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Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects

NCT05491460 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-08-08

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Doasense GmbH

    lead INDUSTRY

Principal Investigators

  • Armin Schultz, MD · Clinical Research Services

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-12-30
Completion
2023-12-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491460 on ClinicalTrials.gov