Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

Anticoagulant Therapy Clinical Trial

— PHAPOCU  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05491460
• Other study ID #: PhaKiDo-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: July 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Doasense GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulant Therapy

Intervention

Drug:
• Apixaban 5 MG Tab
oral intake
• Dabigatran 150 MG Tab
oral intake
• Edoxaban 60Mg Tab
oral intake
• Rivaroxaban 20 MG Tab
oral intake

Locations

Country	Name	City	State
Germany	Clincial Research Serivces	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Doasense GmbH

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparison of qualitative POCT with quantitative LC-MS/MS	Comparison of qualitative POCT with quantitative LC-MS/MS Investigator readings of POCT test results as compared to LC-MS/MS	up to 6 months
Secondary	Questionnaire on handling and usability	Specific questions to be answered using Lickert scale by personal performing the test	up to 6 months