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Blood thinners may be unnecessary for minor lung clots, new trial suggests

NCT ID NCT04263038

Disease control Sponsor: Drahomir Aujesky 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two approaches for low-risk patients with small blood clots in the lungs (isolated subsegmental pulmonary embolism). Half will receive standard blood-thinning medication (rivaroxaban), while the other half will get a placebo and be closely monitored. The goal is to see if simply watching and waiting is as safe as taking blood thinners, which can cause serious bleeding. The trial involves 276 adults and will track recurrent clots, bleeding events, and deaths.

What this could mean

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

Active substance
Rivaroxaban (blood thinner) or placebo (inactive pill)
What this could lead to
If successful, this could show that many patients with tiny lung clots can safely skip blood thinners, avoiding unnecessary bleeding risks.
What could go wrong
This is a relatively small Phase 4 trial (276 people), and the results may not apply to higher-risk patients. There is a chance that skipping blood thinners could lead to more clots.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 276 people

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

Started

May 2020

Expected to finish

May 2028

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.

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: 1. Informed Consent as documented by signature 2. Age ≥18 years 3. Objective diagnosis of symptomatic or asymptomatic isolated SSPE Exclusion Criteria: 1. Presence of leg deep vein thrombosis (DVT) or upper extremity DVT (subclavian vein or above) 2. Active cancer, defined as cancer treated with surgery, chemotherapy, radiotherapy, or palliative care during the last 6 months 3. ≥1 prior episode of unprovoked VTE (absence of a transient or permanent risk factor) 4. Clinical instability (systolic blood pressure \<100 mm Hg or arterial Oxygen saturation \<92% at ambient air) at the time of presentation 5. Active bleeding or at high risk of bleeding 6. Severe renal failure (creatinine clearance \<30ml/min) 7. Severe liver insufficiency (Child-Pugh B or C) 8. Concomitant use of strong CYP3A4 inhibitors or strong CYP3A4 inducers 9. Known hypersensitivity to rivaroxaban 10. Need for therapeutic anticoagulation for another reason 11. Therapeutic anticoagulation for \>72 hours for any reason at the time of screening 12. Hospitalized for \>72 hours prior to the diagnosis of isolated SSP (hospital-acquired VTE) 13. Known pregnancy or breast feeding (pregnancy test to be performed for women of childbearing potential) 14. Lack of safe contraception in women of childbearing potential 15. Refusal or inability to provide informed consent 16. Prior enrolment in this trial

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Embolism Embolism and Thrombosis Hemorrhage hemorrhagic disease lung disorder pulmonary embolism respiratory system disorder venous thromboembolism

As listed by the trial registrant

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

Anticoagulant-induced bleeding Bleeding Cardiovascular diseases Embolism Embolism and thrombosis Lung diseases Pulmonary embolism Respiratory tract diseases Venous thromboembolism

How to take part

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

  1. The places running it

    29 sites in 5 countries. 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

  • Albert Schweitzer Ziekenhuis Dordrecht

    RECRUITING

    Dordrecht, Netherlands

  • CHU De Rouen

    RECRUITING

    Rouen, France

  • CHU Gabriel-Montpied

    RECRUITING

    Clermont-Ferrand, France

  • CHU ST Etienne - Hôpital Nord

    RECRUITING

    Saint-Priest-en-Jarez, France

  • Cantonal Hospital of Aarau

    RECRUITING

    Aarau, Canton of Aargau, Switzerland

  • Cantonal Hospital of Baden

    RECRUITING

    Baden, Switzerland

  • Cantonal Hospital of Frauenfeld

    RECRUITING

    Frauenfeld, Thurgau, Switzerland

  • Cantonal Hospital of Fribourg

    WITHDRAWN

    Fribourg, Canton of Fribourg, Switzerland

  • Cantonal Hospital of Liestal

    RECRUITING

    Liestal, Basel, Switzerland

  • Cantonal Hospital of Lucerne

    WITHDRAWN

    Lucerne, Canton of Lucerne, Switzerland

  • Cantonal Hospital of Olten

    WITHDRAWN

    Olten, Canton of Solothurn, Switzerland

  • Cantonal Hospital of St. Gallen

    RECRUITING

    Sankt Gallen, Canton of St. Gallen, Switzerland

  • Cantonal Hospital of Uri

    WITHDRAWN

    Altdorf, Switzerland

  • Cantonal Hospital of Winterthur

    RECRUITING

    Winterthur, Canton of Zurich, Switzerland

  • Centre Hospitalier Regional Et Universitaire De Brest

    RECRUITING

    Brest, France

  • Centre Hospitalier Universitaire De Dijon

    RECRUITING

    Dijon, France

  • Centre hospitalier universitaire de Liege

    RECRUITING

    Liège, Belgium

  • Cliniques Universitaires Saint-Luc

    RECRUITING

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

  • Erasmus Universitair Medisch Centrum

    WITHDRAWN

    Rotterdam, Netherlands

  • Geneva University Hospital

    RECRUITING

    Geneva, Switzerland

  • Haaglanden Medisch Centrum

    WITHDRAWN

    The Hague, Netherlands

  • Hospital Edouard Herriot

    RECRUITING

    Lyon, France

  • Hospital of Bienne

    RECRUITING

    Biel/Bienne, Canton of Bern, Switzerland

  • Hospital of Delémont

    TERMINATED

    Delémont, Switzerland

  • Hospital of Neuchâtel

    RECRUITING

    Neuchâtel, Switzerland

  • Hospital of Nyon

    WITHDRAWN

    Nyon, Canton of Vaud, Switzerland

  • Hospital of Sion

    WITHDRAWN

    Sion, Valais, Switzerland

  • Hôpital Bicêtre - APHP

    RECRUITING

    Le Kremlin-Bicêtre, Le Kremlin-Bicêtre, 94270, France

  • Hôpitaux universitaires de Marseille Timone AP-HM

    RECRUITING

    Marseille, France

  • Isala Klinieken Zwolle

    RECRUITING

    Zwolle, Netherlands

  • Leiden University Medical Center

    RECRUITING

    Leiden, Netherlands

  • Medisch Spectrum Twente

    RECRUITING

    Enschede, Netherlands

  • Regional Hospital of Emmental

    RECRUITING

    Burgdorf, Switzerland

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Canada

  • Tiefenau Hospital

    COMPLETED

    Bern, Switzerland

  • Triemli Hospital

    RECRUITING

    Zurich, Canton of Zurich, Switzerland

  • University Hospital Inselspital

    RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

  • University Hospital Zürich

    WITHDRAWN

    Zurich, Canton of Zurich, Switzerland

  • University Hospital of Basel

    RECRUITING

    Basel, Switzerland

  • University Hospital of Lausanne

    RECRUITING

    Lausanne, Canton of Vaud, Switzerland

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