Clinical Trials for Deep Vein Thrombosis
This article provides detailed information about 4 ongoing clinical trials investigating treatments and prevention strategies for deep vein thrombosis and related blood clotting conditions. These studies are taking place across multiple European countries and are testing medications including rosuvastatin, anticoagulants, apixaban, and BAY 3018250.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- France
- Study on Rosuvastatin for Reducing Blood Clots in Patients with Deep Vein Thrombosis or Pulmonary Embolism
- Study on the Best Antithrombotic Therapy for Patients with Acute Venous Thromboembolism Using Tinzaparin Sodium and Drug Combination
- Study on the Effectiveness and Safety of BAY 3018250 and Low Molecular Weight Heparin for Patients with Proximal Deep Vein Thrombosis
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Norway
- Slovakia
- Spain
Study on Rosuvastatin for Reducing Blood Clots in Patients with Deep Vein Thrombosis or Pulmonary Embolism
This trial is investigating whether rosuvastatin calcium, a medication commonly known as a statin, can help prevent blood clots from returning in patients who have already experienced deep vein thrombosis or pulmonary embolism. The study is being conducted in France and Norway.
Inclusion criteria: Patients eligible for this study must have a confirmed diagnosis of symptomatic proximal leg deep vein thrombosis or segmental or larger pulmonary embolism within the last 30 days. Both men and women can participate.
Exclusion criteria: The trial excludes pregnant or breastfeeding women, individuals with severe allergic reactions to the study medication, those taking medications that might interfere with rosuvastatin, people with severe liver or kidney disease, individuals with recent significant bleeding problems or major surgery, those with uncontrolled high blood pressure, and people with a history of alcohol or drug abuse. Patients with certain uncontrolled heart rhythm problems are also excluded.
Focus: The main goal is to determine if rosuvastatin calcium can lower the rate of major blood clot events in patients with a history of blood clots. The study will also examine other outcomes such as post-thrombotic syndrome, heart attacks, and strokes. Participants will be randomly assigned to receive either rosuvastatin calcium 20 mg tablets or a placebo and will be monitored regularly for safety and effectiveness. The trial is expected to continue until the end of 2027.
Investigational drug: Rosuvastatin is the medication being tested in this trial. While statins are primarily used to lower cholesterol, this study is exploring whether rosuvastatin can also help prevent recurrent blood clot events by reducing inflammation and stabilizing blood vessel walls.
Study on the Best Antithrombotic Therapy for Patients with Acute Venous Thromboembolism Using Tinzaparin Sodium and Drug Combination
This French trial is comparing different treatment approaches for patients with acute venous thromboembolism who are also taking antiplatelet medications for heart-related conditions. The study examines whether using full-dose anticoagulant therapy alone is safer than combining it with antiplatelet therapy.
Inclusion criteria: Participants must have an acute venous thromboembolism event with confirmed proximal deep vein thrombosis or pulmonary embolism. They must be prescribed full-dose anticoagulant therapy for at least 3 months and already be taking antiplatelet therapy for preventing heart and blood vessel diseases at the time of diagnosis. Both men and women are eligible.
Exclusion criteria: The study excludes patients with recent acute venous thromboembolism events who are currently on antiplatelet therapy for artery-related clot prevention, those outside the specified age range, and vulnerable populations.
Focus: The primary aim is to determine whether full-dose anticoagulant therapy alone reduces the risk of significant bleeding compared to combination therapy with antiplatelet medications. Various anticoagulants and antiplatelet medications will be used, including tinzaparin sodium, warfarin sodium, apixaban, dalteparin sodium, and others. Participants will be monitored for up to 12 months to assess bleeding events and other health outcomes.
Investigational drugs: The trial involves both anticoagulant therapy, which prevents blood clots from forming or growing, and antiplatelet therapy, which stops platelets from sticking together. The study compares using these medications alone versus in combination.
Study on Apixaban for Preventing Blood Clots in Leg Veins During Long-Distance Flights for Travelers at Risk
This German study is investigating whether a single dose of apixaban can prevent leg vein thrombosis in people traveling on long-distance flights. The trial focuses on prevention rather than treatment of existing blood clots.
Inclusion criteria: Participants must be legally competent adults aged 18 or older who are planning a long-haul flight lasting at least 6 hours each way, with a return trip within 4 weeks. Women who are potentially pregnant must be willing to undergo pregnancy testing and use effective contraception throughout the study.
Exclusion criteria: The study excludes individuals with a history of symptomatic leg vein thrombosis, those outside the specified age range, and vulnerable populations.
Focus: The trial aims to determine if taking a single 2.5 mg dose of apixaban before both the outbound and return flights can significantly reduce the risk of developing leg vein thrombosis during air travel. Participants will receive either apixaban or a placebo, and the study will monitor for any clinically relevant blood clots and bleeding events. Recruitment is expected to start in 2026, with the trial running until 2028.
Investigational drug: Apixaban is an oral anticoagulant that works by inhibiting Factor Xa, a protein crucial to blood clot formation. This study tests whether a preventive dose can protect air travelers from developing blood clots during long flights.
Study on the Effectiveness and Safety of BAY 3018250 and Low Molecular Weight Heparin for Patients with Proximal Deep Vein Thrombosis
This multi-country trial is taking place across 11 European nations including Germany, Bulgaria, Czechia, Slovakia, Belgium, Italy, Netherlands, France, Hungary, Greece, and Spain. It is studying an investigational medication called BAY 3018250 for treating proximal deep vein thrombosis.
Inclusion criteria: Eligible participants are men and postmenopausal women or those who have had a hysterectomy, aged 18 years or older. They must have acute symptomatic proximal deep vein thrombosis confirmed by compression ultrasound, with symptoms lasting 14 days or less. The blood clot must be in specific veins including the popliteal, femoral, common femoral, or external iliac vein. Participants must currently be receiving treatment with low molecular weight heparins or direct oral anticoagulants and have a body weight between 50 kg and 130 kg.
Exclusion criteria: The trial excludes patients with allergic reactions to the study medication, severe liver disease, uncontrolled high blood pressure, those who are pregnant or breastfeeding, individuals with a stroke in the past 6 months, those with active bleeding or high bleeding risk, patients who had major surgery in the past 30 days, those with cancer not in remission, and individuals currently participating in another clinical trial.
Focus: The study aims to evaluate how effectively BAY 3018250 can dissolve blood clots and assess its safety in patients with proximal deep vein thrombosis. The medication is given as an infusion under the skin. Participants will undergo regular ultrasound assessments at 6 hours, 24 hours, Day 7, and Day 30 to measure clot reduction. The trial will also monitor bleeding events up to Day 15 and evaluate changes in leg pain and functional status. Follow-up continues through Day 90 to check for any recurrence of blood clots. The study is expected to conclude by October 2025.
Investigational drug: BAY 3018250 is an experimental thrombolytic agent designed to break down blood clots. It works by enhancing the body’s natural ability to dissolve clots through activation of enzymes that break down fibrin, a key component of blood clots. This medication is still under investigation and not yet widely available in medical practice.
Summary
These four ongoing clinical trials represent diverse approaches to managing deep vein thrombosis and related conditions. The studies span across multiple European countries, with particularly strong representation in France and Germany. One trial is being conducted across 11 countries, demonstrating the international collaborative effort in researching blood clot treatments.
The trials investigate different aspects of blood clot management, from prevention during air travel to treatment of acute cases and prevention of recurrence. The medications being studied include both established drugs being tested for new uses, such as rosuvastatin and apixaban, as well as experimental medications like BAY 3018250. Two trials focus on optimizing anticoagulant therapy approaches, while another explores prevention strategies for travelers.
Each study addresses specific patient populations with distinct needs, ranging from patients with recent blood clots requiring immediate treatment to travelers seeking prevention during long flights. The trials are expected to provide valuable information about safer and more effective ways to prevent and treat blood clots in various clinical situations.
