Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Phase 3

Terminated

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.

Recruitment & Eligibility

Inclusion Criteria

Persistent(at least 12 weeks apart)aPL-positivity within 12 months prior to the screening defined as:
- aCL IgG/M (>40U,medium-to-high titer,and/or greater than the 99th percentile)and/or
- aβ2GPI IgG/M(>40U, medium-to-high titer, and/or greater than the 99th percentile)and/or
- Positive LA test based on the International Society of Thrombosis & Haematosis Recommendations

Selected

Exclusion Criteria

History of thrombosis (arterial, venous, and/or biopsy proven microthrombosis
History of Transient Ischemic Attack Confirmed by a Neurologist
SLE Diagnosis based on the ACR Classification Criteria > 4/11
Other Systemic Autoimmune Diseases diagnosed based on ACR Classification Criteria
Current Hydroxychloroquine or another antimalarial treatment (-3 months)
Current warfarin treatment (-3 months)
Current heparin therapy( -3 months)
Current pregnancy
History of Hydroxychloroquine eye toxicity
History of Hydroxychloroquine allergy
Known glucose-6-phosphate dehydrogenase deficiency

Arm && Interventions

Group	Intervention	Description
Hydroxychloroquine	Hydroxychloroquine	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Acute Thrombosis Event	2 years	To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.

Secondary Outcome Measures