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NCT03073265 · ClinicalTrials.gov registry record
Apixaban Validation Study - Additional Study on Fresh Samples
A clinical trial of Anticoagulation With Apixaban, sponsored by Diagnostica Stago.
- Completed
- Registry status
- 109
- Enrollment target
- 2
- Study locations
NCT03073265: Completed study of Anticoagulation With Apixaban, sponsored by Diagnostica Stago.
NCT03073265 is a study of Anticoagulation With Apixaban that has completed, run by Diagnostica Stago. The registered enrollment target is 109 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03073265, a study of Anticoagulation With Apixaban, has completed, sponsored by Diagnostica Stago.
- COMPLETED
- Registry status
- 109 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography - mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be performed on fresh samples only. The results will be used to complete results obtained previously on frozen samples.
Primary Outcome
Compare results from anti-Xa assay and LCMS to measure apixaban in plasma samples. Regression and difference charts will be used to compare the methods.
Conditions Studied
Interventions
- DEVICE STA-Apixaban Calibrator & Control
Study Locations (2)
North Carolina
- Moses Cone Memorial Hospital - Greensboro
Pennsylvania
- Lehigh Valley Health Nrwork - Allentown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2017-05-08 |
| Est. Completion | 2017-11-01 |
What the finished NCT03073265 record still lists
NCT03073265 is an observational study that tracks outcomes without assigning an intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Anticoagulation With Apixaban appearing as the primary indexed condition, and to 1 intervention - of which STA-Apixaban Calibrator & Control is the first listed.
NCT03073265 reports a single indexed study location in North Carolina, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03073265 about?
NCT03073265 is a clinical study titled "Apixaban Validation Study - Additional Study on Fresh Samples". The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography - mass spectrometry) for validation of...
What is the current status of trial NCT03073265?
This trial is currently completed. The enrollment target is 109 participants. The study started on 2017-05-08. Estimated completion is 2017-11-01.
What conditions does trial NCT03073265 study?
This clinical trial studies the following conditions: Anticoagulation With Apixaban.
What interventions are being tested in trial NCT03073265?
The interventions under investigation include: STA-Apixaban Calibrator & Control (DEVICE).
Who is sponsoring clinical trial NCT03073265?
This trial is sponsored by Diagnostica Stago, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03073265 being conducted?
This trial has 2 study locations across North Carolina, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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