PHAPOCU: Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

Sponsor

Doasense GmbH (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05491460

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation. Special coagulation tests like hemoclot for dabigatran and chromogenic substrate assays for Rivaroxaban, Apixaban, and Edoxaban are time-consuming and can be performed only in specialized laboratories. In specific medical situations like in patients such as emergency procedures, stroke (before starting thrombolytic therapy), trauma, general surgery or other invasive procedures, it may be necessary for medical decision making to know the presence or absence of a DOAC in patient's body fluid. Until now there is no rapid, specific and sensitive coagulation test available in the market.

Condition or Disease	Intervention/Treatment	Phase
Anticoagulant Therapy	Drug: Apixaban 5 MG Tab Drug: Dabigatran 150 MG Tab Drug: Edoxaban 60Mg Tab Drug: Rivaroxaban 20 MG Tab	Phase 1

Detailed Description

This prospective, open-label, controlled, not randomized trial in healthy volunteers to investigate comparatively the pharmacokinetics of the direct oral anticoagulants in plasma and in urine with LC-MS/MS and in urine by DOAC Dipstick.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects

Actual Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Apixaban Volunteers receive one oral dose of 5mg Apxiaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured.	Drug: Apixaban 5 MG Tab oral intake Other Names: Edoxaban, Dabigatran, rivaroxaban
Active Comparator: Dabigatran Volunteers receive one oral dose of 150mg Dabigatran followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured.	Drug: Dabigatran 150 MG Tab oral intake Other Names: Apixaban, Edoxaban, Rivaroxaban
Active Comparator: Edoxaban Volunteers receive one oral dose of 60mg Edoxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured.	Drug: Edoxaban 60Mg Tab oral intake Other Names: Apixaban, Dabigatran, Rivaroxaban
Active Comparator: Rivaroxaban Volunteers receive one oral dose of 20mg Rivaroxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine. Biological and clinical safety parameters are measured.	Drug: Rivaroxaban 20 MG Tab oral intake Other Names: Apixaban, Edoxaban, Dabigatran

Outcome Measures

Primary Outcome Measures

Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS [up to 6 months]
Assess the accuracy and specificity of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients 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

Comparison of qualitative POCT with quantitative LC-MS/MS [up to 6 months]
Comparison of qualitative POCT with quantitative LC-MS/MS Investigator readings of POCT test results as compared to LC-MS/MS
Questionnaire on handling and usability [up to 6 months]
Specific questions to be answered using Lickert scale by personal performing the test

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Fully signed and dated written informed consent
Age >18 years
healthy

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.