Antiphospholipid SyndromeLYON SAPLNCT03890601
New Biological Tests in Patients With Antiphospholipid Antibodies
An observational study of Antiphospholipid Syndrome, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antiphospholipid Syndrome
- What is being tested?
- blood sample
- How many people
- 74 participants
- Where
- 5 sitesFrance
- Study dates
- 13 Mar 2019to 22 May 2023
- 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: 150 adult patients with known aPL-Abs (Antiphospholipid antibodies) will be including in the study after collecting their informed consent.
Who may be able to join
- Adult patients with confirmed aPL-Abs (at least two positive determinations at least 12 week apart)
- Subject non opposition
Who cannot join
- Age < 18 years
- Patient under the protection of justice, under guardianship or under curatorship
- Patient with anticoagulant treatment, except heparin
- Clinically symptomatic liver disease, supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT superior or egal to 5 seconds above upper normal limit
- Platelet count < 100 G/L (giga/liter)
- Poor venous access
- Non confirmed suspicion of APS
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Cardiologique Louis Pradel
Bron, 69500
CHU de Clermont-Ferrand
Clermont-Ferrand, 63003
Hôpital de la Croix-Rousse
Lyon, 69004
Hôpital Edouard Herriot
Lyon, 69421
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
About this study
Official title: Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research.
The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Test (TGT) parameters: endogen thrombin potential (ETP), lag time and time to peak) will be compared to the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
- Conditions
- Antiphospholipid Syndrome
- Being tested
- blood sample
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
A single 15 mL blood draw is planned for this study, as follow:
- 10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA
- 5 mL EDTA tube for blood count
During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1.
| Study group | Role | What they receive |
|---|---|---|
| Biological APS | 50 Asymptomatic patients with aPL antibodies and prolonged APTT Receives: Biological: blood sample | |
| Obstetrical APS | 50 patients with Obstetrical aPL syndrome Receives: Biological: blood sample | |
| Thrombosis APS | APS with a personal history of venous or arterial thrombosis (50 patients) Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
aβ2GP1-dm
The hypercoagulability status will be compared in each group. Each biological result of aβ2GP1-dm1 will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Measured: One day
Endogenous Thrombin Potential (ETP)
The hypercoagulability status will be compared in each group. Each biological result of ETP will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Measured: One day
peak of thrombin
The hypercoagulability status will be compared in each group. Each biological result of peak of thrombin will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Measured: One day
lag time
The hypercoagulability status will be compared in each group. Each biological result of lag time will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Measured: One day
time to peak
The hypercoagulability status will be compared in each group. Each biological result of time to peak will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start13 Mar 2019
- Primary completion22 May 2023
- Study completion22 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890601
- Sponsor's protocol ID
- 69HCL18_0522
- Other IDs
- 2018-A03020-55
- Acronym
- LYON SAPL
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2019
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domain 1 of β2-Glycoprotein 1 Autoantibodies and Thrombin Generation Capacity in Patients With Antiphospholipid Antibodies
- ClinicalTrials.gov ID
- NCT03890601
- Acronym / sponsor ID
- LYON SAPL / 69HCL18_0522
- Conditions
- Antiphospholipid Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 26 Mar 2019 (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.
Antiphospholipid syndrome (APS) is an autoimmune disease characterized by thromboembolic events or pregnancy complications associated with circulating antiphospholipid antibodies (aPL-Abs). APS diagnosis needs the presence of both clinical and serological criteria (SAPORRO criteria, updated with Sydney criteria in 2006). However, no correlation between laboratory assays and the clinical thrombosis risk in patients with aPL-Abs was observed as only few patients with aPL-Abs developed clinical manifestations. Thrombin generation assays (TGA) is a global coagulation test that may represent a certain interest to evaluate thrombosis risk as a high thrombin generation capacity seems to be an independent risk factor for recurrent thromboembolic events. Another point of interest to assess the thrombotic risk is the detection of autoantibodies recognizing domain 1 of β2Gp1 (aβ2GP1-dm1). These autoantibodies are strongly related correlated with thrombotic and pregnancy manifestations. Recently, a commercial chemiluminescence immunoassay (CLIA) for detection of aβ2GP1-dm1 became available on Acustar® analyzer (HemosIL Acustar®, Instrument Laboratory, Bedford, USA) to facilitate aβ2GP1-dm1 research.
The aim of this study is to evaluate two additional laboratory assays to improve the correlation between laboratory assays and the clinical thrombosis risk in patients with antiphospholipid (APL): thrombin generation assay and aβ2GP1-dm1. Each biological result (Antibodies to Domain 1 (Dm1) of β2-Glycoprotein 1 (aβ2GP1-dm1) and Thrombin Generation Test (TGT) parameters: endogen thrombin potential (ETP), lag time and time to peak) will be compared to the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biological APS | – | Biological: blood sample50 Asymptomatic patients with aPL antibodies and prolonged APTT |
| Obstetrical APS | – | Biological: blood sample50 patients with Obstetrical aPL syndrome |
| Thrombosis APS | – | Biological: blood sampleAPS with a personal history of venous or arterial thrombosis (50 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 150 adult patients with known aPL-Abs (Antiphospholipid antibodies) will be including in the study after collecting their informed consent.
Key inclusion criteria (2 listed)
- Adult patients with confirmed aPL-Abs (at least two positive determinations at least 12 week apart)
- Subject non opposition
Key exclusion criteria (7 listed)
- Age < 18 years
- Patient under the protection of justice, under guardianship or under curatorship
- Patient with anticoagulant treatment, except heparin
- Clinically symptomatic liver disease, supported by e.g. diagnosis of cirrhosis, portal hypertension, ascites, PT superior or egal to 5 seconds above upper normal limit
- Platelet count < 100 G/L (giga/liter)
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 |
|---|---|---|
| blood sampleA single 15 mL blood draw is planned for this study, as follow: * 10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA * 5 mL EDTA tube for blood count During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1. | Biological | Biological APS, Obstetrical APS, Thrombosis APS |
Primary outcome
aβ2GP1-dm
Time frame: One day
The hypercoagulability status will be compared in each group. Each biological result of aβ2GP1-dm1 will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
Endogenous Thrombin Potential (ETP)
Time frame: One day
The hypercoagulability status will be compared in each group. Each biological result of ETP will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
peak of thrombin
Time frame: One day
The hypercoagulability status will be compared in each group. Each biological result of peak of thrombin will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
lag time
Time frame: One day
The hypercoagulability status will be compared in each group. Each biological result of lag time will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
time to peak
Time frame: One day
The hypercoagulability status will be compared in each group. Each biological result of time to peak will be compared to a gold standard: the history of clinical thrombosis (venous or arterial thrombosis and/or obstetrical complications such as defined by the Saporro criteria updated with Sydney criteria in 2006) for each patient.
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 21 Aug 2026.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antiphospholipid Syndrome, run by Hospices Civils de Lyon at 5 sites 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 2 inclusion and 7 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 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
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?
aβ2GP1-dm (time frame: One day). The study lists 5 primary outcomes in all. 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 21 Aug 2026.