Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anticoagulant Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Apixaban 5 MG Tab

Intervention Type DRUG

oral intake

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.

Group Type ACTIVE_COMPARATOR

Dabigatran 150 MG Tab

Intervention Type DRUG

oral intake

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.

Group Type ACTIVE_COMPARATOR

Edoxaban 60Mg Tab

Intervention Type DRUG

oral intake

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.

Group Type ACTIVE_COMPARATOR

Rivaroxaban 20 MG Tab

Intervention Type DRUG

oral intake

Interventions

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Apixaban 5 MG Tab

oral intake

Intervention Type DRUG

Dabigatran 150 MG Tab

oral intake

Intervention Type DRUG

Edoxaban 60Mg Tab

oral intake

Intervention Type DRUG

Rivaroxaban 20 MG Tab

oral intake

Intervention Type DRUG

Other Intervention Names

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Edoxaban, Dabigatran, rivaroxaban Apixaban, Edoxaban, Rivaroxaban Apixaban, Dabigatran, Rivaroxaban Apixaban, Edoxaban, Dabigatran

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes