Pelvic venous thrombosis Trials in Disease

Study on Rosuvastatin for Reducing Blood Clots in Patients with Deep Vein Thrombosis or Pulmonary Embolism

This clinical trial is investigating whether Rosuvastatin Calcium can help reduce the risk of recurring blood clots in patients who have already experienced venous thromboembolism. The trial is being conducted in France and Norway and is expected to continue until the end of 2027.

Main inclusion criteria:

• Patients must have symptoms of their condition
• A confirmed diagnosis of proximal leg deep vein thrombosis (a blood clot in the deep veins of the leg above the trifurcation of the popliteal vein) within the last 30 days
• Patients may also have pulmonary embolism (a blockage in one of the lung's arteries that is segmental or larger)
• Both male and female patients are eligible

Main exclusion criteria:

• Pregnant or breastfeeding women
• History of severe allergic reactions to the study medication
• Currently taking medications that might interfere with rosuvastatin
• Severe liver or kidney disease
• Recent history of significant bleeding problems or major surgery
• Uncontrolled high blood pressure or certain heart rhythm problems
• History of alcohol or drug abuse
• Unable to follow study procedures or attend scheduled visits

Focus and goal of the trial:

The trial aims to determine whether taking Rosuvastatin Calcium can lower the rate of major blood clot events in patients who have already experienced a clot. Participants are randomly assigned to receive either the active medication (20 mg rosuvastatin calcium tablets taken orally) or a placebo. The study monitors participants over time to observe differences in blood clot recurrence between the two groups. Researchers will also track other health outcomes, such as the development of post-thrombotic syndrome (a condition that can occur after a blood clot) and other vascular events like heart attacks or strokes.

Investigational drug:

The medication being tested is Rosuvastatin, a type of statin traditionally used to lower cholesterol levels. In this study, it is being explored for its potential to prevent further venous thromboembolism events. At the molecular level, rosuvastatin works by blocking an enzyme called HMG-CoA reductase, which plays a key role in cholesterol production in the liver. This action may also reduce inflammation and help stabilize blood vessel walls, potentially preventing new clots from forming.