Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

NCT05491460 | Unknown Phase 1 DMC

• 1 other identifier: PhaKiDo-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulant Therapy

Keywords

anticoagulant; direct oral anticoagulant; apixaban; edoxaban; rivaroxaban; dabigatran; coagulation; point of care method

Outcome Measures

Primary Outcomes (1)

• Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS

  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

  up to 6 months

Secondary Outcomes (2)

• Comparison of qualitative POCT with quantitative LC-MS/MS

  up to 6 months

• Questionnaire on handling and usability

  up to 6 months

Study Arms (4)

Apixaban

ACTIVE COMPARATOR

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

Dabigatran

ACTIVE COMPARATOR

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

Edoxaban

ACTIVE COMPARATOR

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

Rivaroxaban

ACTIVE COMPARATOR

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

Interventions

Apixaban 5 MG Tab DRUG

oral intake

Also known as: Edoxaban, Dabigatran, rivaroxaban

Apixaban

Dabigatran 150 MG Tab DRUG

oral intake

Also known as: Apixaban, Edoxaban, Rivaroxaban

Dabigatran

Edoxaban 60Mg Tab DRUG

oral intake

Also known as: Apixaban, Dabigatran, Rivaroxaban

Edoxaban

Rivaroxaban 20 MG Tab DRUG

oral intake

Also known as: Apixaban, Edoxaban, Dabigatran

Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Doasense GmbH: lead

Study Sites (1)

Clincial Research Serivces

Mannheim, 68167, Germany

Location

Related Publications (1)

• Harenberg J, Schreiner R, Hetjens S, Weiss C. Detecting Anti-IIa and Anti-Xa Direct Oral Anticoagulant (DOAC) Agents in Urine using a DOAC Dipstick. Semin Thromb Hemost. 2019 Apr;45(3):275-284. doi: 10.1055/s-0038-1668098. Epub 2018 Aug 22.

  PMID: 30134449 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

apixaban; edoxaban; Dabigatran; Rivaroxaban

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Study Officials

• Armin Schultz, MD

  Clinical Research Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: August 8, 2022
• Study Start: July 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08

Locations

DE (1)