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 range
18 Years – 60 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With an Acute Thrombosis Event