Antiphospholipid Syndrome (APS)ReLapsNCT07178925
Follow-up Cohort of Patients With Antiphospholipid Syndrome
An observational study of Antiphospholipid Syndrome (APS), run by University Hospital, Rouen at 1 site in France.
Trial summary
Antiphospholipid syndrome (APLS) is a rare pathology characterized by the association of thrombotic (arterial, venous) or obstetric clinical manifestations and the persistent presence at least twelve weeks apart of antiphospholipid antibodies (APL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Antiphospholipid Syndrome (APS)
- What is being tested?
- Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2019to 16 Oct 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients monitored for Antiphospholipid Syndrome (APLS) in the internal medicine department
Who may be able to join
- Adult patients over 18 years of age and under 75 years of age
- Antiphospholipid syndrome meeting the 2006 Sydney classification
Who cannot join
- Patients under the age of 75 or over
- Syndrome not meeting the 2006 Sydney classification
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Antiphospholipid syndrome (APLS) is a rare pathology characterized by the association of thrombotic (arterial, venous) or obstetric clinical manifestations and the persistent presence at least twelve weeks apart of antiphospholipid antibodies (APL). It is also accompanied by accelerated atherosclerosis responsible for an increased incidence of myocardial infarction, peripheral arterial disease and stroke explaining the high cardiovascular morbidity and mortality of these patients. APS can be isolated (primary) or integrated into an autoimmune pathology such as systemic lupus erythematosus (SLE), thus defining secondary APS. Current treatment is based on anticoagulation. Currently, epidemiological data that have evaluated recurrences have estimated a rate of 5% per year. However, these studies are old and due to the significant heterogeneity of patients included in this registry, it seems that these figures are not in agreement with clinical reality.
Furthermore, several new therapeutic developments have emerged in the field of anticoagulation with the marketing of DOACs, making the EUROPHOSPHOLIPIDE data questionable. Currently, there are no clinical studies to justify the use of DOACs in this indication, but several patients have received these drugs due to intolerance or refusal of vitamin K antagonists. The other therapeutic innovation compared to the data from the EUROPHOSPHOLIPIDE cohort is the increasing use of hydroxychloroquine in clinical practice in patients with primary APS. A trial (APLAQUINE) is currently underway in our department which aims to study the endothelial protective effect of this treatment in patients with primary APS.
Read the detailed description
This trial is a retrospective and prospective cohort epidemiological study whose primary objective is to determine the rate of thrombotic recurrence in our center. Secondary objectives are to determine the risk factors associated with recurrence, assess the safety of long-term treatment in this population, and evaluate the overall morbidity and mortality of this rare disease.
A better understanding of thrombotic recurrence is essential to calculate realistic population sizes for future therapeutic trials.
- Conditions
- Antiphospholipid Syndrome (APS)
- Being tested
- Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006
- Keywords
- thrombotic recurrence rate, risk factors, treatment tolerance
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006Other
The main objective of the research is to define the thrombotic recurrence rate in our cohort of patients followed for APS in the internal medicine department, to evaluate the complication rate associated with treatment, to search for risk factors associated with thrombotic recurrence and to define the mortality and morbidity rates of this patient population.
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombotic recurrence rate
The main objective of the research is to define the thrombotic recurrence rate in our cohort of patients followed for APS in the internal medicine department.
Measured: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Secondary outcomes (4)
Complication rate
Evaluate the complication rate associated with treatment
Measured: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Risk factors associated
Look for risk factors associated with thrombotic recurrence
Measured: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Mortality rates
Evaluate the mortality rates of this patient population
Measured: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Morbidity rates
Evaluate the morbidity rates of this patient population
Measured: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start16 Oct 2019
- Primary completion16 Oct 2027 (estimated)
- Study completion16 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Syndrome (APS)Studies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178925
- Sponsor's protocol ID
- 2018/353/OB
- Other IDs
- 2018-A02845-50
- Acronym
- ReLaps
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Cohort of Patients With Antiphospholipid Syndrome
- ClinicalTrials.gov ID
- NCT07178925
- Acronym / sponsor ID
- ReLaps / 2018/353/OB
- Conditions
- Antiphospholipid Syndrome (APS)
- Keywords
- thrombotic recurrence rate, risk factors, treatment tolerance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 16 Oct 2027 (estimated)
- Study completion
- 16 Oct 2032 (estimated)
- First posted
- 17 Sep 2025 (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 (APLS) is a rare pathology characterized by the association of thrombotic (arterial, venous) or obstetric clinical manifestations and the persistent presence at least twelve weeks apart of antiphospholipid antibodies (APL). It is also accompanied by accelerated atherosclerosis responsible for an increased incidence of myocardial infarction, peripheral arterial disease and stroke explaining the high cardiovascular morbidity and mortality of these patients. APS can be isolated (primary) or integrated into an autoimmune pathology such as systemic lupus erythematosus (SLE), thus defining secondary APS. Current treatment is based on anticoagulation. Currently, epidemiological data that have evaluated recurrences have estimated a rate of 5% per year. However, these studies are old and due to the significant heterogeneity of patients included in this registry, it seems that these figures are not in agreement with clinical reality.
Furthermore, several new therapeutic developments have emerged in the field of anticoagulation with the marketing of DOACs, making the EUROPHOSPHOLIPIDE data questionable. Currently, there are no clinical studies to justify the use of DOACs in this indication, but several patients have received these drugs due to intolerance or refusal of vitamin K antagonists. The other therapeutic innovation compared to the data from the EUROPHOSPHOLIPIDE cohort is the increasing use of hydroxychloroquine in clinical practice in patients with primary APS. A trial (APLAQUINE) is currently underway in our department which aims to study the endothelial protective effect of this treatment in patients with primary APS.
Detailed description
This trial is a retrospective and prospective cohort epidemiological study whose primary objective is to determine the rate of thrombotic recurrence in our center. Secondary objectives are to determine the risk factors associated with recurrence, assess the safety of long-term treatment in this population, and evaluate the overall morbidity and mortality of this rare disease.
A better understanding of thrombotic recurrence is essential to calculate realistic population sizes for future therapeutic trials.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients monitored for Antiphospholipid Syndrome (APLS) in the internal medicine department
Key inclusion criteria (2 listed)
- Adult patients over 18 years of age and under 75 years of age
- Antiphospholipid syndrome meeting the 2006 Sydney classification
Key exclusion criteria (2 listed)
- Patients under the age of 75 or over
- Syndrome not meeting the 2006 Sydney classification
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 |
|---|---|---|
| Study of Antiphospholipid Syndrome responding to the Sydney classification of 2006The main objective of the research is to define the thrombotic recurrence rate in our cohort of patients followed for APS in the internal medicine department, to evaluate the complication rate associated with treatment, to search for risk factors associated with thrombotic recurrence and to define the mortality and morbidity rates of this patient population. | Other | – |
Primary outcome
Thrombotic recurrence rate
Time frame: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
The main objective of the research is to define the thrombotic recurrence rate in our cohort of patients followed for APS in the internal medicine department.
4 secondary outcomes
Complication rate
Time frame: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Risk factors associated
Time frame: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Mortality rates
Time frame: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Morbidity rates
Time frame: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
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 Antiphospholipid Syndrome (APS), run by University Hospital, Rouen 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sébastien SM MIRANDA, Doctor (02 32 88 90 01 ext. +33, Sebastien.Miranda@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombotic recurrence rate (time frame: Patients will be followed up in consultation every 3 months, 6 months to 1 year, for 5 years, depending on the situation. Follow-ups will not be modified compared to the usual management of the disease.). 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 27 Oct 2026.