Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.

Conditions
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Antiphospholipid Syndrome

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment<br>patients randomized to standard treatment will not receive hydroxychloroquine. | |
| Experimental: Hydroxychloroquine<br>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. | Drug: Hydroxychloroquine<br> <br> * Other names: plaquenil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With an Acute Thrombosis Event | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antiphospholipid autoantibodies, antiphospholipid positive