Trial Outcomes & Findings for In Vitro Diagnostic Test for DOAC in Urine (NCT NCT03182829)
NCT ID: NCT03182829
Last Updated: 2022-04-21
Results Overview
Liquid chromatography mass spectrometry versus DOAC Dipstick, qualitative analysis of results
Recruitment status
COMPLETED
Target enrollment
880 participants
Primary outcome timeframe
during urine collection and bioanalytical quantification, any time between August 2018 and April 2019
Results posted on
2022-04-21
Participant Flow
Start of study: 18.08.2018 End of study: 10.04.2019 18 centres
Participant milestones
| Measure |
Factor Xa Inhibitor
The aim was to include 450 patients on stable treatment with apixaban, edoxaban and rivaroxaban
|
Thrombin Inhibitor
The aim was to include 450 patients on stable treatment with dabigatran
|
|---|---|---|
|
Overall Study
STARTED
|
467
|
444
|
|
Overall Study
COMPLETED
|
451
|
429
|
|
Overall Study
NOT COMPLETED
|
16
|
15
|
Reasons for withdrawal
| Measure |
Factor Xa Inhibitor
The aim was to include 450 patients on stable treatment with apixaban, edoxaban and rivaroxaban
|
Thrombin Inhibitor
The aim was to include 450 patients on stable treatment with dabigatran
|
|---|---|---|
|
Overall Study
Protocol Violation
|
12
|
12
|
|
Overall Study
Other
|
4
|
3
|
Baseline Characteristics
In Vitro Diagnostic Test for DOAC in Urine
Baseline characteristics by cohort
| Measure |
Factor Xa Inhibitor
n=451 Participants
Patients on therapy with apixaban, edoxaban and rivaroxaban for at least 7 days
|
Thrombin Inhibitor
n=429 Participants
Patients on therapy with dabigatran for at least 7 days
|
Total
n=880 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
320 Participants
n=99 Participants
|
312 Participants
n=107 Participants
|
632 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
131 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Age, Continuous
|
67 years
n=99 Participants
|
70 years
n=107 Participants
|
68 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
201 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
339 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
250 Participants
n=99 Participants
|
291 Participants
n=107 Participants
|
541 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
|
451 participants
n=99 Participants
|
429 participants
n=107 Participants
|
880 participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
451 participants
n=99 Participants
|
429 participants
n=107 Participants
|
880 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during urine collection and bioanalytical quantification, any time between August 2018 and April 2019Liquid chromatography mass spectrometry versus DOAC Dipstick, qualitative analysis of results
Outcome measures
| Measure |
Factor Xa Inhibitor
n=451 Participants
Patients on treatment with apixaban, edoxaban, rivaroxaban
|
Thrombin Inhibitor
n=429 Participants
Patients treated with dabigatran
|
|---|---|---|
|
Accuracy of Factor Xa and Thrombin Inhibitors Pads of DOAC Dipstick From Urine Samples
|
0.973 percentage of correct responses
Interval 0.96 to 0.982
|
0.993 percentage of correct responses
Interval 0.985 to 0.998
|
Adverse Events
Factor Xa Inhibitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Thrombin Inhibitor
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60