Conditions: Antiphospholipid Syndrome
Keywords: antiphospholipid autoantibodies antiphospholipid positive
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
In this multi-center international study, our aim is to determine the effectiveness of HCQ for primary thrombosis prophylaxis in persistently aPL-positive but thrombosis-free patients without systemic autoimmune diseases.

Detailed description:
Randomized to receive HCQ or no treatment in addition to their standard regimen. 11 study visits and 10 phone visits over 5 years.

This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.

Arms:
arm 1: patients randomized to standard treatment will not receive hydroxychloroquine. arm 2: Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing \<60kg; and 400 mg daily (200 mg twice a day)for patients weighing \>60kg.

Interventions: intervention 1: Hydroxychloroquine
Intervention descriptions: intervention 1: None

Protocol document: