Research

A Prospective, Randomized-Controlled Trial Comparing Hydroxychloroquine in the Primary Thrombosis Prophylaxis of Persistently Antiphospholipid Antibody (aPL) Positive but Thrombosis-free Patients without Systemic Autoimmune Diseases.

IRB Number: 11179

Institutional Review Board, Hospital for Special Surgery

January 31, 2014

The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.

Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.

For further information, see Understanding Clinical Trials.

Principal Investigator

Doruk Erkan, M.D.

Co-Investigators

Michael D. Lockshin, M.D.

Summary

Based on the randomization, patients will be assigned to receive Hydroxychloroquine or no
treatment in addition to their standard regimen. The study duration is 5 years. Patients will be
followed every 6 months (unless they develop new thrombosis or pregnancy morbidity) for a
total of five years. Extensive clinical data collection will be performed once a year (unless they
develop new thrombosis and/or pregnancy morbidity). Patients will receive phone calls (month
3-9-15-21-27-33-39-45-51-57) to monitor new blood clots.

Inclusion/Exclusion Criteria

Inclusion Criteria: 
 Age 18-60
 Persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to the screening defined as:
o aCL IgG/M (> 40U, medium-to-high titer, and/or greater than the 99th percentile) and/or
o aB2GPI IgG/M (>40U, medium-to-high titer, and/or greater than the 99th percentile) and/or
o Lupus Anticoagulant test positive based on the International Society of Thrombosis & Haematosis Recommendations 

Selected Exclusion Criteria
You cannot take part in this study if you have:
 History of blood clots
 History of Transient Ischemic Attack
 Lupus diagnosis
 Other Systemic Autoimmune Diseases diagnosis (e.g., Rheumatoid Arthritis, Systemic Vasculitis, Spondylarthropathy, Systemic Sclerosis, Inflammatory Muscle Disease, Sjogren Syndrome)
 Received Hydroxychloroquine within the last 3 months
 Received Warfarin (Coumadin) within the last 3 months
 Received Heparin within the last 3 months
 Current pregnancy
 Acute seizure within 7 days prior to screening
 Psoriasis
 History of Hydroxychloroquine eye toxicity
 History of Hydroxychloroquine allergy
 Known Glucose-6-phosphate dehydrogenase deficiency
 Known malignancy (with the exception of non-metastatic squamous cell and basal cell skin carcinomas)

Contact Information

JoAnn Vega
 vegaj@hss.edu
 212.774.2795



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