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Arteriosclerosis – Trials in Disease

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Clinical Trials for Arteriosclerosis: Current Research and Treatment Studies

There are currently 23 ongoing clinical trials investigating new treatments and approaches for arteriosclerosis and related cardiovascular conditions. These studies are testing various medications designed to reduce cholesterol levels, prevent blood clots, lower inflammation, and decrease the risk of heart attacks and strokes. The trials are taking place across multiple countries in Europe and involve patients at different stages of cardiovascular disease, from those at high risk to those with established disease.

Clinical trial locations

Long-term Safety Study of INZ-701 for Patients with ENPP1 and ABCC6 Deficiencies, Including Pseudoxanthoma Elasticum and Generalized Arterial Calcification of Infancy

This trial is designed for patients with rare genetic conditions that affect calcium regulation in the body, specifically ENPP1 and ABCC6 deficiencies. These conditions can lead to serious problems with the skin, eyes, and blood vessels due to abnormal calcium buildup.

Main inclusion criteria: Participants must be over one year old and have successfully completed a previous INZ-701 study for these conditions. They need to provide informed consent and agree to use appropriate birth control methods if applicable. The study doctor must confirm that they can complete all study activities.

Main exclusion criteria: The study specifically excludes patients with Pseudoxanthoma Elasticum, Generalized Arterial Calcification of Infancy, ENPP1 Deficiency, and ABCC6 Deficiency who have not completed the prior required study.

Trial focus: The study monitors the long-term safety of INZ-701, administered as subcutaneous injections. Researchers will track any adverse events, conduct regular laboratory tests, and measure changes in blood levels of the medication and certain biochemical markers. The goal is to ensure the treatment remains safe over extended use.

Investigational drug: INZ-701 is a specially designed protein medication delivered through subcutaneous injection. It aims to help manage these rare genetic disorders by addressing the underlying enzyme deficiencies that cause abnormal calcium deposition in tissues.

Study of laroprovstat (AZD0780) to reduce heart attack, stroke and vascular complications in patients with atherosclerotic cardiovascular disease or high risk of developing it

This trial tests whether AZD0780 can reduce serious cardiovascular events in people with existing heart disease or those at high risk. The medication is taken as a tablet by mouth and is being compared to placebo.

Main inclusion criteria: Participants must be at least 18 years old with cholesterol levels of at least 60 mg/dL. They need either recent history of heart problems, stroke, or leg artery surgery (within 1-12 months), or evidence of blood vessel disease with additional risk factors like Type 2 diabetes or age 65 or older. All participants must be taking cholesterol-lowering medications at the highest tolerated dose for at least 28 days.

Main exclusion criteria: The trial excludes people with history of bleeding in the brain, severe liver disease, active bleeding disorders, major bleeding in the past 6 months, planned surgery, uncontrolled high blood pressure, severe kidney disease requiring dialysis, life expectancy less than 2 years, or conditions that could interfere with study participation.

Trial focus: Researchers will monitor participants for major cardiovascular events including heart attacks, strokes, severe leg circulation problems, and emergency procedures to restore blood flow. The study continues until October 2029, tracking whether AZD0780 helps prevent these serious complications.

Investigational drug: AZD0780 is a novel medication being tested for its potential to reduce major adverse cardiovascular events in high-risk patients by preventing serious heart and blood vessel complications.

Study of maridebart cafraglutide to reduce cardiovascular problems in overweight or obese patients with atherosclerotic cardiovascular disease

This study examines whether maridebart cafraglutide can help reduce heart-related problems in people who have both cardiovascular disease and weight issues. The medication is given as an injection under the skin.

Main inclusion criteria: Participants must be 45 years or older with a body mass index of 27 or higher. They need a history of heart disease including at least one of these: previous heart attack, previous stroke, or symptoms of peripheral arterial disease such as leg pain while walking, previous leg artery surgery, or amputation due to blocked arteries.

Main exclusion criteria: The trial excludes people with severe allergic reactions to similar medications, participation in other clinical trials within 30 days, uncontrolled diabetes, severe kidney disease requiring dialysis, severe liver problems, active pancreatic disease, active cancer or cancer treatment within 5 years, history of major stomach or intestinal surgery, unstable heart conditions, mental health conditions that could interfere with participation, current substance abuse, and pregnancy or breastfeeding.

Trial focus: The study tracks major heart-related events such as heart attacks, strokes, and need for heart procedures while participants continue their regular heart medications. Researchers monitor whether the treatment can lower the risk of serious cardiovascular outcomes and improve survival rates.

Investigational drug: Maridebart cafraglutide is a GLP-1 receptor agonist given by injection that works by regulating blood sugar levels, reducing appetite, and potentially providing cardiovascular benefits for patients with both heart disease and weight management needs.

Study on Clazakizumab for Heart Disease in Adults with End-Stage Kidney Disease on Dialysis

This trial studies how Clazakizumab affects inflammation and heart health in patients with end-stage kidney disease who are on dialysis. Inflammation is common in these patients and can lead to heart problems.

Main inclusion criteria: Participants must be at least 18 years old with diagnosed end-stage kidney disease and undergoing maintenance dialysis for at least 12 weeks. They need blood test results showing inflammation markers (hs-CRP) of 2.0 mg/L or higher. They must also have either diabetes mellitus or atherosclerotic cardiovascular disease.

Main exclusion criteria: The study excludes patients who do not have both atherosclerotic cardiovascular disease and end-stage kidney disease requiring dialysis, those outside the specified age range, and members of vulnerable populations who cannot provide informed consent.

Trial focus: The study evaluates whether Clazakizumab, given as an intravenous infusion, can reduce inflammation markers and improve cardiovascular outcomes. Researchers monitor changes in hs-CRP levels and track cardiovascular events such as heart attacks over up to 53 weeks.

Investigational drug: Clazakizumab is an anti-inflammatory medication administered through intravenous infusion that blocks a specific protein involved in inflammation, potentially reducing inflammation and improving heart health in dialysis patients.

Study on Colchicine and Ticagrelor for Preventing Ischemic Stroke in Patients with Atherosclerosis

This French trial tests whether low-dose colchicine and ticagrelor can help prevent recurrent strokes and heart problems in patients who have had an ischemic stroke or related conditions.

Main inclusion criteria: Participants must be at least 18 years old and have had a documented cerebral infarction, transient ischemic attack lasting 10 minutes or more, or documented atherosclerotic narrowing in certain arteries confirmed by imaging. They need a Rankin score less than 4, meaning they can manage most daily activities with some help. Women of childbearing age must use effective birth control. They must also need long-term antiplatelet therapy and have a social security number.

Main exclusion criteria: The study excludes patients with history of bleeding in the brain (hemorrhagic stroke), severe liver disease, active bleeding disorders, major bleeding in past 6 months, planned major surgery, uncontrolled high blood pressure, severe kidney disease requiring dialysis, life expectancy less than 2 years, drug or alcohol abuse within the past year, pregnancy or planned pregnancy, allergies to similar medications, inability to provide informed consent, mental conditions affecting participation, and history of non-compliance with treatments.

Trial focus: Participants take colchicine and ticagrelor orally for 36 to 60 months. The study monitors for recurrent strokes, heart attacks, and other major vascular events. Regular assessments track plaque volume in arteries and evaluate the relationship between blood clotting, inflammation, and cardiovascular outcomes.

Investigational drugs: Colchicine is an anti-inflammatory medication that works by inhibiting certain cellular processes to reduce inflammation. Ticagrelor is an antiplatelet medication that prevents blood clots by stopping platelets from sticking together, helping reduce stroke risk in high-risk patients.

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

This French study compares different approaches to preventing blood clots in patients with acute venous thromboembolism who are already taking medications for other heart conditions.

Main inclusion criteria: Patients must have an acute venous thromboembolism event with confirmed proximal deep-vein thrombosis or pulmonary embolism. They need to be prescribed full-dose anticoagulant therapy for at least 3 months and must already be taking antiplatelet therapy for preventing heart and blood vessel diseases at the time of diagnosis.

Main exclusion criteria: The study excludes patients who have had a recent acute venous thromboembolism event, those currently taking antiplatelet therapy, patients outside the specified age range, and those who are part of vulnerable populations.

Trial focus: The trial compares using full-dose anticoagulant therapy alone versus combining it with antiplatelet therapy. Participants are monitored for up to 12 months to assess bleeding risks and effectiveness. The study aims to determine the safest and most effective treatment approach for patients with blood clots who also need antiplatelet medications.

Investigational drugs: The trial uses various anticoagulant medications (including tinzaparin sodium, warfarin, apixaban, and others) to prevent blood clots, comparing their safety and effectiveness when used alone versus in combination with antiplatelet medications that prevent platelets from forming clots.

Study on the Effects of Obicetrapib and Ezetimibe on Coronary Plaque in Patients with Atherosclerotic Cardiovascular Disease

This trial examines how a combination of obicetrapib and ezetimibe affects fatty deposits (plaques) in the coronary arteries of people with heart disease.

Main inclusion criteria: Participants must be willing to provide informed consent and follow all procedures. They need a body mass index between 18 and 40 kg/m², be 45 years or older, and have evidence of atherosclerotic cardiovascular disease shown by medical tests or history. They must have specific types of plaque in heart arteries visible on special scans, be taking cholesterol-lowering medications (especially statins), have fasting LDL cholesterol of 70 mg/dL or higher, fasting triglycerides less than 400 mg/dL, and kidney function (GFR) of 40 mL/min/1.73 m² or higher. Women must not be pregnant or breastfeeding and must use effective birth control.

Main exclusion criteria: The trial excludes people with serious health conditions that might interfere, those who are pregnant or breastfeeding, recent heart attack or stroke, severe liver or kidney disease, current participation in another trial, allergies to study medications, history of substance abuse, inability to follow procedures, or conditions making participation unsafe.

Trial focus: Participants receive either the obicetrapib-ezetimibe combination or placebo for 18 months. Regular coronary CT angiography scans measure changes in plaque volume, while blood tests track cholesterol levels and other health indicators. The study evaluates whether this combination can reduce non-calcified plaque buildup in coronary arteries.

Investigational drugs: Obicetrapib is a cholesterol ester transfer protein inhibitor that works by affecting cholesterol transport to help lower cholesterol levels and reduce plaque. Ezetimibe is a cholesterol absorption inhibitor that reduces cholesterol absorption in the intestines, helping decrease blood cholesterol levels.

Long-term safety study of pelacarsen in patients with atherosclerotic cardiovascular disease who completed the Lp(a)HORIZON trial

This extension study evaluates the long-term safety of pelacarsen in patients with high lipoprotein(a) levels and established cardiovascular disease who completed a previous trial.

Main inclusion criteria: Participants must be between 18 and 85 years old, provide informed consent before any procedures, have completed the previous Lp(a)HORIZON study while still taking the medication, have established cardiovascular disease, and have elevated Lp(a) levels in their blood.

Main exclusion criteria: The study excludes people with history of severe allergic reactions to similar medications, active chronic inflammatory conditions, significant kidney problems (GFR below 30 mL/min/1.73m²), uncontrolled high blood pressure, major bleeding within past 12 months, active liver disease, pregnancy or breastfeeding, unsafe conditions for participation, inability to comply with procedures, participation in other trials within 30 days, current substance abuse, or life expectancy less than study duration.

Trial focus: Participants receive pelacarsen as subcutaneous injections throughout the study period until 2029. Regular check-ups monitor safety, track adverse events, measure Lp(a) levels, and evaluate cardiovascular health. The study aims to confirm the medication remains safe over extended use.

Investigational drug: Pelacarsen is an antisense oligonucleotide that works by reducing production of lipoprotein(a) in the liver, helping lower blood levels of this risk factor for cardiovascular disease in patients with elevated Lp(a) and established heart disease.

Study of Olpasiran to prevent first major cardiovascular events in people with high levels of lipoprotein(a)

This study tests whether olpasiran can prevent first-time major heart events in people with high lipoprotein(a) levels who have never experienced them before.

Main inclusion criteria: Participants must be 50 years or older, able to provide written informed consent, have lipoprotein(a) levels of 200 nmol/L or higher measured at screening, be on stable lipid-lowering therapy for at least 4 weeks, and meet at least one of these: multiple risk factors for heart disease or history of plaque buildup in arteries.

Main exclusion criteria: The trial excludes people with history of heart attack or coronary procedures, those taking medications that significantly affect blood lipids, severe kidney disease or dialysis, uncontrolled high blood pressure (above 160/100), bleeding disorders or significant bleeding in past 6 months, active liver disease, current participation in other trials or within past 30 days, known allergies to similar medications, pregnancy or planned pregnancy, substance abuse within past year, and conditions making participation unsafe.

Trial focus: Participants are randomly assigned to receive either olpasiran or placebo while continuing their current heart medications. The study monitors for major cardiovascular events including heart attacks, strokes, and need for urgent heart procedures until 2031. Regular assessments track lipoprotein(a) levels and overall heart health.

Investigational drug: Olpasiran is a small interfering RNA therapeutic administered by subcutaneous injection that works by blocking messenger RNA in the liver to reduce production of lipoprotein(a), lowering blood levels of this cardiovascular risk factor.

Study of pelacarsen and inclisiran in patients with atherosclerotic cardiovascular disease who have high levels of LDL cholesterol and lipoprotein(a)

This trial tests whether pelacarsen, when combined with inclisiran, can effectively reduce lipoprotein(a) levels in patients with heart disease who also have high LDL cholesterol.

Main inclusion criteria: Participants must be between 18 and 80 years old with confirmed atherosclerotic cardiovascular disease (including coronary heart disease, cerebrovascular disease, or peripheral arterial disease). They need to be taking stable cholesterol-lowering medications for at least 30 days, complete a trial period with inclisiran, be on standard treatments for other heart conditions for at least 30 days, have lipoprotein(a) levels of 175 nmol/L or higher, and LDL cholesterol above 70 mg/dL at screening.

Main exclusion criteria: The study excludes people below 18 or above 80 years, those with allergies to study medications, history of severe allergic reactions, pregnancy or breastfeeding, active liver disease, severe kidney disease, uncontrolled high blood pressure (above 160/100 mmHg), recent heart attack or stroke (within 3 months), major surgery within 3 months, current participation in other trials, inability to provide consent, bleeding disorders or use of blood thinners, active cancer or cancer treatment within 5 years, and unstable heart conditions.

Trial focus: After completing an initial inclisiran treatment period, participants are randomly assigned to receive either pelacarsen or placebo, while continuing inclisiran. The study evaluates whether this combination can reduce Lp(a) levels below 125 nmol/L at 6 months, with ongoing monitoring for safety and effectiveness until September 2028.

Investigational drugs: Pelacarsen is an antisense oligonucleotide that reduces lipoprotein(a) production by targeting specific proteins in the liver. Inclisiran is a small interfering RNA medication that lowers LDL cholesterol by helping the liver remove more of it from the bloodstream, given twice yearly after initial doses.

Study on Aspirin’s Effect on Platelet Aggregation in Patients with Type 1 Diabetes, Atherosclerotic Cardiovascular Disease, and Diabetic Kidney Disease

This Danish study examines how aspirin affects blood clotting in people with Type 1 diabetes and its relationship to heart and kidney health.

Main inclusion criteria: Participants must have Type 1 diabetes, be male or female older than 18 years, and be capable of giving informed consent.

Main exclusion criteria: The study excludes patients with atherosclerotic cardiovascular disease (narrowed or blocked blood vessels due to cholesterol buildup), Type 1 diabetes, or diabetic kidney disease (where diabetes affects kidney function).

Trial focus: The study measures how platelets clump together before and after aspirin treatment, which lasts at least seven days. It examines the presence of fatty deposits in arteries and their relationship to blood clotting in people with diabetes. Regular assessments track plaque volume, kidney function (measured by albumin in urine), and inflammation markers.

Investigational drug: Aspirin is a nonsteroidal anti-inflammatory drug and antiplatelet agent taken orally in tablet form. It works by inhibiting an enzyme that reduces production of substances promoting inflammation and blood clotting, helping prevent platelets from clumping together.

Summary

The 23 ongoing clinical trials for arteriosclerosis demonstrate a strong focus on preventing cardiovascular events through various therapeutic approaches. Several key observations emerge from this research landscape:

Many trials concentrate on lipid management, particularly targeting elevated lipoprotein(a) levels with medications like pelacarsen, olpasiran, and inclisiran. Multiple studies are testing these drugs either alone or in combination to reduce cholesterol and prevent heart attacks and strokes.

Geographically, there is notable concentration of trials in Central and Western European countries, with Germany, Poland, Italy, Spain, France, and the Netherlands hosting the most studies. Several trials are also taking place in Nordic countries including Sweden, Denmark, Norway, and Finland.

The research spans different patient populations, from those at high risk who have not yet experienced cardiovascular events to those with established disease. Several trials specifically address patients with additional complications such as kidney disease requiring dialysis, Type 1 diabetes, or obesity.

The investigational approaches vary widely, including cholesterol-lowering medications, anti-inflammatory drugs, antiplatelet therapies, and novel RNA-based treatments. Many studies employ subcutaneous injection delivery methods, though oral medications are also being tested.

Study durations range from months to several years, with some extending to 2029 or beyond, reflecting the long-term nature of cardiovascular disease management and the need for extended safety monitoring.

Ongoing Clinical Trials on Arteriosclerosis

  • A study to evaluate the effect of orforglipron on cardiovascular health in adults with atherosclerotic cardiovascular disease and/or chronic kidney disease

    Recruiting

    1 1
    Investigated diseases:
    Austria Belgium Bulgaria Czechia Estonia France +10

  • A study of ziltivekimab compared to placebo in people with heart and blood vessel disease, chronic kidney disease and inflammation

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Croatia Czechia Denmark Germany +12

  • A study to evaluate the effect of muvalaplin on reducing major cardiovascular events in adults with high levels of lipoprotein(a) and atherosclerotic cardiovascular disease.

    Not recruiting

    1 1
    Investigated diseases:
    Austria Belgium Czechia Denmark France Germany +8

  • Investigating Lepodisiran for Reducing Cardiovascular Events in Adults with Elevated Lipoprotein(a) and Atherosclerotic Cardiovascular Disease or at Risk for a First Cardiovascular Event

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Czechia Denmark France Germany +8

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