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New global registry tracks safety of common blood thinners in APS patients

NCT ID NCT04262492

Knowledge-focused Sponsor: Stéphane Zuily Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is creating a global registry of 500 adults with antiphospholipid syndrome (APS) who are taking direct oral anticoagulants (DOACs) like rivaroxaban or apixaban. Researchers will track rates of recurrent blood clots and bleeding over at least 6 months. The goal is to gather real-world safety information for this specific patient group.

What this could mean

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

Active substance
Direct oral anticoagulants (rivaroxaban, dabigatran, apixaban, edoxaban)
What this could lead to
If successful, this registry could provide clearer safety data on using DOACs in low-risk APS patients, potentially guiding future treatment decisions.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may be limited by patient selection and real-world variability.

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.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Apr 2031

An estimate. End dates often move.

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.

Who is studied

Thrombotic APS patients according to revised Sapporo-Sydney criteria

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

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: * Patient receiving a comprehensive information about the study, and not opposed to participate * Age ≥ 18 yo * Classification of definite APS according to revised Sapporo-Sydney criteria * Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months Exclusion Criteria: * Incomplete revised Sapporo-Sydney criteria * No data regarding the recurrent thrombosis * Pregnant woman * Age \< 18 yo

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Conditions

The condition(s) this trial relates to.

antiphospholipid syndrome thrombotic disease

As listed by the trial registrant

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

Anticoagulants causing adverse effects in therapeutic use Antiphospholipid syndrome Thrombosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stéphane Zuily

    RECRUITING

    Nancy, 54500, France

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