Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Results First Posted : May 4, 2021
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking
The New York Community Trust
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

This study was terminated at 2 years due to low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of Participants With an Acute Thrombosis Event [ Time Frame: 2 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking
The New York Community Trust
Investigators
Layout table for investigator information
Principal Investigator: Doruk Erkan, MD Hospital for Special Surgery, New York
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
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
Results First Posted: May 4, 2021
Last Update Posted: September 14, 2021
Last Verified: August 2021
Keywords provided by Hospital for Special Surgery, New York:
antiphospholipid autoantibodies
antiphospholipid positive
Additional relevant MeSH terms:
Layout table for MeSH terms
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