An observational study in Antiphospholipid Syndrome (APS), Cohort Study and Thrombotic and Bleeding Events, sponsored by Central Hospital, Nancy, France. Not yet recruiting at 13 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Central Hospital, Nancy, France · Observational
Among 31 studies in Antiphospholipid Syndrome with a site in France — 11 open to participants now, 11 under way, 1 of them phase 3. Antiphospholipid Syndrome · France.
Among the 31 studies in Antiphospholipid Syndrome with a site in France, this one is the 9th largest by planned enrollment of the 17 observational ones that give a count, is one of 3 that started in 2025, is one of 17 observational ones, reaches primary completion later than 9 of the 10 other live ones, and was the 26th registered.
121 studies on the registry are indexed under Antiphospholipid Syndrome; 52 are open to participants now.
Browse Antiphospholipid Syndrome studies →11 of the 31 studies in Antiphospholipid Syndrome with a site in France are open now. Recruiting first, the newest first:
University Hospital, Strasbourg, France · Sites in France
Ages 18–70
CHU de Reims · Sites in France
Ages 65+
Centre Hospitalier Universitaire, Amiens · Sites in France
Ages 18+ · Healthy volunteers
Chugai Pharmaceutical · Sites in France, United States, Australia and 17 more countries
Ages 18–85
Central Hospital, Nancy, France · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 38 Antiphospholipid Syndrome studies recruiting now, 14 (37%) set no upper age limit and 19 (50%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 310 is above the median of 156 across 50 observational studies indexed under Antiphospholipid Syndrome.
Median enrollment 102 across the 14 interventional studies, 310 across the 17 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
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2 of 31 have an industry lead sponsor. The 10 most frequent:
Central Hospital, Nancy, France is the lead sponsor of 798 studies on the registry; 186 are open to participants now.
Central Hospital, Nancy, France has 7 studies filed under Antiphospholipid Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Antiphospholipid Syndrome with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06371417Chugai PharmaceuticalPhase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | 2027-03-31 |
| NCT07178925University Hospital, RouenFollow-up Cohort of Patients With Antiphospholipid Syndrome | 2027-10-16 |
Add all 2 to your calendar (.ics) → With an account.
Among the 31 studies in Antiphospholipid Syndrome with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Antiphospholipid syndrome (APS) is a thrombotic disease requiring prolonged anticoagulation. Direct oral anticoagulants (DOACs) are indicated as 1st-line therapy in venous thrombosis, compared with VKAs, due to their easier handling and lower bleeding risk for equivalent efficacy. In APS, VKAs are still the reference treatment. However, DOACs are generally introduced in the acute phase of venous, before the diagnosis of APS. VKA have the disadvantage of numerous food and drug interactions, and therefore require close monitoring of INR, at least once a month. Because they are easier to use than VKAs, and the risk of bleeding is lower, patients are often reluctant to switch from DOACs to VKA. Studies have shown that APS patients with high thrombotic risk (positivity of all three antiphospholipid tests, history of arterial or small vessels thrombosis or cardiac valve damage) have an increased thrombotic risk during DOACs vs. VKA treatment. Since 2020, the ISTH guidelines have suggested avoiding DOACs in high-risk APS, but suggest continuing theim in other patients if they were introduced for venous thrombosis and if follow-up on DOACs is reassuring. In the case of high-risk APS patients, the relay is therefore systematic. For non-high-risk patients (the majority), there are no data to justify systematic switch. Given the quality-of-life advantages of DOACs over VKAs, patients are not always in favor of changing their anticoagulant therapy, especially if they have been on it for many years with good tolerability. For these reasons, a number of patients with non-high-risk APS remain on DOACs. Nevertheless, the limited data available on the efficacy of DOACs in non-high-risk patients are of low level of evidence and contradictory. In 2020, a literature review of non-high-risk SAPL patients treated with DOACs reported that 8.6% of them experienced thrombotic recurrence within 12 months, with no possible comparison with VKAs. A recent retrospective study with 96 patients reported that 15.4% of patients treated with DOACs had a recurrence, compared to 5.3% on VKAs. However, this difference was not statistically significant (p=0.15) due to a clear lack of power. The objective is to determine the frequency of thrombotic recurrences and to compare it according to the type of oral treatment, anti-Xa versus VKA, in non-high-risk APS, through a cohort study with prospective follow-up. The patient's usual antithrombotic treatment, DOAC and VKA, will be continued unchanged.
prospective cohort of APS patient treated with VKA or DOACs (specially oral Xa treatment).
APS patients will be non high risk patients (no triple positivity, any previous arterial or small vessels thrombosis or cardiac involvment).
the treatment taken by the patient at inclusion will not be modified. There will therefore be no change to the patient's usual management.
all patients will have a blood sample taken at inclusion as part of a routine blood test.
Patients will be prospectively follow up and the level of recurrence thrombotic event will be recorded
Population of "non-high-risk" thrombotic APS patients treated with oral AntiXa or VKA regarding the treatment already taken at inclusion. Non-high-risk" APS is defined by no history of arterial or small vessels thrombosis, any valvulopathy related to APS, and a biological profile with only one or two positive antiphospholipid tests.
Patients will be recruited via the departments authorized to manage them, during their consultation or hospitalization. Patients will be invited to participate in the study as part of their regular follow-up visit. There will be no change in current antithrombotic treatment at the time of inclusion.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Carrier of venous thrombotic SAPL:
With persistent positivity of at least one biological criterion:
Current anticoagulant treatment, regardless of date of introduction
Exclusion Criteria:
Venous thrombotic event motivating current anticoagulant treatment favoured by a major favouring factor:
In the absence of a history of pre-eclampsia or placental insufficiency: venous thrombotic event motivating current anticoagulant treatment favoured by 2 or more minor favouring factors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Population of "non-high-risk" thrombotic APS patients treated with VKAs, regardless of how long they have been on therapy. "Non-high-risk" APS is defined by the absence of a history of arterial or microcirculatory thrombosis, the absence of valvulopathy related to APS and a biological profile with only one or two positive antiphospholipid tests.
Biological: Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml) · Behavioral: Completion of a questionnaire on compliance with anticoagulant treatment · Behavioral: Completion of a questionnaire on satisfaction with treatment anticoagulant
Population of "non-high-risk" thrombotic APS patients treated with oral AntiXa, regardless of how long they have been treated. Non-high-risk" APS is defined by the absence of a history of arterial or microcirculatory thrombosis, the absence of valvulopathy related to APS, and a biological profile with only one or two positive antiphospholipid tests.
Biological: Additional blood collection during routine blood sampling at the inclusion (33.9 ml) and at the thrombotic recurrence (between 3.5 and 5 ml) · Behavioral: Completion of a questionnaire on compliance with anticoagulant treatment · Behavioral: Completion of a questionnaire on satisfaction with treatment anticoagulant
At inclusion, the blood sample is used to perform thrombin generation tests (activated protein C resistance profile and ratio), classical and innovative aPL assays centrally to limit the fluctuation inherent in the tests used and enable comparison between patients, immunothrombosis markers: circulating neutrophil extracellular traps (NETs) assay, sTREM-1 assay In the event of recurrence, blood sampling can be used to confirm compliance with treatment by measuring the anti Xa activity of the drug or INR
The Girerd questionnaire (6 questions) will be proposed to patients in order to estimate the degree of compliance with AODs and VKAs at inclusion and at each follow-up visit for the duration of their participation in the study.
Also known as: GIRERD questionnaire
The ACTS questionnaire (15 questions) will be proposed to them in order to estimate their satisfaction with their anticoagulant treatment (AOD or AVK) at inclusion and at each follow-up visit for the duration of their participation in the study.
Also known as: Anti-Clot Treatment Scale - ACTS
Frequency of thrombotic recurrence between the 2 arms
Occurrence (percentage at group level) of thrombotic recurrence within 24 months of inclusion confirmed by objective examination and defined by the occurrence of one of the following events: * Venous thrombosis of any location or pulmonary embolism * Arterial thrombosis in any location * Microcirculatory thrombosis in any location
Time frame: "From enrollment to the thrombotic recurrence or the end of the study (24 months post-inclusion)
Risk Factors of thrombotic recurrence on the 2 arms
The risk factors for thrombotic recurrence tested were: age, gender, cardiovascular risk factors, manifestations associated with APS, associated autoimmune diseases, biological parameters (antiXa activity, INR, biomarkers of immunothrombosis collected as part of the research.
Time frame: Biological parameters : at the end of the study after the last visit of the last patient. No biological parameters : from enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)
Occurrence of major hemorrhage between the 2 arms
Major bleeding as defined by the International Society on Thrombosis and Haemostasis within Haemostasis within 24 months of inclusion
Time frame: From enrollment to the end of follow-up (24 month post-inclusion or thrombotic recurrence)
Occurrence of clinically relevant hemorrhage between the 2 arms
Occurrence of clinically relevant bleeding as defined by the International Society on Thrombosis and Haemostasis within 24 months of inclusion
Time frame: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)
Occurrence of a minor bleed between the 2 arms
Occurrence of a minor bleed within 24 months of inclusion, defined as a bleed that does not meet the International Society on Thrombosis and Haemostasis definition of clinically relevant major or non-major bleeding.
Time frame: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)
Net clinical benefit defined as a composite endpoint between the 2 arms
Net clinical benefit defined as a composite endpoint including venous, arterial or microcirculatory thrombotic recurrence, cardiovascular death or major bleeding as defined by ISTH during 24-month follow-up.
Time frame: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)
Drug Compliance evaluation between the 2 arms
Drug Compliance score assessed by Girerd test at baseline and follow-up visits. Score between 0 to 6. 0 indicates a good observance, 1 to 2 : minimal observance problem and ≥ 3 : Poor compliance
Time frame: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)
Quality of life under anticoagulants evaluation by Anti-Clot Treatment Scale (ACTS) satisfaction scores between the 2 arms
Anti-Clot Treatment Scale (ACTS) satisfaction scores measured at inclusion and at follow-up visits. The ACTS Burdens total score ranges from 12 to 60, and the ACTS Benefits total score ranges from 3 to 15. A high score for both indicates better quality of life on anticoagulants
Time frame: From enrollment to the end of follow-up (24 months post-inclusion or thrombotic recurrence)
Plan to share: No
Start is estimated for Sep 2025; primary completion for Sep 2031, 72 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France →