Title
Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
Phase
Phase 3Lead Sponsor
Rockefeller UniversityStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
Antiphospholipid SyndromeIntervention/Treatment
hydroxychloroquine ...Study Participants
11In 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.
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.
patients randomized to standard treatment will not receive 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.
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
| Event Type | Organ System | Event Term |
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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.
