Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects (PHAPOCU)

Doasense

Status and phase: Active, not recruiting; Phase 1

Conditions: Anticoagulant Therapy

Treatments: Drug: Edoxaban 60Mg Tab; Drug: Apixaban 5 MG Tab; Drug: Dabigatran 150 MG Tab; Drug: Rivaroxaban 20 MG Tab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05491460

PhaKiDo-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

Apixaban

Active Comparator group

Description:

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.

Treatment:

Drug: Apixaban 5 MG Tab

Dabigatran

Active Comparator group

Description:

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.

Treatment:

Drug: Dabigatran 150 MG Tab

Edoxaban

Active Comparator group

Description:

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.

Treatment:

Drug: Edoxaban 60Mg Tab

Rivaroxaban

Active Comparator group

Description:

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.

Treatment:

Drug: Rivaroxaban 20 MG Tab