NCT02595346

Brief Summary

This study evaluates the benefits of hydroxychloroquine on arterial function in antiphospholipid syndrome. Briefly, the patients will be randomized in two groups, one will receive hydroxychloroquine and standard treatment, the other will receive placebo in addition of standard treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2016

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

May 17, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

November 2, 2015

Last Update Submit

April 9, 2026

Conditions

Antiphospholipid Syndrome (APS)

Outcome Measures

Primary Outcomes (1)

  • Change from baseline flow mediated dilatation of brachial artery

    The brachial artery diameter and blood flow are measured by echotracking and Doppler before and just after and ischemic test. Result expressed in percentage of diameter variation.

    6 months

Secondary Outcomes (5)

  • change from baseline in endothelial glycocalyx thickness

    6 months

  • change from baseline in oxydative stress

    6 months

  • change from baseline in systemic inflammation

    6 months

  • change from baseline in coagulation parameter

    6 months

  • change from baseline in plasmatic level in hydroxychloroquine

    6 months

Study Arms (2)

hydroxychlorquine

EXPERIMENTAL

hydroxychloroquine 200 mg twice a day for 6 months

Drug: Hydroxychloroquine

control

PLACEBO COMPARATOR

placebo 2 pills a day for 6 months

Drug: placebo

Interventions

HydroxychloroquineDRUG

endothelial function is assessed by measuring the flow mediated dilatation of humeral artery in response to ischemia. the dilatation is evaluated by echotracking. glycocalyx thickness is measured by the study of sublingual microcirculation with SDF imaging. oxydative, inflammatory and coagulation parameters is assessed on plasma samples.

Also known as: plaquenil
hydroxychlorquine
placeboDRUG

endothelial function is assessed by measuring the flow mediated dilatation of humeral artery in response to ischemia. the dilatation is evaluated by echotracking. glycocalyx thickness is measured by the study of sublingual microcirculation with SDF imaging. oxydative, inflammatory and coagulation parameters is assessed on plasma samples.

control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who fulfilled Sidney criteria for APS (antiphospholipid Syndrome
  • Women of childbearing potential must have a contraceptive method
  • Written informed consent
  • no severe, progressive, or uncontrolled kidney, liver, blood, stomach, lung, heart, or brain disease.

You may not qualify if:

  • secondary antiphospholipid syndrome
  • Pregnancy and breastfeeding
  • Patients with a history of severe depression, psychosis, or suicidal ideation
  • story of intolerance or contra-indication to hydroxychloroquine, lactose, trinitrin
  • Prior use of hydroxychloroquine in the last 6 months
  • Chronic heart failure
  • atrial fibrillation
  • severe pulmonary hypertension
  • severe kidney failure clearance \< 30ml/mn
  • uncontrolled arterial hypertension
  • secondary arterial hypertension
  • diabetes mellitus diagnosed in the last 3 months
  • body mass index \> 35
  • Patient has been committed to an institution by legal or regulatory order

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sébastien MIRANDA, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2015

First Posted

November 3, 2015

Study Start

May 17, 2016

Primary Completion

August 5, 2020

Study Completion

August 5, 2020

Last Updated

April 14, 2026

Record last verified: 2026-04

Locations

FR(1)