N/A N=911

In Vitro Diagnostic Test for DOAC in Urine

Anticoagulant Therapy

Bottom Line

View on ClinicalTrials.gov: NCT03182829 ↗

Enrolled (actual)

911

Serious AEs

—

Results posted

May 2021

Primary outcome: Primary: Accuracy of Factor Xa and Thrombin Inhibitors Pads of DOAC Dipstick From Urine Samples — 0.973; 0.993 percentage of correct responses — p=<0.05

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: DOAC Dipstick (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Doasense GmbH
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of Factor Xa and Thrombin Inhibitors Pads of DOAC Dipstick From Urine Samples	0.973; 0.993	<0.05 sig

Summary

This trial is conducted to assess the performance and handling of the in vitro diagnostic (IVD) device for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with direct oral anticoagulants Apixaban, Edoxaban, Rivaroxaban, and Dabigatran (DOAC) in an actual point-of-care (POCT) setting in comparison to results obtained by liquid chromatography tandem mass spectrometry (LC-MS/MS) from urine samples. This trial is conducted to assess the performance and handling of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients on treatment with DOACs in an actual point-of-care setting in comparison to results obtained by liquid chromatography tandem mass spectrometry (LC-MS/MS) from urine samples. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. [Epub ahead of print]"

Eligibility Criteria

Inclusion Criteria

Fully signed and dated written informed consent
Age >18 years
Patient is either under therapy with rivaroxaban, apixaban, and edoxaban or dabigatran for at least 1 week

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.

"publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. [Epub ahead of print]"

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03182829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.