NCT05491460

Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Doasense GmbH · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Anticoagulant Therapy

Interventions

Type	Name	Description
DRUG	Apixaban 5 MG Tab	oral intake
DRUG	Dabigatran 150 MG Tab	oral intake
DRUG	Edoxaban 60Mg Tab	oral intake
DRUG	Rivaroxaban 20 MG Tab	oral intake

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-08-08
• Last updated: 2022-08-08

Locations

1 site across 1 country: Germany