Pulmonary embolism – Trials in Disease

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Clinical Trials for Pulmonary Embolism

Pulmonary embolism is a serious condition where blood clots block arteries in the lungs, restricting blood flow and reducing oxygen levels. Currently, 11 clinical trials are evaluating various treatment approaches for this condition, including blood-thinning medications, clot-dissolving therapies, and advanced procedures to remove clots. These studies are being conducted across multiple European countries and aim to improve treatment outcomes, reduce complications, and enhance quality of life for patients with pulmonary embolism.

Clinical trial locations

Study on Monitoring vs. Rivaroxaban for Patients with Low-Risk Isolated Subsegmental Pulmonary Embolism

This trial is studying the best approach for managing isolated subsegmental pulmonary embolism in patients who are considered low-risk. The study compares close monitoring without blood-thinning medication to treatment with Rivaroxaban, an oral anticoagulant. The goal is to determine which approach is more effective in preventing further blood clots while ensuring patient safety over a period of up to 90 days.

Who can participate: Adults aged 18 or older with a confirmed diagnosis of isolated subsegmental pulmonary embolism who are covered by health insurance can join. However, patients who are not considered low-risk, have other interfering medical conditions, cannot follow study procedures, are currently in another trial, are pregnant or breastfeeding, have severe allergies to study medications, require blood thinners for other reasons, have had recent major surgery, have a life expectancy of less than 6 months, or have substance abuse or mental health conditions cannot participate.

Main focus: The study evaluates whether clinical surveillance alone is as effective and safe as anticoagulation therapy with Rivaroxaban for preventing recurrent blood clots in low-risk patients. Researchers will monitor participants for symptoms of recurrent blood clots, significant bleeding, and overall health and quality of life.

Treatment used: Rivaroxaban, a blood-thinning medication taken orally as a film-coated tablet.

This trial is being conducted in France, Netherlands, and Belgium.

Study on Reduced Dose of Alteplase for Patients with Intermediate-High-Risk Acute Pulmonary Embolism

This study focuses on patients with intermediate-high-risk acute pulmonary embolism and tests whether a reduced dose of alteplase, a clot-dissolving medication, can effectively treat the condition while minimizing potential side effects. The trial compares this reduced dose treatment with a placebo to assess whether it can prevent death or serious heart-related complications within 30 days.

Who can participate: Adults aged 18 or older with confirmed acute pulmonary embolism, diagnosed within the last two weeks, who show signs of right heart dysfunction and elevated heart injury markers can participate. Patients must be able to join within 6 hours of receiving their heart test results and must sign a consent form and be covered by social security. Those not diagnosed with intermediate-high-risk acute pulmonary embolism, outside the specified age range, or part of a vulnerable population cannot participate.

Main focus: The study evaluates whether a reduced dose of thrombolytic therapy can effectively prevent death, hemodynamic decompensation, or recurrence of pulmonary embolism while maintaining safety. Researchers will monitor participants for 30 days to assess effectiveness and potential bleeding complications.

Treatment used: ACTILYSE, containing alteplase, administered intravenously to dissolve blood clots.

This trial is being conducted in Poland, Italy, Germany, France, Netherlands, Spain, Slovenia, and Austria.

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

This trial is testing whether Rosuvastatin Calcium, typically used to lower cholesterol, can help reduce the recurrence of blood clots in patients who have previously experienced deep vein thrombosis or pulmonary embolism. The study compares the medication to a placebo to see if it can lower the rate of major blood clot events and other complications.

Who can participate: Adults of any gender with a confirmed diagnosis of blood clots in the leg or lung within the last 30 days who have completed at least 3 months of blood-thinning treatment can participate. Patients who are pregnant, breastfeeding, have severe allergies to the study medication, are taking interfering medications, have severe liver or kidney disease, recent bleeding problems, recent major surgery, uncontrolled high blood pressure, history of alcohol or drug abuse, certain heart conditions, or cannot follow study procedures are excluded.

Main focus: The study examines whether Rosuvastatin Calcium can prevent recurrent major blood clot events in patients with a history of deep vein thrombosis or pulmonary embolism. Researchers will also monitor for post-thrombotic syndrome and other vascular events like heart attacks or strokes.

Treatment used: Rosuvastatin Calcium 20 mg tablets taken orally.

This trial is being conducted in France and Norway.

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

This study examines the best treatment approach for patients with acute venous thromboembolism who are also taking antiplatelet therapy for heart-related conditions. The trial compares using full-dose anticoagulant therapy alone versus combining it with antiplatelet therapy to determine which approach is safer in terms of bleeding risk.

Who can participate: Patients with acute venous thromboembolism, including confirmed proximal deep-vein thrombosis or pulmonary embolism, who are prescribed full-dose anticoagulant therapy for at least 3 months and are taking antiplatelet therapy can participate. Both male and female patients are eligible. Those with recent acute venous thromboembolism events, currently on antiplatelet therapy, outside the specified age range, or part of a vulnerable population cannot participate.

Main focus: The study determines whether using full-dose anticoagulant therapy alone reduces the risk of significant bleeding compared to combining it with antiplatelet therapy. Participants will be monitored for up to 12 months to assess bleeding events and other health outcomes.

Treatment used: Various anticoagulants including INNOHEP (tinzaparin sodium), COUMADINE (warfarin sodium), Eliquis (apixaban), and others, administered orally or by injection.

This trial is being conducted in France.

Study on the Effectiveness of Oxygen for Patients with Intermediate-Risk Acute Pulmonary Embolism

This trial evaluates whether using supplemental oxygen helps improve outcomes for patients with intermediate-risk acute pulmonary embolism. The study compares patients receiving oxygen to those who do not to determine if oxygen can prevent serious complications like hemodynamic collapse or death within 30 days.

Who can participate: Patients aged 18 to 64 years with pulmonary embolism confirmed by multidetector computed tomographic pulmonary angiography and right ventricular enlargement confirmed by computed tomography or echocardiography can participate. Both male and female patients are eligible. Those not diagnosed with acute pulmonary embolism, outside the specified age range, or part of a vulnerable population cannot participate.

Main focus: The study assesses whether supplemental oxygen can prevent hemodynamic collapse or death within 30 days after enrollment. Secondary outcomes include death from any cause, length of hospital stay, serious adverse events, major bleeding, and recurrent symptomatic venous thromboembolism.

Treatment used: Oxygen administered through inhalation gas.

This trial is being conducted in Spain and Italy.

Study of Catheter-Directed Thrombolysis Using Alteplase for Treatment of Intermediate-High Risk Acute Pulmonary Embolism

This study compares catheter-directed thrombolysis using Actilyse (alteplase) with standard blood-thinning therapy for patients with intermediate-high risk acute pulmonary embolism. The procedure delivers clot-dissolving medication directly to the blood clot through a thin tube to determine if it leads to better outcomes in terms of survival, prevention of new blood clots, and overall heart and lung function.

Who can participate: Adults aged 18 to 80 years with pulmonary embolism confirmed by CT scan within 14 days of symptom onset who have intermediate-high risk disease with positive sPESI score, right ventricle dysfunction, and elevated heart stress markers can participate. Patients younger than 18 or older than 75 years, with active bleeding or high bleeding risk, recent major surgery, history of recent stroke, severe thrombocytopenia, pregnancy or breastfeeding, life expectancy less than 30 days, severe kidney failure requiring dialysis, bleeding disorders, inability to take blood thinners, severe uncontrolled hypertension, active cancer, previous trial participation, inability to provide consent, or severe liver disease are excluded.

Main focus: The study evaluates whether catheter-directed thrombolysis leads to better outcomes compared to standard treatment, including improved survival, prevention of new blood clots, and overall heart and lung function recovery over a two-year period.

Treatment used: Actilyse (alteplase) delivered through an infusion directly to the blood clot, with a maximum daily dose of 20 milligrams.

This trial is being conducted in Czechia.

Study on Lung Function After Pulmonary Embolism Using Galligas and 68Ga-MAA in Patients with Pulmonary Embolism

This trial uses special imaging techniques with Galligas and 68Ga-MAA to assess lung function after pulmonary embolism. The study employs PET/CT imaging to create detailed pictures of the lungs and monitor changes in lung function over time following treatment.

Who can participate: Adults aged 18 or older who have been treated with blood-thinning medication for 3 to 8 months for pulmonary embolism, with a PembQol score of at least 10%, specific scores for breathing difficulties and impact on daily life, and an abnormal lung scan can participate. Patients with a history of pulmonary embolism, outside the specified age range, or part of a vulnerable population cannot participate.

Main focus: The study evaluates lung function using ventilation/perfusion PET/CT imaging to assess the pulmonary vascular obstruction index and regional lung functional volumes. Researchers will also monitor quality of life scores and overall health.

Treatment used: Pulmocis (suspension for injection containing human albumin as macroaggregates) and Pulmotec (inhalation powder containing graphite), along with Galligas and 68Ga-MAA for imaging purposes.

This trial is being conducted in France.

Study on Pulmonary Embolism: Comparing Iomeprol Dosages in CT Scans for Patients with Suspected Pulmonary Embolism

This trial compares different amounts of iodinated contrast (Iomeron 400 mgI/ml solution containing iomeprol) used during CT scans to diagnose pulmonary embolism. The study evaluates which dosage provides the best quality images for accurately detecting blood clots in the lungs.

Who can participate: Patients of any gender who are referred for a pulmonary CT angiography to check for pulmonary thromboembolism can participate. Those with a history of pulmonary embolism, outside the specified age range, or part of a vulnerable population cannot participate.

Main focus: The study determines which amount of iodinated contrast (20 mL, 30 mL, or 40 mL) provides the best images for diagnosing pulmonary embolism by measuring how well the contrast highlights blood vessels in the lungs.

Treatment used: Iomeron 400 mgI/ml solution for injection containing iomeprol, administered intravenously during CT scan.

This trial is being conducted in Spain.

Study on Sulodexide for Preventing Recurrence of Blood Clots in Elderly Patients After First Episode of Deep Vein Thrombosis or Pulmonary Embolism

This study tests whether Sulodexide (VESSEL® 250 ULS) can prevent recurrent venous thromboembolism in elderly patients who have experienced a first episode of deep vein thrombosis or pulmonary embolism. The trial compares two different doses of Sulodexide with a placebo to assess effectiveness and safety over a period of up to 12 months.

Who can participate: Patients aged 75 or older who have experienced their first episode of proximal lower extremity deep vein thrombosis or pulmonary embolism, have at least one bleeding risk factor, have completed at least 3 months of anticoagulant therapy without long interruptions, do not need anticoagulants for other reasons, and can provide informed consent can participate. Patients younger than 75 years, without recent deep vein thrombosis or pulmonary embolism episodes, part of vulnerable populations, or with high risk of major bleeding cannot participate.

Main focus: The study verifies whether Sulodexide can reduce the chances of venous thromboembolism recurrence by 35% compared to placebo while maintaining safety by ensuring it does not cause more major bleeding events.

Treatment used: VESSEL® 250 ULS containing Sulodexide, taken orally in soft capsule form.

This trial is being conducted in Italy.

Study on Treatments for Intermediate High-Risk Pulmonary Embolism: Comparing Percutaneous Embolectomy, Ultrasound-Assisted Thrombolysis with Alteplase, and Heparin

This study compares three different treatment methods for intermediate high-risk pulmonary embolism: percutaneous embolectomy (using the Flow Triever® system to physically remove clots), ultrasound-assisted thrombolysis (using the EKOS® system with alteplase), and heparin therapy. The goal is to determine which approach most effectively reduces blood clots in the lungs.

Who can participate: Adults aged 18 or older with intermediate high-risk pulmonary embolism confirmed by CT angiography, with visible blood clots in the main, lobar, or segmental pulmonary arteries, and symptoms lasting 14 days or less can participate. Patients with non-acute or non-intermediate high-risk pulmonary embolism, outside the specified age range, part of vulnerable populations, unable to provide informed consent, or with medical conditions interfering with study procedures are excluded.

Main focus: The study compares the effectiveness of three treatment approaches in reducing clot burden and improving patient outcomes. Researchers will monitor bleeding complications, length of hospital stay, and overall quality of life after treatment.

Treatment used: Flow Triever® system (percutaneous embolectomy device), EKOS® system with alteplase (ultrasound-assisted thrombolysis), or heparin (anticoagulant medication).

This trial is being conducted in Denmark.

Study on Tinzaparin and Dalteparin for Patients with Venous Thromboembolism

This trial compares two blood-thinning medications, TINZAPARIN and DALTEPARIN, for patients with venous thromboembolism. The study evaluates whether treatment with these low molecular weight heparins affects the risk of bleeding requiring medical attention or leading to death within 30 days of starting treatment.

Who can participate: Patients of any age and gender who are admitted to the hospital and have a medical need for treatment with low molecular weight heparin can participate. This includes vulnerable populations. Patients with bleeding disorders, currently taking other anticoagulant medications, severe liver or kidney disease, pregnancy or breastfeeding status, recent surgery, known heparin allergy, uncontrolled high blood pressure, history of stroke, or active cancer are excluded.

Main focus: The study assesses whether using TINZAPARIN or DALTEPARIN increases the risk of major bleeding requiring blood transfusion or death within 30 days. Researchers will also monitor pulmonary embolism occurrence, heparin-induced thrombocytopenia, overall survival rates, and length of hospital stays.

Treatment used: TINZAPARIN or DALTEPARIN administered through subcutaneous injection.

This trial is being conducted in Denmark.

Summary

These 11 clinical trials represent a comprehensive effort to improve treatment approaches for pulmonary embolism across various patient risk levels and clinical scenarios. The studies are concentrated primarily in Western European countries, with France hosting the highest number of trials, followed by Italy, Denmark, and the Netherlands. This geographic distribution reflects the strong research infrastructure and commitment to cardiovascular health in these regions.

The trials explore diverse treatment strategies, from conservative monitoring approaches for low-risk patients to advanced interventional procedures for high-risk cases. Several studies focus on optimizing doses of established clot-dissolving medications like alteplase, while others investigate novel applications of existing drugs such as Rosuvastatin for prevention of recurrent blood clots. A notable trend is the emphasis on patient-centered outcomes, with many trials measuring not only clinical effectiveness but also quality of life, hospital stay duration, and bleeding complications.

The research also addresses specific patient populations, including elderly patients aged 75 and older, and explores various administration methods from oral medications to catheter-directed therapies. The inclusion of imaging studies to assess lung function recovery demonstrates a commitment to understanding long-term outcomes following treatment. These trials collectively aim to refine treatment guidelines and provide more personalized care options for patients with pulmonary embolism.

Ongoing Clinical Trials on Pulmonary embolism

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

    Recruiting

    1 1 1
    Investigated drugs:
    France Norway
  • Study on the Effectiveness of Oxygen for Patients with Intermediate-Risk Acute Pulmonary Embolism

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain
  • Study on Monitoring vs. Rivaroxaban for Patients with Low-Risk Isolated Subsegmental Pulmonary Embolism

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France The Netherlands
  • Study on Lung Function After Pulmonary Embolism Using Galligas and 68Ga-MAA in Patients with Pulmonary Embolism

    Not yet recruiting

    1 1 1
    Investigated diseases:
    France
  • Study of Catheter-Directed Thrombolysis Using Alteplase for Treatment of Intermediate-High Risk Acute Pulmonary Embolism

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia
  • Study on Treatments for Intermediate High-Risk Pulmonary Embolism: Comparing Percutaneous Embolectomy, Ultrasound-Assisted Thrombolysis with Alteplase, and Heparin

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Denmark
  • Study on Reduced Dose of Alteplase for Patients with Intermediate-High-Risk Acute Pulmonary Embolism

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria France Germany Italy The Netherlands Poland +2
  • Study on Dabigatran, Apixaban, Rivaroxaban, and Edoxaban for Patients with Atrial Fibrillation, Deep Vein Thrombosis, or Pulmonary Embolism

    Not recruiting

    1 1 1 1
    Denmark
  • Study on Tinzaparin and Dalteparin for Patients with Venous Thromboembolism

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Denmark
  • Study on Pulmonary Embolism: Comparing Iomeprol Dosages in CT Scans for Patients with Suspected Pulmonary Embolism

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain