Anticoagulation With ApixabanNCT03073265
Apixaban Validation Study - Additional Study on Fresh Samples
An observational study of Anticoagulation With Apixaban, run by Diagnostica Stago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation With Apixaban
- Type of treatment
- Medical device
- How many people
- 109 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2017to 1 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with apixaban presenting at least one of the listed inclusion criteria.
Who may be able to join
- Age ≥ 75 years,
- Weight ≤ 60 kg,
- Haematocrit below normal values as determined by local laboratory or < 40% for male and < 37% for female
- Renal impairment documented (creatinine clearance ≤ 80 mL/min as per Cockcroft -Gault equation) or serum creatinine ≥ 1.5 mg/dL
- Co-medication with aspirin or any other NSAIDs (nonsteroidal anti-inflammatory drugs)
- Co-medication with anti-platelet agents
Who cannot join
- Patients less than 18 years old
- Patients under other anti-coagulant treatment
- Samples that are not collected, stored, or handled in accordance with sample collection procedures defined above.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lehigh Valley Health Nrwork
Allentown, Pennsylvania, 18101
Moses Cone Memorial Hospital
Greensboro, North Carolina, 27401
About this study
Official title: Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control
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.
Read the detailed description
About 60 samples from patients on apixaban meeting inclusion/exclusion criteria will be included in this study. Two sites will be in charge of sample recruitment and anti-Xa testing. A third site will be in charge of LCMS testing.
- Conditions
- Anticoagulation With Apixaban
- Being tested
- STA-Apixaban Calibrator & Control
- Keywords
- DOAC, apixaban, IVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STA-Apixaban Calibrator & ControlDevice
Measurement of apixaban level will be done using anti-Xa assay (IVD).
| Study group | Role | What they receive |
|---|---|---|
| Patients on apixaban | Patients currently on apixaban who meet inclusion/exclusion criteria A blood draw will be done on each patient to measure apixaban concentration in plasma using anti-Xa assay and LCMS. Receives: Device: STA-Apixaban Calibrator & Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma
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.
Measured: The anti-Xa assay will be tested within 6h after sample collection and LCMS will be performed on frozen samples, at maximum 2 months after collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start8 May 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anticoagulation With ApixabanStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diagnostica Stago
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073265
- Sponsor's protocol ID
- VSP A006 - US_comp / 1
- Status last verified
- May 2017
- First submitted
- 27 Feb 2017
- Last updated
- 9 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control
- ClinicalTrials.gov ID
- NCT03073265
- Acronym / sponsor ID
- VSP A006 - US_comp / 1
- Conditions
- Anticoagulation With Apixaban
- Keywords
- DOAC, apixaban, IVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Diagnostica StagoIndustry (pharma, biotech, devices)
- Study start
- 8 May 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
About 60 samples from patients on apixaban meeting inclusion/exclusion criteria will be included in this study. Two sites will be in charge of sample recruitment and anti-Xa testing. A third site will be in charge of LCMS testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on apixaban | – | Device: STA-Apixaban Calibrator & ControlPatients currently on apixaban who meet inclusion/exclusion criteria A blood draw will be done on each patient to measure apixaban concentration in plasma using anti-Xa assay and LCMS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with apixaban presenting at least one of the listed inclusion criteria.
Key inclusion criteria (6 listed)
- Age ≥ 75 years,
- Weight ≤ 60 kg,
- Haematocrit below normal values as determined by local laboratory or < 40% for male and < 37% for female
- Renal impairment documented (creatinine clearance ≤ 80 mL/min as per Cockcroft -Gault equation) or serum creatinine ≥ 1.5 mg/dL
- Co-medication with aspirin or any other NSAIDs (nonsteroidal anti-inflammatory drugs)
Key exclusion criteria (3 listed)
- Patients less than 18 years old
- Patients under other anti-coagulant treatment
- Samples that are not collected, stored, or handled in accordance with sample collection procedures defined above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STA-Apixaban Calibrator & ControlMeasurement of apixaban level will be done using anti-Xa assay (IVD). | Device | Patients on apixaban |
Primary outcome
Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma
Time frame: The anti-Xa assay will be tested within 6h after sample collection and LCMS will be performed on frozen samples, at maximum 2 months after collection.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation With Apixaban, run by Diagnostica Stago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma (time frame: The anti-Xa assay will be tested within 6h after sample collection and LCMS will be performed on frozen samples, at maximum 2 months after collection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.