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Study on Rosuvastatin for Reducing Blood Clots in Patients with 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 effects of a medication called Rosuvastatin Calcium in patients who have experienced certain types of blood clots. The diseases being studied include Pulmonary Embolism, Venous Thromboembolism, and Deep Vein Thrombosis. These conditions involve the formation of blood clots in the veins, which can be serious and require medical attention. The trial will compare the effects of Rosuvastatin Calcium to a placebo, which is a substance with no active medication, to see if the medication can help reduce the occurrence of these blood clots.

The purpose of the study is to determine if taking Rosuvastatin Calcium can lower the rate of major blood clot events in patients who have already had a clot. Participants in the study will be randomly assigned to receive either Rosuvastatin Calcium or a placebo. The study will monitor the participants over a period of time to observe any differences in the recurrence of blood clots between the two groups. The trial will also look at other health outcomes, such as the development of post-thrombotic syndrome, which is a condition that can occur after a blood clot, and other vascular events like heart attacks or strokes.

Throughout the study, participants will be regularly checked to ensure their safety and to gather information on how the medication is affecting their health. The trial is expected to continue until the end of 2027, providing valuable insights into the potential benefits of Rosuvastatin Calcium for patients with these types of blood clots.

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, participation is confirmed based on specific criteria. This includes having a confirmed diagnosis of a blood clot in the leg or lung within the last 30 days.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the active medication, rosuvastatin calcium, or a placebo. This process ensures that the study results are unbiased.

  3. Step 3

    Medication administration

    Participants take the assigned medication orally. The active medication is rosuvastatin calcium in a 20 mg tablet form. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, participants are monitored for any symptoms of recurrent major blood clots, such as those in the leg or lung. This monitoring continues until the end of the study.

  5. Step 5

    Completion of the trial

    The study concludes with the final follow-up, which assesses the occurrence of any major or minor blood clots, as well as other health events like heart attacks or strokes. The study is expected to end by December 31, 2027.

Who can join the trial?

6 criteria

  • The patient must have a **symptomatic** condition, which means they are showing symptoms.
  • The patient must have a **confirmed** case of **proximal leg DVT**. This is a blood clot in the deep veins of the leg, above a specific point called the trifurcation of the popliteal vein.
  • The patient may also have **PE**, which stands for **Pulmonary Embolism**. This is a blockage in one of the lung's arteries, and it must be segmental or larger.
  • The diagnosis of DVT or PE must have been made in the last 30 days.
  • Both **male** and **female** patients are eligible to participate.
  • The study does not include vulnerable populations, which means it is not designed for groups that might need special protection.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with a history of severe allergic reactions to the study medication are excluded.
  • Patients currently taking medications that might interfere with the study drug are not eligible.
  • People with severe liver or kidney disease cannot join the study.
  • Individuals with a recent history of significant bleeding problems are excluded.
  • Patients who have had a recent major surgery are not eligible.
  • Those with uncontrolled high blood pressure cannot participate.
  • Individuals with a history of alcohol or drug abuse are excluded.
  • Patients with certain heart conditions, such as uncontrolled heart rhythm problems, cannot join the study.
  • People who are unable to follow the study procedures or attend scheduled visits are not eligible.
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Investigated drugs

Rosuvastatin is a medication used in this trial to see if it can help reduce the risk of recurrent major venous thromboembolism (VTE) events, such as deep vein thrombosis (DVT) or pulmonary embolism (PE), in patients who have already experienced these conditions. It is a type of statin, which is commonly used to lower cholesterol levels in the blood, but in this study, it is being tested for its potential benefits in preventing further VTE events.

What is already known about the treatment

Rosuvastatin – Rosuvastatin is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in reducing venous thromboembolism events, such as pulmonary embolism and deep vein thrombosis. The main therapeutic indication being explored is its ability to prevent recurrent major venous thromboembolism events. At the molecular level, rosuvastatin works by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in cholesterol synthesis in the liver, potentially leading to reduced inflammation and stabilization of blood vessel walls. It is classified pharmacologically as a statin, a type of medication primarily used to lower cholesterol levels.

Investigated diseases

  • Pulmonary Embolism

    Pulmonary embolism occurs when a blood clot blocks one or more arteries in the lungs. This blockage can restrict blood flow, leading to reduced oxygen levels in the blood. Symptoms may include sudden shortness of breath, chest pain, and coughing, sometimes with blood. The condition can develop rapidly and requires prompt attention to prevent complications. It often results from clots that travel from the legs or other parts of the body.

  • Venous Thromboembolism

    Venous thromboembolism is a condition that includes both deep vein thrombosis and pulmonary embolism. It involves the formation of blood clots in the veins, which can travel to the lungs and cause a blockage. Symptoms may vary depending on the location of the clot but can include swelling, pain, and redness in the affected area. The condition can develop over time and may be influenced by factors such as immobility or surgery.

  • Deep Vein Thrombosis

    Deep vein thrombosis is characterized by the formation of a blood clot in a deep vein, usually in the legs. This can cause swelling, pain, and tenderness in the affected limb. The condition can develop gradually and may be associated with prolonged periods of inactivity. If a clot breaks free, it can travel to the lungs and cause a pulmonary embolism. Risk factors include certain medical conditions, surgeries, and long periods of immobility.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504486-23-00Protocol codeCTO # 2095Estimated enrolment2 500 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

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