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In Vitro Diagnostic Test for DOAC in Urine (PADOASU)

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ClinicalTrials.gov Identifier: NCT03182829
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 7, 2019
Sponsor:
Collaborators:
Clinical Research Services, Mannheim, Germany
Institute Medical Statistics, Medical Faculty Mannheim
Medical Care Center Dr. Limbach and Colleagues, Heidelberg, Germany
Information provided by (Responsible Party):
Doasense GmbH

Brief Summary:

This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants Apixaban, Edoxaban, Rivaroxaban, and Dabigatran (DOAC) in an actual point-of-care (POCT) setting in comparison to results obtained by liquid chromatography tandem mass spectrometry (LC-MS/MS) from urine samples.

This trial is conducted to assess the performance and handling of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with DOACs in an actual point-of-care setting in comparison to results obtained by liquid chromatography tandem mass spectrometry (LC-MS/MS) from urine samples.


Condition or disease Intervention/treatment
Anticoagulant Therapy Diagnostic Test: DOAC Dipstick

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 880 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Post Marketing Study of an in Vitro Diagnostic Test for Direct Oral Anticoagulants (Apixaban, Edoxaban, Rivaroxaban, Dabigatran) in Urine
Actual Study Start Date : August 22, 2018
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Factor Xa inhibitor
Patients on treatment with Apixaban, Edoxaban or Rivaroxaban are included into the evaluation study at the outpatient care unit. Patients receive treatment for a specific clinical indication such as non-valvular atrial fibrillation or venous thromboembolism since one week or longer. During the study visit DOAC Dipstick test and liquid-chromatography mass-specrotmery are performed to identify absence or presence of Factor Xa inhibitor in urine.
Diagnostic Test: DOAC Dipstick
Patients collect a sample of urine for analysis.
Other Name: test strip for urine analysis

Thrombin inhibitor
Patients on treatment with Dabigatran are included included into the evaluation study at the outpatient care unit. Patients receive treatment for a specific clinical indication such as non-valvular atrial fibrillation or venous thromboembolism since one week or longer. During the study visit DOAC Dipstick test and liquid-chromatography mass-specrotmery are performed to identify absence or presence of Thrombin inhibitor in urine.
Diagnostic Test: DOAC Dipstick
Patients collect a sample of urine for analysis.
Other Name: test strip for urine analysis




Primary Outcome Measures :
  1. Assess the accuracy and specificity of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients [ Time Frame: August 2018 to March 2019 ]
    True positive and true negative rate of the point of care test (POCT) by comparison with the results obtained by bioanalytical quantification


Secondary Outcome Measures :
  1. Comparison of qualitative POCT with quantitative LC-MS/MS [ Time Frame: August 2018 to March 2019 ]
    Investigator readings of POCT test results as compared to LC-MS/MS

  2. Questionnaire on handling and usability [ Time Frame: August 2018 to March 2019 ]
    Specific questions to be answered using Lickert scale by personal performing the test


Biospecimen Retention:   Samples Without DNA
urine sample, spontaneously collected from patients


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients on routine treatment with Apixaban, Dabigatran, Edoxaban, and Rivaroxaban since 1 week or longer, an age of >18 years and fulfilling none the exclusion criteria are eligible. The patients participating in this Performance Assessment will be recruited directly at the point of care, i.e., the respective outpatient care unit.
Criteria

Inclusion Criteria:

  • Fully signed and dated written informed consent
  • Age >18 years
  • Patient is either under therapy with rivaroxaban, apixaban, and edoxaban or dabigatran for at least 1 week

Exclusion Criteria:

  • Patients not able to provide urine samples.
  • Patients not able to understand the informed consent or severe mentally disabled.
  • Patients in the end-stage of a severe disease.

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): NCT03182829


Locations
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Germany
Universitätsherzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie II
Bad Krozingen, Germany, 79189
Herz- und Diabeteszentrum NRW, Klinik für Kardiologie
Bad Oeynhausen, Germany, 32545
Vivantes Klinikum im Friedrichshain
Berlin, Germany, 10249
Gerinnungszentrum Sucker
Berlin, Germany, 10789
Vivantes Klinikum Neukölln
Berlin, Germany, 12351
Klinikum Coburg GmbH, II. Medizinische Klinik
Coburg, Germany, 96450
Klinikum Darmstadt - Gefäßzentrum
Darmstadt, Germany, 64283
Praxis Innere Medizin, Kardiologie und Angiologie
Dessau, Germany, 06846
Städtisches Klinikum Dresden, II. Medizinische Klinik
Dresden, Germany, 01067
Medizinische Fakultät Carl Gustav Carus, Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany, 60389
Klinik für Kardiologie und Angiologie I
Freiburg, Germany, 79106
Justus-Liebig-Universität Gießen, Interdisziplinärer Schwerpunkt für Hämostaseologie
Gießen, Germany, 35392
Universitätsklinikum Hamburg-Eppendorf, II. Medizinische Klinik und Poliklinik
Hamburg, Germany, 20246
Pneumonologische Schwerpunktpraxis Heidelberg, Privatpraxis Harenberg
Heidelberg, Germany, 69121
Kliniken Landkreis Heidenheim
Heidenheim, Germany, 89522
Krankenhaus der Augustinerinnen gGmbH, Klinik für Kardiologie und internistische Intensivmedizin
Köln, Germany, 50678
Zentrum für Blutgerinnungsstörungen, MVZ Labor Dr. Reising-Ackermann und Kollegen
Leipzig, Germany, 04289
Zentrum für Praevention und Rehabilitation
Siegen, Germany, 57072
Die Parkkardiologie
Stahnsdorf, Germany, 14532
Sponsors and Collaborators
Doasense GmbH
Clinical Research Services, Mannheim, Germany
Institute Medical Statistics, Medical Faculty Mannheim
Medical Care Center Dr. Limbach and Colleagues, Heidelberg, Germany
Investigators
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Principal Investigator: Job Harenberg, Professor Pneumonologische Schwerpunktpraxis Heidelberg, Privatpraxis Harenberg

Additional Information:
Publications:
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Responsible Party: Doasense GmbH
ClinicalTrials.gov Identifier: NCT03182829     History of Changes
Other Study ID Numbers: DOA-CS-002
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual data of patients are collected during the study and stored centrally at DOASENSE GmbH Heidelberg, Germany. They will be shared with other researchers upon request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Doasense GmbH:
point of care test
coagulation test
POC test
direct oral anticoagulants
apixaban
dabigatran
edoxaban
rivaroxaban
urine
LC-MS/MS
evaluation study
blood coagulation
anticoagulant
thrombosis
pulmonary embolism
atrial fibrillation
anticoagulation
mass spectrometry

Additional relevant MeSH terms:
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Rivaroxaban
Apixaban
Edoxaban
Factor Xa Inhibitors
Dabigatran
Anticoagulants
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action