Primary Antiphospholipid Syndrome Clinical Trial
Official title:
Hydroxychloroquine Versus Placebo: Impact on Thrombotic Relapse in Primary Antiphospholipid Syndrome
Antiphospholipid syndrome (APS) combines thrombotic (venous and/or arterial) and/or
obstetrical manifestations, along with biological anomalies related to the presence of
antiphospholipid antibodies. Despite actual treatment recommended by international
guidelines, the relapse rate in APS is high and survival is 65% at 15 years.
Hydroxychloroquine has demonstrated its efficacy and benefits in the treatment of Systemic
Lupus Erythematosus, but there is no current consensus concerning the efficacy of this
treatment in the secondary prevention of thrombotic events in primary APS, even though
several in vitro experimental and animal model data, along with several clinical studies have
suggested a beneficial effect of this drug in this indication. Considering the prevalence of
primary APS in the general population and of the number of clinical events observed in
patients with primary APS and receiving conventional treatment with vitamin K anticoagulants
(VKA), the consortium expects a minimum clinically relevant difference of 70%. Considering a
prevalence of thrombotic events for the entire studied primary APS population of 10% at 2
years, the consortium expects a 70% decrease in thrombotic events under Hydroxychloroquine
treatment administered in addition to VKA treatment in primary APS, i.e. a 3% prevalence in
the Hydroxychloroquine group at 2 years. The consortium proposes a drug trial, phase III,
national multicentric, comparative, randomized, superiority, double-blind, controlled with 2
compared groups (Hydroxychloroquine versus placebo) study. The enrolment period will be 24
months.
The main aim of this trial is to comparatively assess at 24 months the number of new
thrombotic events (venous and arterial) in primary antiphospholipid syndrome in patients
treated with VKA plus Hydroxychloroquine versus VKA plus placebo, in a multicentre,
prospective randomized, double-blind, versus placebo study.
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