Ongoing Clinical Trials for Venous Thrombosis
This article provides information about 2 ongoing clinical trials investigating treatments for preventing recurrent blood clots in patients who have experienced venous thrombosis. These studies are testing medications that may help reduce the risk of future blood clot episodes in the veins and lungs.
Clinical trial locations
- France
- Italy
- Norway
Study on Rosuvastatin for Reducing Blood Clots in Patients with Deep Vein Thrombosis or Pulmonary Embolism
This trial is being conducted in France and Norway and focuses on testing whether Rosuvastatin Calcium can help prevent blood clots from coming back in patients who have already experienced them. The study is expected to continue until the end of 2027.
Main inclusion criteria: Patients can join if they have symptoms and a confirmed diagnosis of a blood clot in the deep veins of the leg (above a specific point called the trifurcation of the popliteal vein) or a blockage in the lung’s arteries (pulmonary embolism that is segmental or larger). The diagnosis must have been made within the last 30 days. Both men and women are eligible to participate.
Main exclusion criteria: Patients cannot participate if they are pregnant or breastfeeding, have severe allergic reactions to the study medication, are taking medications that might interfere with the study drug, have severe liver or kidney disease, have had recent significant bleeding problems or major surgery, have uncontrolled high blood pressure, have a history of alcohol or drug abuse, have certain uncontrolled heart rhythm problems, or are unable to follow study procedures or attend scheduled visits.
Focus and goal: 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 will be randomly assigned to receive either the active medication or a placebo (a substance with no active medication). The study will monitor participants over time to observe any differences in blood clot recurrence between the two groups. Researchers will also look at 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: Rosuvastatin is the medication being tested in this trial. It is a type of statin commonly used to lower cholesterol levels, but here it is being studied for its potential to prevent further blood clot events. The medication works by inhibiting an enzyme called HMG-CoA reductase, which may help reduce inflammation and stabilize blood vessel walls. Participants take the medication orally in 20 mg tablet form.
Study on Sulodexide for Preventing Recurrence of Blood Clots in Elderly Patients After First Episode of Deep Vein Thrombosis or Pulmonary Embolism
This trial is taking place in Italy and focuses specifically on elderly patients aged 75 and older who have recently experienced their first episode of a blood clot. The study is expected to conclude by January 2027.
Main inclusion criteria: Patients must have experienced their first episode of a blood clot in the deep veins of the leg or in the lungs. They must be 75 years old or older at the time of joining. Participants must have at least one known risk factor for bleeding, such as high blood pressure, previous significant bleeding, kidney problems, low platelet count, diabetes, current use of aspirin, frequent falls, use of certain pain relievers, liver problems, previous stroke, low red blood cell count, poor control of blood-thinning treatment, or alcohol abuse. Patients must have already completed at least 3 months of blood-thinning treatment without stopping for more than 30 days, and they should not need blood-thinning treatment for any other reason.
Main exclusion criteria: Patients younger than 75 years old cannot participate. Those who have not had a recent episode of deep vein thrombosis or pulmonary embolism are excluded. Patients who are part of vulnerable populations, such as those who cannot give consent or have certain disabilities, cannot join. Patients with a high risk of major bleeding are also excluded.
Focus and goal: The trial aims to verify whether Sulodexide can reduce the chances of blood clots returning by 35% compared to a placebo in elderly patients. The study will compare two different doses of Sulodexide with a placebo capsule that looks like the medication but contains no active substance. Participants will be monitored for up to 12 months to track any new episodes of blood clots, overall mortality related to blood clots, and any major bleeding incidents. The study also assesses the safety of Sulodexide to ensure it does not cause more major bleeding than expected.
Investigational drug: Sulodexide (VESSEL®) is an antithrombotic medication, meaning it helps prevent blood clot formation. It works at the molecular level by enhancing the activity of antithrombin III and inhibiting factor Xa, which helps prevent clots from forming. The medication is administered orally in soft capsule form, with dosage and frequency depending on the assigned treatment group.
Summary
Both ongoing trials focus on preventing recurrent blood clots in patients who have already experienced an episode of venous thrombosis. The trials are testing different approaches: one uses Rosuvastatin, a statin medication traditionally used for cholesterol management, while the other uses Sulodexide, an antithrombotic agent specifically designed to prevent clot formation.
Geographically, these trials are concentrated in European countries, with the Rosuvastatin study taking place in France and Norway, and the Sulodexide study conducted in Italy. The Sulodexide trial specifically targets elderly patients aged 75 and older with additional bleeding risk factors, while the Rosuvastatin trial has a broader age range. Both studies employ randomized, placebo-controlled designs to ensure reliable results, and both will monitor participants for blood clot recurrence and safety outcomes over extended periods.
