search
Back to results

Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Primary Purpose

Antiphospholipid Syndrome

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Antiphospholipid Syndrome focused on measuring antiphospholipid autoantibodies, antiphospholipid positive

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard treatment

Hydroxychloroquine

Arm Description

patients randomized to standard treatment will not receive 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.

Outcomes

Primary Outcome Measures

Number of Participants With an Acute Thrombosis Event
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

Full Information

First Posted
February 3, 2013
Last Updated
August 18, 2021
Sponsor
Hospital for Special Surgery, New York
Collaborators
AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking, The New York Community Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01784523
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
low recruitment rate exacerbated by manufacturing shortage and price increase of hydroxychloroquine.
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
Collaborators
AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking, The New York Community Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antiphospholipid Syndrome
Keywords
antiphospholipid autoantibodies, antiphospholipid positive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
patients randomized to standard treatment will not receive hydroxychloroquine.
Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
plaquenil
Primary Outcome Measure Information:
Title
Number of Participants With an Acute Thrombosis Event
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doruk Erkan, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22635205
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.
Results Reference
background
PubMed Identifier
21303838
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.
Results Reference
background
Links:
URL
http://www.apsaction.org
Description
APS ACTION

Learn more about this trial

Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

We'll reach out to this number within 24 hrs