Thrombocytopenia Trajectories in Antiphospholipid Syndrome: A Multicenter Cohort Study

ConditionAntiphospholipid Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNew Valley University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

Platelet count
Diagnostic 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)

Treatment groups

200 Participants

are divided into 1 treatment group

Group A: Antiphospholipid syndrome patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

All-cause mortality

Time frame

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

Secondary outcomes

number recurrent thrombotic event

Time frame

Through study completion, an average of 5 years.

Sponsors and contacts

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New Valley University

Lead sponsor

Source ClinicalTrials.gov

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