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Ongoing Clinical Trials for Cardiovascular Disorder

This article provides detailed information about 9 ongoing clinical trials investigating various treatments for cardiovascular disorders, including studies on vitamin C supplementation after heart surgery, medications to prevent stroke, treatments for heart inflammation following COVID-19, and therapies to lower cholesterol. These trials are being conducted across multiple European countries and evaluate both new experimental drugs and established medications for preventing and managing heart-related conditions.

Clinical trial locations

Study of Vitamin C (Ascorbic Acid) in Patients Undergoing Open-Heart Surgery to Reduce Post-Surgery Inflammation

This study is investigating the use of high-dose vitamin C to reduce inflammation following open-heart surgery. The trial is being conducted in Germany and focuses on patients requiring intensive care after cardiac procedures involving a heart-lung machine.

Who can participate: Adults aged 18 years or older who are scheduled for complex open-heart surgery are eligible. This includes patients undergoing combined valve surgery, coronary artery bypass grafting, multiple valve procedures, or combined cardiac and aortic operations. Participants must also have at least one additional risk factor, such as being over 70 years old, having a frailty score greater than 4, requiring urgent surgery within 24-48 hours, having reduced heart pumping capacity below 35%, or having a predicted mortality risk of 8% or higher based on the EuroSCORE II assessment tool.

Who cannot participate: People younger than 18 or older than 75 years are excluded. The study also excludes individuals with known allergies to vitamin C, severe kidney disease, recent heart attacks within the past three months, pregnancy or breastfeeding, organ transplants, blood clotting disorders, active cancer treatment, chronic inflammatory conditions, history of kidney stones, severe liver problems, or inability to provide informed consent. Those requiring emergency cardiac surgery or currently participating in other clinical trials are also excluded.

What the study involves: The trial examines whether vitamin C, given intravenously at doses calculated based on body weight, can help reduce the inflammatory response that commonly occurs after cardiac surgery. Participants will receive either vitamin C (brand name Pascorbin) or standard medical care for up to 7 days. The maximum daily dose is 200 mg per kilogram of body weight. Throughout the study, researchers will monitor heart function, recovery markers, and inflammatory indicators in the blood. Participants will be followed during their hospital stay and for several months afterward to assess their overall recovery and health status.

Study medication: Vitamin C is an essential nutrient and powerful antioxidant that helps protect cells from damage. In this trial, it is being studied for its potential to reduce inflammation and support the body’s natural healing processes following major heart surgery.

Study on Colchicine and Aspirin for Improving Heart Health in Adults with Type 2 Diabetes Without Previous Heart Events

This clinical trial is evaluating whether adding colchicine or aspirin to standard diabetes care can reduce heart-related problems in people with Type 2 diabetes who have not yet experienced cardiovascular events. The study is taking place across multiple countries including Italy, France, Greece, Finland, Portugal, and Denmark.

Who can participate: Men and women aged between 55 and 80 years with Type 2 diabetes being treated according to national guidelines are eligible. Participants must have no previous history of heart attacks or similar events. Additionally, they must meet at least one of several conditions indicating higher cardiovascular risk: having diabetes for 5 years or more, HbA1c levels of 8.0% or higher in the past 2 years, current smoking, elevated inflammation markers (hs-CRP greater than 2.0 mg/L), high coronary calcium scores (Agatston score greater than 100), high triglyceride levels despite treatment, high LDL or non-HDL cholesterol despite medication, high Apo-B levels, or low HDL cholesterol levels.

Who cannot participate: The study excludes anyone who has had previous heart-related events such as heart attacks or strokes, those with existing heart disease, individuals not diagnosed with Type 2 diabetes, patients not considered high-risk for heart problems, those unable to take the study medications, pregnant or breastfeeding women, people under 18 or over 75 years old, those with other serious medical conditions that might interfere with the study, and participants already enrolled in another clinical trial.

What the study involves: Participants will be randomly assigned to receive either the active medications or placebo tablets. The study medications include MIGOUTINE (colchicine) 0.5 mg as a film-coated tablet and non-enteric coated aspirin, both taken orally. Throughout the trial, which continues until December 2027, researchers will monitor participants for cardiovascular events including heart attacks, strokes, or hospitalization for angina. Regular follow-up visits will assess health status and changes in cognitive function using the MoCA score.

Study medications: Colchicine is being tested to see if it can help improve heart health by reducing inflammation, which may lower the risk of serious heart-related events. Aspirin, a common medication often used to reduce pain and inflammation, is being evaluated for its ability to prevent serious heart issues in this high-risk population by reducing blood clot formation.

Study on Milvexian for Preventing Stroke in Patients with Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

This major international trial is studying a new medication called Milvexian to see if it can prevent recurrent strokes in people who have recently experienced an acute ischemic stroke or a high-risk transient ischemic attack (TIA, often called a mini-stroke). The study is being conducted across 23 European countries.

Who can participate: Adults aged 40 years or older who have recently had an ischemic stroke or TIA are eligible. For stroke patients, the NIHSS score must be 7 or less, with either ongoing symptoms, visible brain damage on imaging, or prior treatment to dissolve or remove the blockage. For TIA patients, symptoms must have completely resolved with no brain damage visible on scans, and an ABCD2 score of 6 or more is required. Participants must be able to join the study within 48 hours of the event. If treated with clot-dissolving medication or a procedure to remove the blockage, at least 24 hours must pass before enrollment, with brain scans confirming no bleeding and safe blood test results. All participants must be on or planning to start low-dose antiplatelet treatment as per guidelines. Women of childbearing potential must use highly effective birth control methods.

Who cannot participate: The study excludes patients who have had recent major surgery, those with bleeding disorders, patients currently taking anticoagulant medications, individuals with severe liver disease, those with uncontrolled high blood pressure, pregnant or breastfeeding women, people with known allergies to the study medication, and those who have recently participated in another clinical trial.

What the study involves: Participants will receive either Milvexian or placebo as film-coated tablets taken by mouth. The study will be conducted alongside standard antiplatelet medications such as aspirin and clopidogrel. Researchers will monitor participants for the occurrence of ischemic strokes and other cardiovascular events. Regular assessments will continue until the study concludes in November 2026.

Study medication: Milvexian is a Factor XIa inhibitor that works by blocking a specific protein in the blood that plays a role in blood clot formation. By inhibiting this protein, Milvexian aims to reduce the risk of new clots forming that could lead to strokes, while potentially having less bleeding risk compared to traditional blood thinners.

Study on Protamine Sulfate to Reduce Neurological Events After Aortic Valve Implantation in Patients with Aortic Stenosis

This French study is examining whether using protamine sulfate after transcatheter aortic valve implantation (TAVI) can reduce complications such as bleeding, stroke, and other heart-related issues in patients with aortic stenosis, a condition where the heart valve becomes narrowed.

Who can participate: Men and women aged 18 years or older who are eligible for transfemoral TAVI (a procedure to replace a heart valve through a blood vessel in the leg) can participate. Eligibility is not restricted based on ongoing blood clot prevention treatment. Participants must provide written informed consent and be registered with the French social healthcare system.

Who cannot participate: Patients under 18 years old, those not eligible for transfemoral TAVI, and patients without medical insurance coverage cannot participate in this study.

What the study involves: Participants will be randomly assigned to receive either protamine sulfate or usual care after their TAVI procedure. Protamine sulfate is given as an intravenous injection to counteract the blood-thinning effects of heparin used during the procedure. The goal is to reduce bleeding and other complications during the hospital recovery period. Researchers will closely monitor participants for signs of bleeding, stroke, or other health issues throughout their hospital stay, with a final assessment conducted before discharge.

Study medication: Protamine sulfate works by neutralizing heparin, a blood thinner used during heart procedures. By stopping the blood-thinning effects of heparin after the procedure is complete, protamine sulfate helps reduce the risk of bleeding complications, stroke, or heart attack during the recovery period.

Study on the Effectiveness and Safety of Atorvastatin, Simvastatin, and Fluvastatin in Patients at Risk of Cardiovascular Disease

This Spanish trial is exploring whether using genetic testing to guide statin treatment can help reduce muscle-related side effects while maintaining the cholesterol-lowering benefits of these medications. The study involves several commonly prescribed statins including atorvastatin, simvastatin, pitavastatin, rosuvastatin, pravastatin, lovastatin, and fluvastatin.

Who can participate: Adults aged 18 years or older who are at risk of developing heart disease and are likely to be prescribed moderate to high doses of statins are eligible. Specific dose requirements include atorvastatin 40 mg or more daily, simvastatin 20 mg or more daily, pitavastatin 2 mg or more daily, rosuvastatin 40 mg or more daily, pravastatin 40 mg or more daily, lovastatin 40 mg or more daily, or fluvastatin 80 mg or more daily. Participants must not have previously had genetic testing for certain genes related to how the body processes statins (SCLO1B1, ABCG2, CYP2C9, CYP3A4, CYP3A5, and HMGCR). Women of childbearing potential must agree to use effective birth control during the study.

Who cannot participate: Patients who are not at risk of heart-related diseases and do not need high or moderate doses of statins, individuals outside the specified age range, and people who are part of vulnerable populations requiring special protection are excluded.

What the study involves: The trial uses a preemptive genotyping strategy, which means analyzing genes to predict how patients might respond to statins. Participants will be followed for 9 months during which researchers will track muscle symptoms, changes in cholesterol levels, and any adjustments needed in medication dosage. The study will also evaluate the cost-effectiveness of using genetic testing to guide statin treatment and explore new genetic markers that might predict treatment response or side effects. Participants will complete questionnaires about medication adherence and any pain experienced.

Study medications: Statins are medications that lower cholesterol levels by blocking a substance the body needs to make cholesterol. They work by inhibiting the enzyme HMG-CoA reductase in the liver, which is crucial for cholesterol production. This can help prevent heart disease and stroke by reducing the buildup of fatty deposits in arteries.

Study of Prednisolone and Losartan in patients with heart inflammation after COVID-19 infection

This study, conducted in Austria and Germany, is examining whether a combination of prednisolone (a steroid that reduces inflammation) and losartan (a medication that helps protect the heart) can improve heart function in patients who have developed heart inflammation following COVID-19 infection.

Who can participate: Adults aged 18 years or older who had a confirmed COVID-19 infection more than 4 weeks ago and continue to experience ongoing or new symptoms not present before infection (Post-acute COVID-19 Syndrome) are eligible. Participants must have evidence of heart inflammation on cardiovascular magnetic resonance imaging showing at least one of the following: increased T1 measurements, increased T2 measurements, signs of scarring in the heart muscle or surrounding tissue, or heart pumping function between 45-50%. Both men and women can participate, and all must be willing and able to follow study procedures.

Who cannot participate: The study excludes patients under 18 years old, those with active myocarditis not related to COVID-19, individuals with known allergies to the study medications, pregnant or breastfeeding women, people with severe kidney dysfunction (creatinine clearance less than 30 mL/min), those with active or chronic infections other than COVID-19, patients with metal implants that would interfere with cardiac imaging, individuals with severe heart rhythm abnormalities, those with a history of severe allergic reactions, current participants in other trials, people unable to provide informed consent, those with severe liver disease, patients who have had a recent heart attack or stroke within the last 3 months, individuals with uncontrolled high blood pressure, and those with active cancer or ongoing cancer treatment.

What the study involves: An initial cardiovascular magnetic resonance scan will confirm heart inflammation related to COVID-19 and measure heart function. Participants will then receive either active treatment with prednisolone tablets (starting with 10 mg, then 5 mg) and losartan tablets (starting with 12.5 mg, increasing to 25 mg), or placebo tablets. Neither participants nor their doctors will know which treatment is being received. The treatment will continue for 16 weeks, during which participants must take medication as prescribed and keep a diary. After 16 weeks, another scan will measure changes in the heart, along with additional tests including exercise capacity, heart muscle measurements, and symptom assessment. Long-term health monitoring will continue for up to one year after treatment completion.

Study medications: The specific medications used in this trial are not detailed in the provided information, though the trial title indicates it involves prednisolone and losartan as part of a combined immunosuppressive and antiremodeling therapy approach for COVID-19-related cardiovascular inflammation.

Study on Long-Term Effects of Lerodalcibep for Lowering Cholesterol in Patients with Familial Hypercholesterolemia or Cardiovascular Disease Risks

This international study, conducted in Norway, Germany, France, and Spain, is investigating the long-term safety and effectiveness of an experimental drug called Lerodalcibep (LIB003) for lowering cholesterol in patients with inherited forms of high cholesterol or those at high cardiovascular risk.

Who can participate: Patients who have already completed a previous Phase 3 study with LIB003 without experiencing serious adverse events are eligible. Participants must provide written informed consent before any study procedures begin. Female participants of childbearing potential must use highly effective birth control if sexually active and have a negative pregnancy test before starting. Highly effective methods include birth control pills, patches, intrauterine devices, or having a partner who has had a vasectomy. Male participants must either be surgically sterile or agree to use contraception if their partner can have children, including condoms with spermicide or having a partner using effective contraceptives. Male participants must also agree not to donate sperm until 90 days after the last dose. All participants must be willing to maintain a proper diet and continue their current lipid-lowering therapy, which may include medications like statins and ezetimibe. Some patients may also need apheresis (a procedure to remove cholesterol from the blood) after 12 weeks. Participants must be considered otherwise healthy based on medical history, physical examination, vital signs, heart tests, and laboratory results.

Who cannot participate: The study excludes patients who have not completed a previous LIB003 Phase 3 study, those not on stable diet and maximally tolerated cholesterol-lowering therapy, individuals not at very-high or high risk for cardiovascular disease, those without Homozygous or Heterozygous Familial Hypercholesterolemia, patients outside the specified age range, and members of vulnerable populations not included in the study.

What the study involves: Participants receive LIB003 as a solution injected under the skin at a dose of 300 mg every four weeks for a total duration of 72 weeks. Throughout the study, regular assessments monitor the drug’s effectiveness and safety, including measuring changes in cholesterol levels and other blood fats at weeks 48 and 72. The study also monitors for any adverse effects and measures the presence of antibodies against LIB003 and the drug concentration in the blood.

Study medication: Lerodalcibep (LIB003) is a lipid-lowering agent administered through subcutaneous injection once monthly. It works by inhibiting a specific protein involved in cholesterol regulation, helping to further reduce LDL cholesterol levels in patients already taking stable lipid-lowering therapy.

Study on the Effects of Retatrutide for Patients with Severe Obesity and Cardiovascular Disease

This clinical trial, taking place in Poland, Spain, Slovakia, and Hungary, is evaluating a medication called Retatrutide for people with both severe obesity and established heart disease. The study aims to understand how this treatment can help manage weight and improve health outcomes in this high-risk population.

Who can participate: Both men and women with obesity and established heart disease who have a history of unsuccessful attempts to lose weight through diet are eligible. The study is open to participants from vulnerable populations who might need extra protection or care.

Who cannot participate: Patients with medical conditions other than cardiovascular disease or obesity, those outside the specified age range for the study, and members of vulnerable populations not included in the study cannot participate.

What the study involves: Upon joining, participants will be randomly assigned to receive either Retatrutide or a placebo injection. The medication is given as a subcutaneous injection (under the skin) once a week. Throughout the study, participants’ health will be monitored regularly to assess changes in body weight and overall health condition. Regular follow-up visits will be scheduled until the study concludes in February 2026.

Study medication: Retatrutide is designed to help reduce body weight by affecting certain hormones in the body that regulate appetite and metabolism. The medication influences metabolic processes that may help people lose weight and potentially improve heart health in those with both severe obesity and cardiovascular disease.

Study on Vascular Dysfunction: Comparing Acetylcholine Chloride and Carbachol for Forearm Blood Flow Evaluation in Patients

This Danish study is comparing two substances, acetylcholine chloride and carbachol, to see which is more effective for measuring blood flow in the forearm. The research aims to better understand vascular function and potentially improve how doctors assess blood vessel health.

Who can participate: Healthy men and women aged between 18 and 40 years with a Body Mass Index between 18.5 and 30 kg/m² are eligible. Women of childbearing potential must use contraceptive treatment to prevent pregnancy during the study.

Who cannot participate: Patients with vascular dysfunction (problems with blood vessels) cannot participate in this study.

What the study involves: During an initial visit, eligibility will be confirmed and participants will be informed about the study’s purpose of assessing blood flow measurement methods. Participants will receive an intraocular instillation solution containing either carbachol or acetylcholine chloride, administered directly to the eye. Following medication administration, forearm blood flow will be monitored using plethysmography, a non-invasive method that measures changes in volume. This involves measuring both relative and absolute blood flow to compare the effectiveness of the two substances. Follow-up visits may be required to monitor any changes or effects, and participants will be informed of findings upon study completion in May 2025.

Study medications: Acetylcholine and carbachol both work by causing blood vessels to widen, which increases blood flow. Both substances bind to receptors on blood vessels, triggering vasodilation. The study aims to determine if carbachol is as effective as acetylcholine in evaluating blood flow in the forearm.

Summary

These 9 ongoing clinical trials represent a diverse range of approaches to preventing and treating cardiovascular disorders across Europe. Several notable patterns emerge from this collection of studies.

Geographically, there is significant concentration of trials in Western and Central European countries. France, Germany, and Spain each host multiple trials, while the study on stroke prevention with Milvexian has the broadest reach, spanning 23 countries across Europe. This wide distribution suggests strong international collaboration in cardiovascular research.

The trials cover several key therapeutic areas within cardiovascular medicine. Multiple studies focus on stroke prevention, including the large international Milvexian trial and investigations into antiplatelet therapies for diabetes patients. Cholesterol management features prominently, with trials examining both genetic approaches to statin therapy and novel cholesterol-lowering agents like Lerodalcibep. The emerging relationship between COVID-19 and cardiovascular complications is addressed through research on heart inflammation treatments.

Several trials are exploring ways to reduce inflammation, whether through vitamin C supplementation after heart surgery, colchicine for diabetes patients, or corticosteroids for post-COVID heart inflammation. This reflects growing recognition of inflammation’s role in cardiovascular disease development and progression.

The trials also demonstrate different research approaches, from studying well-established medications like statins and aspirin in new contexts, to investigating completely novel therapeutic agents. Some studies are examining procedural improvements, such as the use of protamine sulfate to reduce complications after valve replacement procedures.

Importantly, several trials specifically target high-risk populations, including patients with genetic forms of high cholesterol, those with diabetes, and individuals with both obesity and established heart disease. This focus on prevention in vulnerable groups could potentially reduce the burden of cardiovascular events in these populations.

Ongoing Clinical Trials on Cardiovascular disorder

  • Study of vicadrostat and empagliflozin combination in patients with type 2 diabetes, high blood pressure and cardiovascular disease

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Croatia Czechia Denmark +17

  • Study of Zilebesiran Added to Standard Treatment to Reduce Heart Problems in Adults with High Blood Pressure and Heart Disease Risk

    Recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Czechia Denmark France +11

  • Study Comparing Buckberg and Del Nido Solutions for Heart Surgery in Patients with Cardiovascular Disease

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on Esmolol for Heart Issues in Patients with Cirrhosis, Diabetes, or Cardiotoxic Treatment

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • A study testing cagrilintide and semaglutide for heart safety in people with cardiovascular disease

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Denmark France Germany Ireland Italy +3

  • Study on Vascular Dysfunction: Comparing Acetylcholine Chloride and Carbachol for Forearm Blood Flow Evaluation in Patients

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on the Effectiveness and Safety of Atorvastatin, Simvastatin, and Fluvastatin in Patients at Risk of Cardiovascular Disease

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study on the Effects of Retatrutide for Patients with Severe Obesity and Cardiovascular Disease

    Not recruiting

    3 1
    Investigated diseases:
    Investigated drugs:
    Hungary Poland Slovakia Spain

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