Clinical trial NCT01784523: Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients
Official title: A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Antiphospholipid Syndrome
Keywords: antiphospholipid autoantibodies
antiphospholipid positive
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking
name: The New York Community Trust
First posted: 2013-02-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With an Acute Thrombosis Event
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Doruk Erkan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Erkan D, Lockshin MD; APS ACTION members. APS ACTION--AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking. Lupus. 2012 Jun;21(7):695-8. doi: 10.1177/0961203312437810.
citation: Erkan D, Derksen R, Levy R, Machin S, Ortel T, Pierangeli S, Roubey R, Lockshin M. Antiphospholipid Syndrome Clinical Research Task Force report. Lupus. 2011 Feb;20(2):219-24. doi: 10.1177/0961203310395053.