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Study on Sulodexide for Preventing Recurrence of Blood Clots in Elderly Patients After First Episode of Deep Vein Thrombosis or Pulmonary Embolism

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What is this trial about?

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

This clinical trial is focused on studying the prevention of recurrent episodes of Venous Thromboembolism (VTE) in elderly patients. VTE is a condition where blood clots form in the veins, which can lead to serious health issues like Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE). The study involves the use of a medication called Sulodexide, marketed under the name VESSEL® 250 ULS capsule molli. Sulodexide is an antithrombotic, which means it helps prevent the formation of blood clots. The trial will compare the effects of two different doses of Sulodexide with a placebo, which is a capsule that looks like the medication but does not contain the active substance.

The purpose of the study is to verify the effectiveness and safety of Sulodexide in reducing the chances of VTE coming back in patients aged 75 years and older who have recently experienced a first episode of DVT or PE. The study will monitor the participants over a period to see if Sulodexide can lower the risk of new blood clots by 35% compared to the placebo. Additionally, the study will assess the safety of Sulodexide by checking for any major bleeding events, aiming to show that it is not inferior to the placebo in terms of safety.

Participants in the study will take either Sulodexide or the placebo orally, in the form of soft capsules. The trial will last for a maximum of 12 months, during which the health of the participants will be closely monitored to track any new episodes of VTE, overall mortality due to VTE, and any major bleeding incidents. The study aims to provide valuable information on the potential benefits and risks of using Sulodexide for preventing recurrent VTE in elderly patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria. These include having experienced a first episode of deep vein thrombosis (DVT) or pulmonary embolism (PE), being 75 years or older, and having completed at least three months of anticoagulant therapy without interruption for more than 30 days.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of three treatment groups. Treatment A and Treatment B involve different doses of sulodexide (VESSEL®), while Treatment C involves a placebo. The placebo is a soft capsule similar in appearance to the active medication.

  3. Step 3

    Medication administration

    The medication is administered orally in the form of a soft capsule. The specific dosage and frequency depend on the assigned treatment group. The duration of the treatment is determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for new episodes of venous thromboembolism, overall mortality due to VTE, and any major bleeding events. Monitoring is conducted according to the criteria set by the International Society on Thrombosis and Haemostasis (ISTH).

  5. Step 5

    Completion of the study

    The study is expected to conclude by January 30, 2027. Upon completion, data on the efficacy and safety of the treatments will be analyzed, focusing on the prevention of recurrent venous thromboembolism and the incidence of major bleeding.

Who can join the trial?

19 criteria

  • Patients who have experienced their first episode of a blood clot in the deep veins of the leg (known as proximal lower extremity DVT) or a blood clot in the lungs (known as PE).
  • Patients who are 75 years old or older at the time of joining the study.
  • Patients with at least one known risk factor for bleeding, such as:
    • High blood pressure (hypertension)
    • Previous significant bleeding event
    • Kidney problems (renal failure) with a specific measurement less than 60 ml/min
    • Low platelet count (thrombocytopenia) with less than 100,000 per mm3
    • Diabetes
    • Currently taking aspirin (ASA) with a maximum dose of 140 mg per day
    • Frequent falls, more than 2 per year
    • Use of certain pain relievers known as non-steroidal anti-inflammatory drugs
    • Liver problems (liver failure) with specific enzyme levels more than 3 times the normal limit
    • Previous stroke
    • Low red blood cell count (anemia) with hemoglobin less than 100 g/L
    • Poor control of blood-thinning treatment, with a specific measure (TTR) less than 60%
    • Alcohol abuse
    • Patients of any gender.
    • Patients who have already completed at least 3 months of blood-thinning treatment (anticoagulant therapy) and have not stopped this treatment for more than 30 days.
    • Patients who do not need blood-thinning treatment for any other reason.
    • Patients who are able to understand the study and agree to participate by signing a consent form.

Who cannot join the trial?

4 criteria

  • Patients who are younger than 75 years old cannot participate.
  • Patients who have not had a recent episode of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE) cannot participate. Deep Vein Thrombosis (DVT) is a condition where a blood clot forms in a deep vein, usually in the leg. Pulmonary Embolism (PE) is a condition where a blood clot travels to the lungs.
  • Patients who are part of a vulnerable population, such as those who cannot give consent or have certain disabilities, cannot participate.
  • Patients who have a high risk of major bleeding cannot participate. Major bleeding refers to serious bleeding that may require medical attention.
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Investigated drugs

Sulodexide (VESSEL®) is being studied for its ability to prevent the recurrence of venous thromboembolism (VTE) in elderly patients who have experienced a recent episode of deep vein thrombosis (DVT) or pulmonary embolism (PE). The trial aims to determine if Sulodexide can reduce the chances of VTE happening again by 35% compared to not taking the medication. Additionally, the study is assessing the safety of Sulodexide, ensuring that it does not cause more major bleeding than expected.

What is already known about the treatment

Sulodexide (VESSEL®) – Sulodexide is administered orally in capsule form. It is currently being studied for its effectiveness in preventing the recurrence of venous thromboembolism (VTE) in elderly patients who have experienced a first episode of this condition. The main therapeutic indication is the prevention of VTE recurrence. At the molecular level, Sulodexide works by enhancing the activity of antithrombin III and inhibiting factor Xa, which helps to prevent blood clot formation. It is classified pharmacologically as an antithrombotic agent.

Investigated diseases

Venous Thromboembolism (VTE) – This condition involves the formation of blood clots in the veins, typically in the legs, known as deep vein thrombosis (DVT), which can travel to the lungs, causing a pulmonary embolism (PE). It often occurs after periods of immobility, surgery, or trauma. The disease can cause swelling, pain, and redness in the affected area. If a clot travels to the lungs, it may lead to chest pain, difficulty breathing, and rapid heart rate. VTE can recur, especially if the underlying risk factors are not addressed. Prevention of recurrence is crucial, particularly in elderly patients who have experienced a recent episode.
Trial detailsLast updated 7 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-517796-21-00Estimated enrolment1 455 patientsSponsorFondazione Arianna Anticoagulazione

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