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Enoxaparin or drug combination versus no anticoagulant treatment for incidental subsegmental pulmonary embolism in cancer patients

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on patients who have cancer and are found to have an incidental Pulmonary Embolism, specifically a small clot in a branch of the lung artery called a subsegmental clot that is discovered by chance. The purpose is to compare the effects of starting an anticoagulant medication versus not giving one, in order to see how this influences survival, bleeding, repeat clotting, continuation of cancer therapy, and overall quality of life.

Participants are randomly assigned to receive either a daily oral pill such as edoxaban or apixaban, an injectable medicine such as dalteparin, tinzaparin, enoxaparin, or rivaroxaban, or a placebo that looks the same but contains no active drug. Over several months, they will have regular check‑ups that may include simple scans of the lungs to confirm whether the clot has changed, and they will complete questionnaires about their daily well‑being. The study does not require any special procedures beyond the usual care for cancer and clot management.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and baseline assessment

    You attend the first study visit after joining the trial.

    Baseline information is collected, including medical history and the diagnosis of incidental subsegmental pulmonary embolism in a cancer patient.

    The study team explains the purpose of the trial and the possible options you may receive.

  2. Step 2

    Randomization to treatment group

    You are randomly assigned to one of two groups: observation only (no anticoagulant medication) or anticoagulant treatment.

    The assignment is made by a computer system to ensure fairness.

  3. Step 3

    Start of anticoagulant medication (if assigned to treatment)

    If you are assigned to the treatment group, you begin taking an anticoagulant medication as directed by the study protocol.

    The possible medications and their listed doses are:

    edoxaban: 60 mg taken orally.

    dalteparin: 18000 IU/kg given by subcutaneous injection.

    tinzaparin: 175 IU/kg given by subcutaneous injection.

    apixaban: 20 mg taken orally.

    enoxaparin: 2 mg/kg given by subcutaneous injection.

    rivaroxaban: 30 mg taken orally.

    The exact medication you receive, the timing of each dose, and the total length of treatment are specified in the study instructions you receive at this visit.

  4. Step 4

    Regular monitoring visits

    You return to the study clinic at scheduled intervals for safety checks.

    During each visit, vital signs, blood tests, and any signs of bleeding or new clotting are assessed.

    The study team records any adverse events you experience.

  5. Step 5

    Imaging assessments

    At predetermined times, imaging studies (such as computed tomography scans) are performed to evaluate the status of the pulmonary embolism.

    The results help determine whether the clot has resolved, remained stable, or progressed.

  6. Step 6

    Quality‑of‑life questionnaires

    You complete standardized questionnaires to assess your quality of life.

    The tools used are the EQ‑5D‑5L, the PEmb‑QoL questionnaire, and the EORTC QLQ‑C30.

    These questionnaires are administered at baseline and at follow‑up visits.

  7. Step 7

    Ongoing follow‑up

    You continue to be followed for the duration of the trial as defined by the study protocol.

    Follow‑up includes further monitoring visits, imaging, and questionnaire completion until the study end date.

  8. Step 8

    Final assessment and study completion

    At the end of the study period, a final assessment is performed.

    This includes a last imaging study, final blood tests, and completion of the quality‑of‑life questionnaires.

    After this visit, your participation in the trial is concluded.

Who can join the trial?

6 criteria

  • Have active cancer – meaning you currently have a cancer diagnosis and are receiving treatment.
  • Be 18 years of age or older.
  • Have three or fewer incidental subsegmental pulmonary embolisms – tiny blood clots in small lung vessels that were found by chance on a routine scan.
  • Plan to have a routine follow‑up CT scan (a detailed X‑ray picture of the chest) within the next 3 to 4 months.
  • Be able to give informed consent – you understand the study and agree to take part.
  • Have access to a smartphone – either you or a family member can use one for study communication.

Who cannot join the trial?

8 criteria

  • Having another medical reason that requires blood‑thinning medication (anticoagulation) right now.
  • Already taking blood‑thinning medication (anticoagulants) at the start of the study.
  • Showing signs of a blood clot in a deep leg vein, known as deep venous thrombosis.
  • Had a previous blood clot in the veins, called venous thromboembolism, at any time in the past 10 years.
  • Being unable to move for more than five days in a row (immobilisation > 5 days).
  • Having had cancer surgery within the last month.
  • Not being able to read and speak Danish well enough to understand and agree to the study (informed consent).
  • Being pregnant.
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Investigated drugs

  • Edoxaban

    is a pill taken by mouth that helps prevent blood clots by blocking a protein needed for clot formation. In this study, it is being used to see if starting an oral anticoagulant improves outcomes for cancer patients who have a small, incidental pulmonary embolism.

  • Dalteparin

    is an injection given under the skin that acts as an anticoagulant, stopping the blood’s ability to form clots. The trial includes it as one of the injectable options being tested to determine whether early treatment with a subcutaneous anticoagulant is beneficial compared with not treating.

  • Tinzaparin

    is also a subcutaneous injection that works as an anticoagulant, helping to keep blood from clotting excessively. It is part of the group of injectable drugs evaluated in the study to assess the effects of starting anticoagulation in cancer patients with a small pulmonary embolism.

  • Apixaban

    is an oral tablet that prevents clot formation by inhibiting a key clotting factor. In the trial, it is examined as another pill option to see if beginning oral anticoagulation early improves survival and reduces complications.

  • Enoxaparin

    is a low‑molecular‑weight heparin given as a subcutaneous injection. It works by reducing the blood’s tendency to clot. The study uses it as one of the injectable anticoagulants to compare the benefits of treating versus not treating the embolism.

  • Rivaroxaban

    is a pill taken by mouth that blocks a clot‑forming protein, helping to keep blood thin. It is included in the trial as an oral anticoagulant option to evaluate whether starting treatment early helps cancer patients with an incidental subsegmental pulmonary embolism.

What is already known about the treatment

  • Edoxaban

    Edoxaban is taken as an oral tablet, swallowed with water. It is an approved medication widely used worldwide for preventing and treating blood clots, including pulmonary embolism. It works by directly blocking a protein called factor Xa, which helps stop clot formation. It belongs to the class of oral direct factor Xa inhibitors.

  • Dalteparin

    Dalteparin is given by a subcutaneous injection, placed under the skin with a small needle. It is an approved low‑molecular‑weight heparin used to prevent and treat clotting problems in many patients. It enhances the body's natural inhibitor antithrombin, which then reduces activity of factor Xa and helps dissolve clots. It is classified as a low‑molecular‑weight heparin.

  • Tinzaparin

    Tinzaparin is administered by subcutaneous injection under the skin. It is an approved low‑molecular‑weight heparin commonly prescribed for clot prevention and treatment. It works by boosting antithrombin activity, which blocks factor Xa and slows clot growth. It falls under the low‑molecular‑weight heparin drug class.

  • Apixaban

    Apixaban is taken as an oral tablet that is swallowed with water. It is an approved drug used worldwide for preventing and treating blood clots such as deep‑vein thrombosis and pulmonary embolism. It directly inhibits factor Xa, a key protein needed for clot formation. It is categorized as an oral direct factor Xa inhibitor.

  • Enoxaparin

    Enoxaparin is given by subcutaneous injection, placed just under the skin. It is an approved low‑molecular‑weight heparin widely used to prevent and treat clotting events. It increases the effect of antithrombin, which then blocks factor Xa and helps prevent clots from growing. It belongs to the low‑molecular‑weight heparin class.

  • Rivaroxaban

    Rivaroxaban is taken as an oral tablet, swallowed with water. It is an approved medication used globally for preventing and treating blood clots, including pulmonary embolism. It works by directly blocking factor Xa, stopping the clotting cascade. It is classified as an oral direct factor Xa inhibitor.

Investigated diseases

  • Subsegmental pulmonary embolism

    A blockage of a small branch of the lung artery caused by a blood clot that travels from elsewhere in the body. The clot can reduce blood flow to a tiny region of lung tissue. Over time, the affected area may become less oxygen‑rich, leading to subtle changes on imaging. The clot may stay the same size, shrink, or dissolve on its own. Symptoms, if present, are often mild or absent, allowing the condition to be discovered incidentally during scans.

  • Malignant neoplasm

    An abnormal growth of cells that have the ability to invade nearby tissues and spread to other parts of the body. The tumor usually begins as a small mass that enlarges as cells divide uncontrollably. As it grows, it can affect the function of the organ where it started. Cells may break away and travel through the bloodstream or lymphatic system to form new growths elsewhere. The disease progresses through stages that reflect its size and spread.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524110-28-00Protocol codePEACEEstimated enrolment234 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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