Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

August 18, 2021 updated by: Hospital for Special Surgery, New York

A Prospective Randomized Controlled Trial of Hydroxychloroquine in the Primary Thrombosis Prophylaxis of aPL Positive But Thrombosis-free Patients.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

The New York Community Trust
AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking

Investigators

  • Principal Investigator: Doruk Erkan, MD, Hospital for Special Surgery, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

September 30, 2015

Study Completion (Actual)

September 30, 2015

Study Registration Dates

First Submitted

February 3, 2013

First Submitted That Met QC Criteria

February 3, 2013

First Posted (Estimate)

February 6, 2013

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

August 18, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-253

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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