AnticoagulationUniXaNCT04539301
Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels
An observational study of Anticoagulation and Venous Thromboembolism, run by Nantes University Hospital at 1 site in France.
Trial summary
Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation, Venous Thromboembolism, Atrial Fibrillation
- What is being tested?
- Estimated anticoagulant level (conversion factor x anti-Xa activity)
- How many people
- 2,100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 May 2024
- 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: Adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux
Who may be able to join
- Blood sample from adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux
Who cannot join
- Patients treated with unfractionated heparin or low molecular weight heparin
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Nantes University Hospital
Nantes, Loire-Atlantique, 44093
About this study
Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid levels.
- Conditions
- Anticoagulation, Venous Thromboembolism, Atrial Fibrillation
- Being tested
- Estimated anticoagulant level (conversion factor x anti-Xa activity)
- Keywords
- Anticoagulants (MeSH), Blood Coagulation Tests (MeSH), Drug monitoring (MeSH), Factor Xa Inhibitors (MeSH), Heparin (MeSH)
- Medical subject headings
- Venous Thromboembolism, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estimated anticoagulant level (conversion factor x anti-Xa activity)Diagnostic test
Estimated anticoagulant level (conversion factor x anti-Xa activity)
| Study group | Role | What they receive |
|---|---|---|
| Derivation cohort | In the derivation cohort, we will determined the conversion factor linking apixaban, rivaroxaban, fondaparinux, or danaparoid measured level, on the one hand, and heparin anti-Xa activity, on the other hand. Receives: Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity) | |
| Validation cohort | In the validation cohort, for each tested anticoagulant, we will used the conversion factor determined in the derivation cohort to infer the estimated level of anticoagulant from heparin anti-Xa activity:
estimated anticoagulant level = conversion factor for this anticoagulant × heparin anti-Xa activity
The agreement between measured and estimated levels of each factor-Xa inhibitor will be assessed. Receives: Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between measured and estimated levels of each factor-Xa inhibitor
An estimated anticoagulant level between 80 and 120% of the value obtained by the reference method ("specific assay") will be deemed clinically acceptable, i.e. the patient's management would have been the same.
Measured: 2 years
Secondary outcomes (2)
Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program
Measured: 2 years
Cost comparison (estimated anticoagulant level method versus specific dosage)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Apr 2021
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies 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
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539301
- Sponsor's protocol ID
- RC20_0061
- Acronym
- UniXa
- Status last verified
- May 2024
- First submitted
- 1 Sep 2020
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels
- ClinicalTrials.gov ID
- NCT04539301
- Acronym / sponsor ID
- UniXa / RC20_0061
- Conditions
- Anticoagulation, Venous Thromboembolism, Atrial Fibrillation
- Keywords
- Anticoagulants (MeSH), Blood Coagulation Tests (MeSH), Drug monitoring (MeSH), Factor Xa Inhibitors (MeSH), Heparin (MeSH)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 4 Sep 2020 (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.
Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Derivation cohort | – | Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)In the derivation cohort, we will determined the conversion factor linking apixaban, rivaroxaban, fondaparinux, or danaparoid measured level, on the one hand, and heparin anti-Xa activity, on the other hand. |
| Validation cohort | – | Diagnostic Test: Estimated anticoagulant level (conversion factor x anti-Xa activity)In the validation cohort, for each tested anticoagulant, we will used the conversion factor determined in the derivation cohort to infer the estimated level of anticoagulant from heparin anti-Xa activity: estimated anticoagulant level = conversion factor for this anticoagulant × heparin anti-Xa activity The agreement between measured and estimated levels of each factor-Xa inhibitor will be assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux
Key inclusion criteria (1 listed)
- Blood sample from adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux
Key exclusion criteria (1 listed)
- Patients treated with unfractionated heparin or low molecular weight heparin
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 |
|---|---|---|
| Estimated anticoagulant level (conversion factor x anti-Xa activity)Estimated anticoagulant level (conversion factor x anti-Xa activity) | Diagnostic test | Derivation cohort, Validation cohort |
Primary outcome
Agreement between measured and estimated levels of each factor-Xa inhibitor
Time frame: 2 years
An estimated anticoagulant level between 80 and 120% of the value obtained by the reference method ("specific assay") will be deemed clinically acceptable, i.e. the patient's management would have been the same.
2 secondary outcomes
Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program
Time frame: 2 years
Cost comparison (estimated anticoagulant level method versus specific dosage)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anticoagulation and Venous Thromboembolism, run by Nantes University Hospital at 1 site in France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elodie BOISSIER (330240165465, elodie.boissier@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between measured and estimated levels of each factor-Xa inhibitor (time frame: 2 years). 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 7 May 2024.