Hydroxychloroquine for the First Thrombosis Prevention in Antiphospholipid Antibody Positive Patients

Antiphospholipid Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01784523
• Other study ID #: 2014-253
• Status: Terminated
• Phase: Phase 3
• Start date: February 2013
• Est. completion date: September 30, 2015

Study information

• Verified date: August 2021
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT02635126

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: September 30, 2015
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

• aß2GPI 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

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Thrombosis

Intervention

Drug:
• Hydroxychloroquine

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	AntiPhospholipid Syndrome Alliance For Clinical Trials and InternatiOnal Networking, The New York Community Trust

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years

External Links

•   APS ACTION