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Study on the Best Antithrombotic Therapy for Patients with Acute Venous Thromboembolism Using Tinzaparin Sodium and Drug Combination

Fast replyRegistered drugNo placebo
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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 best treatment options for patients with acute venous thromboembolism (VTE), a condition where blood clots form in the veins, often in the legs, and can travel to the lungs, causing a blockage known as a pulmonary embolism. The study will compare the effectiveness of using full-dose anticoagulant therapy alone versus combining it with antiplatelet therapy. Anticoagulants are medications that help prevent blood clots, while antiplatelets are used to prevent blood cells called platelets from clumping together, which can also lead to clots.

The medications being studied include INNOHEP (tinzaparin sodium), COUMADINE (warfarin sodium), Eliquis (apixaban), FRAGMINE (dalteparin sodium), Arixtra (fondaparinux sodium), SINTROM (acenocoumarol), HEPARINE CHOAY (heparin sodium), KARDEGIC (d,l-lysine acetylsalicylate), CALCIPARINE (heparin calcium), LOVENOX (enoxaparin sodium), Xarelto (rivaroxaban), and Plavix (clopidogrel). Some participants will receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The purpose of the study is to determine if using full-dose anticoagulant therapy alone reduces the risk of significant bleeding compared to using it in combination with antiplatelet therapy. Participants will be monitored for up to 12 months to assess the occurrence of bleeding and other related health events. The study aims to provide insights into the safest and most effective treatment approach for patients with acute VTE who are also taking antiplatelet medications for other heart-related conditions.

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 trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide consent to participate.

    You will undergo an initial assessment to confirm eligibility, which includes checking for acute venous thromboembolism (VTE) and the need for full-dose anticoagulant therapy.

  2. Step 2

    Initial treatment phase

    You will begin treatment with a full-dose anticoagulant. The specific medication and dosage will be determined by the study protocol and your medical condition.

    Medications may include options such as tinzaparin sodium, warfarin sodium, apixaban, or others, administered either orally or by injection.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the trial, you will continue to receive the assigned treatment. The duration of this phase is at least 3 months, but it may extend up to 12 months.

    Regular monitoring will be conducted to assess your response to the treatment and to check for any side effects, such as bleeding.

  4. Step 4

    Follow-up assessments

    Periodic follow-up assessments will be scheduled to evaluate your health status and the effectiveness of the treatment.

    These assessments will include checking for any recurrent VTE or cardiovascular events.

  5. Step 5

    Completion of the trial

    At the end of the treatment period, a final assessment will be conducted to gather data on your health outcomes.

    You will be informed about the results of the trial and any further steps, if necessary.

Who can join the trial?

6 criteria

  • Patients must have an acute venous thromboembolism (VTE) event, which means a sudden blockage in a vein, usually in the leg or lung.
  • Patients must have a confirmed case of proximal deep-vein thrombosis (DVT) or pulmonary embolism (PE). Proximal DVT means a blood clot in a large vein in the leg, such as the popliteal vein or a vein closer to the body.
  • Patients need to be prescribed full-dose anticoagulant therapy for at least 3 months. Anticoagulant therapy involves taking medication to prevent blood clots.
  • Patients must be taking antiplatelet therapy for the prevention of heart and blood vessel diseases at the time of their VTE diagnosis. Antiplatelet therapy involves medication that stops blood cells called platelets from sticking together and forming clots.
  • Both male and female patients are eligible to participate.
  • Patients should not be part of a vulnerable population, meaning they should not have additional conditions that make them more at risk.

Who cannot join the trial?

4 criteria

  • Patients who have had a recent **acute venous thromboembolism event**. This means a sudden blockage in a vein, usually in the legs, caused by a blood clot.
  • Patients who are currently taking **antiplatelet therapy** for preventing blood clots in arteries. Antiplatelet therapy involves medications that stop blood cells called platelets from sticking together and forming clots.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means groups of people who might be at higher risk of harm or exploitation.
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Investigated drugs

  • Anticoagulant Therapy

    is a type of medication that helps prevent blood clots from forming or growing larger. In this trial, it is used to reduce the risk of bleeding in patients who have experienced a venous thromboembolism (VTE), which is a condition where blood clots form in the veins. The goal is to see if using only this medication is better at preventing bleeding compared to using it together with another type of medication.

  • Antiplatelet Therapy

    is a medication that helps stop blood cells called platelets from sticking together and forming clots. This therapy is often used to prevent clots in arteries, which can lead to heart attacks or strokes. In this trial, patients are already taking this medication for preventing artery-related issues, and the study is looking at how it works when combined with anticoagulant therapy in patients who have had a VTE.

What is already known about the treatment

Anticoagulant Therapy – This medication is administered orally or via injection to prevent blood clots. It is currently being studied in clinical trials to assess its effectiveness in reducing bleeding risks compared to a combination of anticoagulant and antiplatelet therapies in patients with acute venous thromboembolism (VTE) who are also on antiplatelets for arterial prevention. The main therapeutic use is to treat and prevent blood clots in veins, which can lead to serious conditions like pulmonary embolism. At the molecular level, anticoagulants work by inhibiting specific proteins in the blood that are necessary for clot formation. They are classified as antithrombotic agents, which help to reduce the formation of harmful clots in the blood vessels.

Investigated diseases

Acute Venous Thromboembolism – Acute venous thromboembolism (VTE) is a condition where blood clots form in the veins, typically in the deep veins of the legs, known as deep vein thrombosis (DVT), or in the lungs, known as pulmonary embolism (PE). The disease begins with the formation of a blood clot that can partially or completely block blood flow in the affected vein. If the clot dislodges, it can travel through the bloodstream and lodge in the lungs, causing a pulmonary embolism. Symptoms of DVT may include swelling, pain, and redness in the affected leg, while PE may cause shortness of breath, chest pain, and coughing. The progression of the disease can lead to complications such as post-thrombotic syndrome, characterized by chronic pain and swelling, or post-PE syndrome, which involves persistent respiratory issues. The condition requires careful management to prevent further clotting and associated complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500974-33-00Protocol code20PH285Estimated enrolment1 400 patientsSponsorCentre Hospitalier Universitaire De Saint Etienne

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