Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology, Endocrine |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/2/2017 |
| Start Date: | February 2013 |
| End Date: | September 30, 2015 |
A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
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.
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.
visits and 10 phone visits over 5 years.
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
We found this trial at
1
site
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
Click here to add this to my saved trials
