HYDROxychloroquine in Syndrome Primary AntiPhospholipid
Status:
Not yet recruiting
Trial end date:
2025-10-02
Target enrollment:
Participant gender:
Summary
Antiphospholipid syndrome (APS) is defined by thrombosis or obstetric complication (≥ 3
spontaneous miscarriages or fetal death or prematurity <34 weeks gestation-related amenorrhea
(SA)) associated with antiphospholipid antibodies. The rate of term pregnancies has been
improved by conventional treatment (aspirin 100 mg / day with low molecular weight heparin
(LMWH) in an isocoagulant dose) to almost 75%. In the PROMISSE study, when considering
progressive pregnancies after 20 weeks, 19% of pregnancies presented at least one
complication despite the treatment (maternal, fetal or neonatal complications) related to
APS. In the European APS register, maternal complications and IUGR were observed in 13% of
cases, and prematurity in approximately 14% of cases despite treatment. In a previous study
of 72 pregnancies during a LAS, we observed, under aspirin and LMWH, 25% of fetal losses, and
10% of at least one maternal and / or fetal complication or prematurity. The presence of
lupus, a history of thrombosis, a circulating anticoagulant (ACC) and a triple positivity of
antiphospholipids are considered to be factors associated with a poor obstetrical prognosis.
Hydroxychloroquine (HCQ) has anti-inflammatory and anti-thrombotic properties. In vitro
studies have shown that HCQ is able to restore the expression of placental annexin V, which
has an anticoagulant effect and prevent the attachment of antiphospholipid antibodies to the
placenta.
HCQ during lupus decreases the thrombotic risk and its usefulness during thrombotic APS has
been shown in a French series. In a European study, the addition of the HCQ to conventional
treatment improved term pregnancies by 70% in the event of refractory APS. Its use during
pregnancies of patients with lupus, the numerous data on tolerance during pregnancy and the
follow-up of children born to mothers exposed to the HCQ demonstrates a reassuring tolerance
profile for the mother and the fetus.
The objective of this clinical trial is to evaluate the benefit of addition or no of
hydroxychloroquine to conventional treatment in obstetric APS.