Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Pati… (NCT01784523) | Clinical Trial Compass
TerminatedPhase 3
Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
Stopped: low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
United States11 participantsStarted 2013-02
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of Participants With an Acute Thrombosis Event