NCT07757789

Brief 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, and is associated with a severe disease phenotype and thrombotic deaths.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
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 Progress8%
Jul 2026Dec 2027

Study Start

First participant enrolled

July 1, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

1.2 years

First QC Date

July 29, 2026

Last Update Submit

August 5, 2026

Conditions

Antiphospholipid Syndrome

Keywords

thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

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

Secondary Outcomes (1)

  • number recurrent thrombotic event

    Through study completion, an average of 5 years.

Study Arms (1)

Antiphospholipid syndrome patients

EXPERIMENTAL

* 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)

Diagnostic Test: Platelet count

Interventions

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. Transient thrombocytopenia (recovery to normal) 3. Intermittent/fluctuating thrombocytopenia 4. Persistent mild-moderate thrombocytopenia (e.g., 50-149×10⁹/L) 5. Persistent severe thrombocytopenia (\<50×10⁹/L)

Antiphospholipid syndrome patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Definite APS by Sydney criteria (thrombotic and/or obstetric) with persistent aPL positivity.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Valley University

Al Khārjah, Kharga Oasis, 72511, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 39965097BACKGROUND

  • 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.

    PMID: 36017208BACKGROUND

  • 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.

    PMID: 36059524BACKGROUND

  • 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.

    PMID: 40490817BACKGROUND

MeSH Terms

Conditions

Antiphospholipid SyndromeThrombocytopenia

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System DiseasesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Intervention Hierarchy (Ancestors)

Blood Cell CountCell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsPlatelet Function TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Asmaa N Hussein, MD

CONTACT

01065161752asmaanady_1010@med.nvu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Internal Medicine

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 11, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

September 25, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)