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Hydroxychloroquine's effect on arteries in APS studied, but trial cut short

NCT ID NCT02595346

Disease control Sponsor: University Hospital, Rouen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether hydroxychloroquine (Plaquenil) could improve artery function in people with antiphospholipid syndrome (APS), a condition that raises the risk of blood clots. Researchers planned to give either hydroxychloroquine or a placebo to 25 participants and measure changes in blood vessel dilation. However, the trial was terminated early, so the results are limited and not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxychloroquine (also known as Plaquenil)
What this could lead to
If it worked, this could point toward a way to improve blood vessel health and reduce clotting risk in people with antiphospholipid syndrome.
What could go wrong
The trial was terminated early and very small (25 people), so results are limited. Hydroxychloroquine can cause side effects like vision problems or heart issues in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

May 2016

Finished

Aug 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antiphospholipid syndrome (APS)

Contacts and locations

Locations

  • Rouen University Hospital

    Rouen, 76031, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.