N/A
Completed N=911
In Vitro Diagnostic Test for DOAC in Urine
Anticoagulant Therapy
Source: ClinicalTrials.gov NCT03182829 ↗
Enrolled (actual)
911
Serious AEs
—
Results posted
May 2021
Primary outcomePrimary: 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
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]"
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 |
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]"
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. Informational only — not medical advice.