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Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01784523
Recruitment Status : Terminated (low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.)
First Posted : February 6, 2013
Last Update Posted : November 30, 2017
Sponsor:
Collaborators:
APS ACTION
NY Community Trust Fund
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Antiphospholipid Syndrome Drug: Hydroxychloroquine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.
Study Start Date : February 2013
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : September 30, 2015


Arm Intervention/treatment
No Intervention: Standard treatment
patients randomized to standard treatment will not receive hydroxychloroquine.
Experimental: Hydroxychloroquine
Patients will be randomized to receive standard of care or standard of care + hydroxychloroquine. Dose will be weight-adjusted: 200 mg daily for patients weighing <60kg; and 400 mg daily (200 mg twice a day)for patients weighing >60kg.
Drug: Hydroxychloroquine
Other Name: plaquenil




Primary Outcome Measures :
  1. Incident acute thrombosis [ Time Frame: 5 years ]
    To determine the efficacy of Hydroxychloroquine in the primary thrombosis prevention of persistently aPL-positive but thrombosis free patients with no other systemic autoimmune diseases over the five year study period.


Secondary Outcome Measures :
  1. thrombosis incidence rate [ Time Frame: 5 years ]

    In persistently aPL-positive patients with no other systemic autoimmune diseases, to determine:

    1. The thrombosis incidence rate
    2. The effect of Hydroxychloroquine on mortality rate
    3. The effect of Hydroxychloroquine on aPL profile



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784523


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
APS ACTION
NY Community Trust Fund
Investigators
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Principal Investigator: Doruk Erkan, MD Hospital for Special Surgery, New York
Additional Information:
Publications:
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01784523    
Obsolete Identifiers: NCT02635126
Other Study ID Numbers: 2014-253
First Posted: February 6, 2013    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Keywords provided by Hospital for Special Surgery, New York:
antiphospholipid autoantibodies
antiphospholipid positive
Additional relevant MeSH terms:
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Thrombosis
Antiphospholipid Syndrome
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents