NCT07142239

Brief Summary

Antiphospholipid syndrome is a thrombo-inflammatory autoimmune disorder with a complex antiphospholipid antibody-mediated pathogenesis, and high heterogeneity in clinical presentation and disease course. Clinical presentation in antiphospholipid syndrome includes venous and arterial thrombosis, pregnancy complications, and a broad range of microvascular and non-thrombotic manifestations

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Nov 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Nov 2025Jun 2027

First Submitted

Initial submission to the registry

August 19, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

November 27, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

August 19, 2025

Last Update Submit

August 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • compare the levels and clinical implications of hematological markers mean platelet volume (MPV), platelet-to-lymphocyte ratio (PLR), and neutrophil-to-lymphocyte ratio (NLR) between patients diagnosed with primary APS and those with secondary APS

    comparison

    once

Study Arms (2)

1

Primary APS

Diagnostic Test: • Complete blood count , MPVDiagnostic Test: Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:Diagnostic Test: Antiphospholipid antibody profile

2

secondary APS

Diagnostic Test: • Complete blood count , MPVDiagnostic Test: Calculation of PLR: Platelet count / Lymphocyte count and Calculation of NLR:Diagnostic Test: Antiphospholipid antibody profile

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will be categorized as: Primary APS: APS without other systemic autoimmune diseases Secondary APS: APS associated with autoimmune diseases such as systemic lupus erythematosus (SLE)

You may qualify if:

  • Adults (age ≥18 years)
  • Diagnosis of APS based on updated Sydney classification criteria confirmed by: Clinical history of thrombosis and/or pregnancy morbidity, Persistent presence (≥12 weeks) of antiphospholipid antibodies (aCL, anti-β2-glycoprotein I, and/or lupus anticoagulant)

You may not qualify if:

  • Current infection or inflammatory condition unrelated to APS
  • Hematological malignancies or other blood disorders
  • Recent blood transfusion or platelet-altering medications other than APS treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Cervera R, Serrano R, Pons-Estel GJ, Ceberio-Hualde L, Shoenfeld Y, de Ramon E, Buonaiuto V, Jacobsen S, Zeher MM, Tarr T, Tincani A, Taglietti M, Theodossiades G, Nomikou E, Galeazzi M, Bellisai F, Meroni PL, Derksen RH, de Groot PG, Baleva M, Mosca M, Bombardieri S, Houssiau F, Gris JC, Quere I, Hachulla E, Vasconcelos C, Fernandez-Nebro A, Haro M, Amoura Z, Miyara M, Tektonidou M, Espinosa G, Bertolaccini ML, Khamashta MA; Euro-Phospholipid Project Group (European Forum on Antiphospholipid Antibodies). Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients. Ann Rheum Dis. 2015 Jun;74(6):1011-8. doi: 10.1136/annrheumdis-2013-204838. Epub 2014 Jan 24.

    PMID: 24464962BACKGROUND
  • Shi Y, Zhao J, Jiang H, Huang C, Qi W, Song Y, Wang Q, Li M, Tian X, Zhao Y, Zeng X. Thrombocytopenia in primary antiphospholipid syndrome: association with prognosis and clinical implications. Rheumatology (Oxford). 2022 Dec 23;62(1):256-263. doi: 10.1093/rheumatology/keac264.

    PMID: 35536236BACKGROUND
  • Garcia-Escobar A, Vera-Vera S, Tebar-Marquez D, Rivero-Santana B, Jurado-Roman A, Jimenez-Valero S, Galeote G, Cabrera JA, Moreno R. Neutrophil-to-lymphocyte ratio an inflammatory biomarker, and prognostic marker in heart failure, cardiovascular disease and chronic inflammatory diseases: New insights for a potential predictor of anti-cytokine therapy responsiveness. Microvasc Res. 2023 Nov;150:104598. doi: 10.1016/j.mvr.2023.104598. Epub 2023 Aug 24.

    PMID: 37633337BACKGROUND
  • Farah R, Nseir W, Kagansky D, Khamisy-Farah R. The role of neutrophil-lymphocyte ratio, and mean platelet volume in detecting patients with acute venous thromboembolism. J Clin Lab Anal. 2020 Jan;34(1):e23010. doi: 10.1002/jcla.23010. Epub 2019 Sep 11.

    PMID: 31508844BACKGROUND
  • Lattanzi S, Norata D, Broggi S, Meletti S, Switonska M, Slomka A, Silvestrini M. Neutrophil-to-Lymphocyte Ratio Predicts Early Neurological Deterioration after Endovascular Treatment in Patients with Ischemic Stroke. Life (Basel). 2022 Sep 10;12(9):1415. doi: 10.3390/life12091415.

    PMID: 36143451BACKGROUND
  • Morkavuk SB, Kocaoz S, Korukluoglu B. Diagnostic value of Platelet/lymphocyte Ratio (PLR) for predicting sentinel axillary lymph node positivity in early-stage breast cancer compared with ultrasonography. Int J Clin Pract. 2021 Dec;75(12):e14939. doi: 10.1111/ijcp.14939. Epub 2021 Oct 12.

    PMID: 34605138BACKGROUND

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Blood Cell CountMean Platelet VolumeLymphocyte Count

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaPlatelet Function TestsCell SizeLeukocyte Count

Central Study Contacts

Asmaa Nady Hussein, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

August 19, 2025

First Posted

August 26, 2025

Study Start

November 27, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share