Antiphospholipid SyndromeNCT06808607
Clinical Outcomes of Primary Versus Secondary Antiphospholipid Syndrome
An observational study of Antiphospholipid Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
Observational retrospective cohort study to assess clinical outcomes in patients with primary versus secondary antiphospholipid syndrome Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Antiphospholipid Syndrome
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Feb 2025to 6 Mar 2026
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Retrospective cohort
Who may be able to join
- All patients diagnosed as antiphospholipid syndrome in clinical hematology or rheumatology units in internal medicine department, Assiut university hospital.
Who cannot join
- patients with other risk factor for thrombosis (malignancy, cocs, protein c or protein s deficiency etc
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Maha Abdel-Aziz
Asyut, 71515
Maha Abdel-Aziz, Clinical and MD, 2001097278659, maha.hematology@aun.edu.eg
Yomna Refaat, Clinical Hematology MD, yomnarefaat@aun.edu.eg
About this study
Official title: Thrombotic Outcome of Primary Versus Secondary Antiphospholipid Syndrome
Observational retrospective cohort study to assess clinical outcomes in patients with primary versus secondary antiphospholipid syndrome
Read the detailed description
Antiphospholipid antibody syndrome is an autoimmune disorder associated with positive antiphospholipid antibodies including the lupus anticoagulant, anticardiolipin antibodies IgG or IgM, and/or anti-ß2-glycoprotein IgG or IgM associated with thrombotic problems and pregnancy loss.
Antiphospholipid syndrome is one of the most frequent forms of acquired thrombophilia and is associated with an increased risk of both venous and arterial thrombotic events. Thirty to 40% of systemic lupus erythematosus (SLE) patients have associated antiphospholipid syndrome.
Antiphospholipid syndrome has estimated incidence in the general population of 2.1 (1.4-2.8) per 100 000, and the prevalence of 50 (42-58) per 100 000. APS is more common in female with a female to male ratio is 3.5:1 for primary and 7:1 for secondary.
Antiphospholipid syndrome is divided into two types primary syndrome without an underlying disease, and secondary antiphospholipid syndrome that is associated with another autoimmune syndrome, most commonly Systemic Lupus Erythematosus (SLE).
Patients with APS are more at risk of recurrent thrombosis (3). n a retrospective analysis of 160 patients with APS, venous thromboembolism (VTE) was found to be the commonest manifestation (47.5%) followed by arterial thromboembolism (43.1%) then materno fetal problems which were found only in 9.7% of patients, and finally, catastrophic antiphospholipid syndrome (CAPS) represented in only 2.5 percent of the cases (4).
The clinical manifestations of antiphospholipid syndrome include haematological (thrombocytopenia, venous thrombosis), obstetrical (recurrent pregnancy loss), neurological (stroke, transient ischaemic attack, seizures), cardiovascular, dermatological such as livedo reticularis, skin ulceration and necrosis, renal (glomerulonephritis and renal thrombotic microangiopathy), and orthopedic (avascular necrosis of bones).
the manifestation spectrum ranged from asymptomatic antiphospholipid antibodies positivity, various non-criteria manifestations, obstetric morbidity, thrombosis, to life-threatening catastrophic antiphospholipid syndrome. The wide manifestation spectrum led to a heterogeneous entity and brought challenges to management of the syndrome.
The aim of this study was to compare primary versus secondary effects of antiphospholipid syndrome on the development of thrombosis and its outcomes.
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Thrombosis, Antiphospholipid syndrome
- Medical subject headings
- Antiphospholipid Syndrome, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective to compare clinical outcomes of primary versus secondary antiphospholipi | Observational study to compare clinical outcomes of primary versus secondary antiphospholipid syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare percentage of patients with primary versus secondary antiphospholipid syndrome in developing recurrent thrombosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start7 Feb 2025 (estimated)
- Primary completion6 Mar 2026 (estimated)
- Study completion6 Mar 2026 (estimated)
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 Assiut UniversityThe 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
- Retrospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mohammed Abdel-Aziz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808607
- Sponsor's protocol ID
- 04-2024-300543
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2025
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided yet
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombotic Outcome of Primary Versus Secondary Antiphospholipid Syndrome
- ClinicalTrials.gov ID
- NCT06808607
- Acronym / sponsor ID
- 04-2024-300543
- Conditions
- Antiphospholipid Syndrome
- Keywords
- Thrombosis, Antiphospholipid syndrome
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Feb 2025 (estimated)
- Primary completion
- 6 Mar 2026 (estimated)
- Study completion
- 6 Mar 2026 (estimated)
- First posted
- 5 Feb 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.
Observational retrospective cohort study to assess clinical outcomes in patients with primary versus secondary antiphospholipid syndrome
Detailed description
Antiphospholipid antibody syndrome is an autoimmune disorder associated with positive antiphospholipid antibodies including the lupus anticoagulant, anticardiolipin antibodies IgG or IgM, and/or anti-ß2-glycoprotein IgG or IgM associated with thrombotic problems and pregnancy loss.
Antiphospholipid syndrome is one of the most frequent forms of acquired thrombophilia and is associated with an increased risk of both venous and arterial thrombotic events. Thirty to 40% of systemic lupus erythematosus (SLE) patients have associated antiphospholipid syndrome.
Antiphospholipid syndrome has estimated incidence in the general population of 2.1 (1.4-2.8) per 100 000, and the prevalence of 50 (42-58) per 100 000. APS is more common in female with a female to male ratio is 3.5:1 for primary and 7:1 for secondary.
Antiphospholipid syndrome is divided into two types primary syndrome without an underlying disease, and secondary antiphospholipid syndrome that is associated with another autoimmune syndrome, most commonly Systemic Lupus Erythematosus (SLE).
Patients with APS are more at risk of recurrent thrombosis (3). n a retrospective analysis of 160 patients with APS, venous thromboembolism (VTE) was found to be the commonest manifestation (47.5%) followed by arterial thromboembolism (43.1%) then materno fetal problems which were found only in 9.7% of patients, and finally, catastrophic antiphospholipid syndrome (CAPS) represented in only 2.5 percent of the cases (4).
The clinical manifestations of antiphospholipid syndrome include haematological (thrombocytopenia, venous thrombosis), obstetrical (recurrent pregnancy loss), neurological (stroke, transient ischaemic attack, seizures), cardiovascular, dermatological such as livedo reticularis, skin ulceration and necrosis, renal (glomerulonephritis and renal thrombotic microangiopathy), and orthopedic (avascular necrosis of bones).
the manifestation spectrum ranged from asymptomatic antiphospholipid antibodies positivity, various non-criteria manifestations, obstetric morbidity, thrombosis, to life-threatening catastrophic antiphospholipid syndrome. The wide manifestation spectrum led to a heterogeneous entity and brought challenges to management of the syndrome.
The aim of this study was to compare primary versus secondary effects of antiphospholipid syndrome on the development of thrombosis and its outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective to compare clinical outcomes of primary versus secondary antiphospholipi | – | –Observational study to compare clinical outcomes of primary versus secondary antiphospholipid syndrome |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Retrospective cohort
Key inclusion criteria (1 listed)
- All patients diagnosed as antiphospholipid syndrome in clinical hematology or rheumatology units in internal medicine department, Assiut university hospital.
Key exclusion criteria (1 listed)
- patients with other risk factor for thrombosis (malignancy, cocs, protein c or protein s deficiency etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
to compare percentage of patients with primary versus secondary antiphospholipid syndrome in developing recurrent thrombosis
Time frame: 12 months
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 5 Feb 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided yet
Related trials for Antiphospholipid Syndrome
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Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study
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Follow-up Cohort of Patients With Antiphospholipid Syndrome
Antiphospholipid Syndrome (APS)
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MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)
Antiphospholipid (aPL)-Positive, Rheumatic Arthritis
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An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease
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RecruitingPhase 1
A Clinical Study of YTS109 Cells for the Treatment of R/R Autoimmune Diseases
Systemic Lupus Erythematosus (SLE), Lupus Nephritis (LN)
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, run by Assiut University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 5 Feb 2025. 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 Egypt. 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 Maha Abdel-Aziz, Clinical Hematology MD (2001097278659, maha.hematology@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare percentage of patients with primary versus secondary antiphospholipid syndrome in developing recurrent thrombosis (time frame: 12 months). 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 5 Feb 2025.