Negative Antiphospholipid Syndrome: a Multicentric Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorItalian Society for Rheumatology
About this trial
Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.
The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.
Eligibility criteria
Qualifiers
Group 1 [APS]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)
Group 2 [SN-APS]: patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases)
Group 3: patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases).
Age < 65 years (at event time)
Disqualifiers
Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations
Deceased patients
Less than 5 years from the first event
Trial design
Treatments tested in this trial
- Diagnostic accuracy
Treatment groups
105 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov