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Antiphospholipid SyndromeNCT07757789

Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study

A study testing Platelet count in people with Antiphospholipid Syndrome, run by New Valley University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Thrombocytopenia is common in antiphospholipid syndrome (APS) and is now included in the 2023 ACR/EULAR APS criteria as an important non criteria/hematologic feature. Persistent or low-moderate thrombocytopenia independently predicts reduced long-term survival in APS, with hazard ratios for mortality around 2.7-4.4… 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?
Platelet count
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Jul 2026to 31 Dec 2027
Phase
Interventional
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years.
  • Definite APS by Sydney criteria (thrombotic and/or obstetric) with persistent aPL positivity.
  • ≥3 documented platelet counts over ≥12 months before inclusion (to allow trajectory modeling)

Who cannot join

  • Thrombocytopenia clearly attributable to non APS causes (e.g., chemotherapy, myelodysplastic syndromes, cirrhosis, HIV).
  • Concomitant conditions strongly affecting survival independent of APS (e.g., metastatic cancer), at investigator discretion

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Asmaa N Hussein, MD contact

01065161752

asmaanady_1010@med.nvu.edu.eg

Egypt1 site, 1 recruiting

  • New Valley University

    Al Khārjah, Kharga Oasis, 72511

    Asmaa N Hussein, MD, 01065161752, asmaanady_1010@med.nvu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Thrombocytopenia Trajectories as a Dynamic Biomarker of Clinical Severity and Survival in Antiphospholipid Syndrome: A Multicenter Cohort Study

Thrombocytopenia is common in antiphospholipid syndrome (APS) and is now included in the 2023 ACR/EULAR APS criteria as an important non criteria/hematologic feature. Persistent or low-moderate thrombocytopenia independently predicts reduced long-term survival in APS, with hazard ratios for mortality around 2.7-4.4, and is associated with a severe disease phenotype and thrombotic deaths.

Read the detailed description

Thrombocytopenia also independently predicts recurrent thrombosis, pregnancy morbidity, and severe extra criteria events in primary APS, correlates with higher damage indices and thrombotic/neurological involvement, and is enriched in high-risk thrombotic APS clusters with poorer prognosis. Existing studies treat thrombocytopenia as a static exposure (present/absent, baseline level). The prognostic value of longitudinal platelet trajectories (persistent vs intermittent vs transient vs absent thrombocytopenia) for global clinical severity and survival has not been systematically evaluated.

Being tested
Platelet count
Keywords
thrombocytopenia
Medical subject headings
Antiphospholipid Syndrome, Thrombocytopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet countDiagnostic test

    Longitudinal platelet counts (routine visits, hospitalizations) will be extracted.

    • Using group based trajectory modeling or latent class mixed models, patients will be assigned to data driven platelet trajectory classes, anticipated as:
    1. Stable normal (no thrombocytopenia)
    2. Intermittent/fluctuating thrombocytopenia
    3. Persistent thrombocytopenia (less than 150×10⁹/L)
Study groups in NCT07757789
Study groupRoleWhat they receive
Antiphospholipid syndrome patientsExperimental* Definite APS by Sydney criteria (thrombotic and/or obstetric) with persistent aPL positivity. * ≥3 documented platelet counts over ≥12 months before inclusion (to allow trajectory modeling)
Receives: Diagnostic Test: Platelet count

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: From date of diagnosis until the date of death from any cause,assessed up to 5 years"

Secondary outcomes (1)

  1. number recurrent thrombotic event

    Measured: Through study completion, an average of 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2026
  2. Study start1 Jul 2026
  3. Primary completion25 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07757789
Sponsor's protocol ID
TTAPS
Status last verified
Oct 2026
First submitted
29 Jul 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chen C, Zhang A, Cheng J, Yao Z, Meng J, Qin Y, Lu Q, Li Y, Liu X, Li T, Hou C, Tang Y, Liu H, Xu N, Dong S, Li X, Xu F, Guo J, Li C. Identification of Three Distinct Subgroups in Antiphospholipid Syndrome: Implication for Sex Differences and Prognostic Outcomes from a Multicenter Study. Adv Sci (Weinh). 2025 Apr;12(15):e2415291. doi: 10.1002/advs.202415291. Epub 2025 Feb 18.

    PubMed 39965097

  • Gamal S, Mohamed S, Moghazy A. Thrombocytopenia in a cohort of primary and secondary antiphospholipid syndrome patients: Relation to clinical, laboratory manifestations and damage index. Arch Rheumatol. 2022 Jan 23;37(2):252-260. doi: 10.46497/ArchRheumatol.2022.9088. eCollection 2022 Jun.

    PubMed 36017208

  • Jin J, Xu X, Hou L, Hou Y, Li J, Liang M, Li C. Thrombocytopenia in the first trimester predicts adverse pregnancy outcomes in obstetric antiphospholipid syndrome. Front Immunol. 2022 Aug 18;13:971005. doi: 10.3389/fimmu.2022.971005. eCollection 2022.

    PubMed 36059524

  • Jin J, Zhang M, Cai X, Hou Y, Xiang X, Hou L, Li J, Li C. Severe thrombocytopenia is associated with adverse pregnancy outcomes in patients with obstetric antiphospholipid syndrome. Eur J Med Res. 2025 Jun 9;30(1):465. doi: 10.1186/s40001-025-02675-4.

    PubMed 40490817

Questions about this trial

What is this clinical trial studying?

A study testing Platelet count in people with Antiphospholipid Syndrome, run by New Valley 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 3 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 28 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 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 Asmaa N Hussein, MD (01065161752, asmaanady_1010@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: From date of diagnosis until the date of death from any cause,assessed up to 5 years"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07757789, which also lists 4 linked publications.

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 28 Oct 2026.

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