952 | Result |
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| INDUSTRY |
| European Society of Cardiology | NETWORK |
| ANIARA | UNKNOWN |
| University of Aarhus | OTHER |
| Erasmus Medical Center | OTHER |
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| Other |
|
| 2 years |
| Kidney function | Creatinine and Glomerular Filtration Rate calculated by the Cockroft Gault formula | 2 years |
| Side-effects | Bleeding, gastrointestinal side-effects | 2 years |
| Dabigatran plasma concentrations | Measured by liquid-chromatography tandem mass spectrometry (ng/mL) | 2 years |
| Weight | kilograms | 2 years |
| Height | meters | 2 years |
| Waist circumference | centimeters | 2 years |
| Prothrombin time | seconds | 2 years |
| Activated partial thromboplastin time | seconds | 2 years |
| ROTEM | Clotting time (seconds) | 2 years |
| Diluted thrombin time (calibrated for dabigatran) | ng/mL | 2 years |
| Ecarin chromogenic assay | ng/mL | 2 years |
| 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. |
| 29475179 | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D055118 | Medication Adherence |
| D006474 | Hemorrhagic Disorders |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D013927 | Thrombosis |
| D001778 | Blood Coagulation Disorders |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D064419 | Chemically-Induced Disorders |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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