CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 880 enrolled
Drug / intervention
DOAC Dipstickother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03182829
NCT03182829N/ACompleted
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Post Marketing Study of an in Vitro Diagnostic Test for Direct Oral Anticoagulants (Apixaban, Edoxaban, Rivaroxaban, Dabigatran) in Urine

Doasense GmbH·observational·Posted Jun 9, 2017·Updated Apr 21, 2022

In Brief

An observational study evaluating DOAC Dipstick for Anticoagulant Therapy. Completed, enrolled 880 participants across 18 sites.

Detailed 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. \[Epub ahead of print\]"

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAnticoagulant Therapy
CountriesGermany
CollaboratorsCRS Clinical Research Services Mannheim GmbH, Heidelberg University, Medical Care Center Dr. Limbach and Colleagues, Heidelberg, Germany

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJun 9, 2017
Enrollment StartAug 22, 2018
Primary CompletionApr 9, 2019
Study CompletionJun 5, 2019
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.1 years ago

Interventions

DOAC Dipstickother

Patients collect a sample of urine for analysis. "publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. \[Epub ahead of print\]"