Ongoing Clinical Trials for Myocardial Infarction
There are currently 9 clinical trials investigating new treatments and approaches for patients who have experienced a myocardial infarction (heart attack). These studies are examining various medications and treatment strategies to improve outcomes, reduce complications, and enhance recovery after a heart attack. The trials are taking place across multiple European countries including Denmark, Sweden, Poland, Netherlands, Italy, Germany, Belgium, Czechia, Romania, Hungary, Spain, and Austria.
Clinical trial locations
- Austria
- Belgium
- Czechia
- Denmark
- Study on Reducing Bleeding Risk in Heart Attack Patients Using Clopidogrel, Ticagrelor, and Prasugrel After Stent Procedure
- Study on the Effect of Influenza Vaccine on Heart Inflammation After Heart Attack for Patients with Myocardial Infarction
- Study on the Effects of Carvedilol, Metoprolol Tartrate, and Bisoprolol Fumarate in Patients After a Heart Attack with Normal Heart Pumping Function
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Romania
- Spain
- Sweden
Study on Reducing Bleeding Risk in Heart Attack Patients Using Clopidogrel, Ticagrelor, and Prasugrel After Stent Procedure
This trial is examining a personalized treatment approach for patients who have experienced a heart attack and are at high risk of bleeding. The study focuses on dual antiplatelet therapy, which uses two medications to prevent blood clots.
Main inclusion criteria: Participants must be at least 18 years old and have had a Type 1 heart attack treated with percutaneous coronary intervention, a procedure that places a stent in the heart’s blood vessels. The heart attack must meet specific medical criteria including elevated cardiac troponin levels and symptoms such as chest pain or new ECG changes. Participants must have a PRECISE-DAPT score of 25 or higher, indicating elevated bleeding risk.
Main exclusion criteria: Patients cannot participate if they are unable to safely use a personalized treatment plan involving clopidogrel, cannot undergo genetic testing to assess how their body processes medications, or cannot have a shorter duration of dual antiplatelet therapy.
Study focus: The trial investigates whether patients at high risk of bleeding can safely switch to a personalized, less intense treatment strategy using clopidogrel with a shorter duration of dual antiplatelet therapy. This approach is guided by genetic testing called Cytochrome P2C19-genotyping. The goal is to reduce bleeding complications without increasing the risk of further heart problems.
Investigational drugs: The study examines clopidogrel, ticagrelor (Brilique), prasugrel (Efient and other brands), and acetylsalicylic acid (aspirin). These medications are taken orally as film-coated tablets and work by preventing blood clots.
Study on the Effect of Influenza Vaccine on Heart Inflammation After Heart Attack for Patients with Myocardial Infarction
This trial investigates whether the influenza vaccine can reduce heart inflammation following a heart attack. The study is conducted in Denmark and Sweden.
Main inclusion criteria: Participants must be male or non-fertile female subjects aged 18 years or older who have recently experienced a non-ST-segment elevation heart attack and completed a coronary PCI procedure. A special heart scan called CCTA must be scheduled within 7 days after the procedure. Participants must provide written informed consent.
Main exclusion criteria: Patients are excluded if they have bleeding disorders, are outside the specified age range, or belong to vulnerable populations requiring special protection.
Study focus: The trial compares the effects of the influenza vaccine VaxigripTetra with a placebo in reducing heart inflammation after a heart attack. Researchers will monitor changes in heart inflammation over eight weeks using computed tomography imaging. The study also measures various blood markers related to inflammation and heart health.
Investigational drugs: The study uses VaxigripTetra, an influenza vaccine containing inactivated strains of influenza virus, along with sodium chloride solution. The vaccine is administered as an intramuscular injection.
Study on the Effects of Ferric Carboxymaltose on Heart Health and Quality of Life in Patients with Recent Heart Attack and Iron Deficiency
This Polish trial examines the effects of iron replacement therapy in patients who have recently experienced a heart attack and also have iron deficiency.
Main inclusion criteria: Participants must be at least 18 years old and have had a recent heart attack (either STEMI or NSTEMI) within the last 4 weeks. They must have confirmed iron deficiency with transferrin saturation levels below 20%. Additionally, participants must have at least three of the following factors: heart function (LVEF) of 50% or less, elevated NT-proBNP levels, signs of fluid buildup requiring treatment, diabetes, atrial fibrillation, blockages in multiple heart arteries, incomplete treatment during the heart attack, history of previous heart attack, reduced kidney function, or age 70 years or older.
Main exclusion criteria: The trial excludes patients who have had a recent heart attack associated with iron deficiency but do not meet the other specific inclusion criteria.
Study focus: The study evaluates whether treating iron deficiency with ferric carboxymaltose can reduce the risk of death and heart failure events while improving quality of life. Participants will be monitored for up to 36 months, with researchers tracking heart failure events, changes in the NT-proBNP blood marker, and quality of life using the EQ-5D questionnaire.
Investigational drugs: Ferric carboxymaltose is administered intravenously with a 0.9% sodium chloride solution. This iron replacement therapy aims to replenish iron stores, which are essential for hemoglobin production and oxygen transport in the blood.
Study of Orticumab in Adults with Previous Heart Attack and High Coronary Inflammation Measured by CT Scan
This multinational trial, conducted across Poland, Czechia, Romania, Hungary, Italy, and Spain, investigates a new medication for patients with atherosclerotic cardiovascular disease who have previously experienced a heart attack and show signs of coronary artery inflammation.
Main inclusion criteria: Participants must be between 18 and 75 years old and at least 180 days past their heart attack. They must be on stable heart medications including cholesterol-lowering drugs, blood-thinning medications, and blood pressure medications. A special heart scan (CCTA) must show specific levels of inflammation around the heart arteries. Body mass index must be 40 or less. Women must not be pregnant or breastfeeding and must use effective birth control. Men must use appropriate contraception for 100 days after the last treatment.
Main exclusion criteria: The trial excludes patients who cannot undergo CCTA scans, have known allergies to orticumab, are currently participating in other trials, have severe allergic reactions to medications, have serious heart rhythm problems, severe kidney or liver disease, active cancer or recent cancer treatment, recent major surgery, uncontrolled high blood pressure, severe bleeding disorders, recent stroke, severe mental health conditions, or drug or alcohol abuse.
Study focus: The study tests orticumab given as an injection to determine its effects on reducing inflammation in coronary arteries. Inflammation is measured using the Fat Attenuation Index score through Coronary Computed Tomography Angiography. The treatment period lasts 6 months, during which participants undergo regular health checks, blood tests, and heart scans.
Investigational drugs: Orticumab is an investigational targeted immunotherapy administered through intravenous infusion. It works by modulating inflammatory processes in coronary arteries, specifically focusing on reducing inflammation as measured by coronary CT scans.
Study on Prasugrel and Acetylsalicylic Acid for Patients with ST-Elevated Myocardial Infarction Undergoing Different Revascularization Techniques
This trial, conducted across the Netherlands, Italy, Germany, Belgium, and Czechia, examines treatment strategies for patients with ST-Elevated Myocardial Infarction (STEMI), a severe type of heart attack.
Main inclusion criteria: Patients must have experienced STEMI with chest discomfort lasting 20 minutes or more at rest and showing specific ECG changes. Only the main problem area should be treated during the initial procedure for patients with narrowing in multiple heart arteries. Participants must provide informed consent and follow the dual antiplatelet therapy without changes. They should not have experienced major events like another heart attack, unplanned procedures, stent problems, stroke, or significant bleeding. The procedure to restore blood flow must be successful with less than 30% narrowing remaining.
Main exclusion criteria: Patients outside the specified age range, not part of the clinical trial groups, or belonging to vulnerable populations are excluded.
Study focus: The trial compares a new treatment plan starting with a combination of medications including prasugrel for a short period, followed by prasugrel alone, against standard treatment. The study also compares two methods of completing revascularization: Optical Coherence Tomography (OCT), which uses light waves, versus standard angiography using X-rays. The study will last about a year with follow-ups at 2, 11, and 35 months.
Investigational drugs: The study examines prasugrel and acetylsalicylic acid (aspirin), both taken orally. These antiplatelet medications work by preventing platelets from sticking together and forming blood clots.
Study on the Safety of Ticagrelor and Aspirin in Patients with ST-Elevation Myocardial Infarction After Heart Procedure
This Dutch trial investigates the safety of using ticagrelor alone versus ticagrelor combined with aspirin in patients who have experienced STEMI and undergone primary percutaneous coronary intervention.
Main inclusion criteria: Patients must have a clinical and electrocardiographical diagnosis of STEMI with specific ECG patterns. They must have undergone successful PCI of the affected vessel as determined by the treating physician and received a modern drug-eluting stent. Participants must be between 18 and 80 years old.
Main exclusion criteria: Patients who have not experienced STEMI, are outside the specified age range, belong to clinical trial groups not included in the study, or are part of vulnerable populations are excluded.
Study focus: The trial compares two treatment strategies over 12 months: ticagrelor alone versus ticagrelor plus aspirin. Researchers monitor the occurrence of heart-related events and the extent of bleeding within the heart muscle (intramyocardial hemorrhage) during the first week after the procedure. The study also assesses bleeding risk, overall survival, and how the medications affect blood clotting and inflammation.
Investigational drugs: The study uses ticagrelor and acetylsalicylic acid (aspirin), both administered orally as tablets. These medications help prevent blood clots by inhibiting platelet aggregation.
Study on Methylprednisolone and Sodium Chloride for Patients with Heart Attack (STEMI)
This trial investigates the effects of methylprednisolone treatment for patients experiencing ST-segment elevation myocardial infarction.
Main inclusion criteria: Participants must be 18 years or older, including women of childbearing age. They must have sudden chest pain that started less than 12 hours ago and have STEMI identified by specific ECG changes, such as 2 mm or more elevation in specific heart leads, new left bundle branch block with at least 1 mm elevation, 1 mV elevation in certain leads, or ST depression indicating a posterior heart attack.
Main exclusion criteria: The trial excludes patients with heart attacks other than the specific type being studied, allergies to the study medication, severe kidney or liver disease, pregnancy or breastfeeding, recent participation in other trials, uncontrolled high blood pressure, history of stroke or bleeding disorders, active infections or fever, or inability to give informed consent.
Study focus: The study examines whether administering 250 mg of methylprednisolone before hospital arrival can reduce the size of heart damage in STEMI patients. The medication is compared to a placebo, with the heart’s condition assessed three months after the initial event using cardiac magnetic resonance imaging. The study also monitors microvascular obstruction, hemorrhage in the heart, overall heart health, patient survival, and hospital visits for heart failure.
Investigational drugs: Methylprednisolone is a glucocorticoid (steroid) given as an intravenous infusion along with sodium chloride solution. It works by reducing inflammation and the body’s immune response.
Study on Prasugrel or Ticagrelor for Patients with Atrial Fibrillation and Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
This trial, conducted in Germany and Austria, focuses on patients with atrial fibrillation and acute coronary syndrome, including both STEMI and NSTEMI, who undergo percutaneous coronary intervention.
Main inclusion criteria: Participants must provide written informed consent, be at least 18 years old, have atrial fibrillation requiring oral anticoagulation treatment, and have experienced STEMI or NSTEMI. They must successfully complete PCI with adequate blood flow and be randomized into the study within 5 days, preferably within 24 hours, before hospital discharge.
Main exclusion criteria: The trial excludes patients with bleeding disorders, severe liver disease, history of stroke, uncontrolled high blood pressure, medications affecting blood clotting, allergies to study medications, pregnancy or breastfeeding, or other serious medical conditions that would make participation unsafe.
Study focus: The study explores whether using stronger antiplatelet medication (P2Y12-inhibitor like prasugrel or ticagrelor) for a short period of four weeks can reduce the risk of further heart-related issues without causing more bleeding problems. Participants receive either prasugrel or ticagrelor compared to other treatments including aspirin and clopidogrel. The study monitors heart-related events and bleeding issues over several weeks, with primary assessment at 6 weeks after randomization.
Investigational drugs: The trial examines prasugrel, ticagrelor, acetylsalicylic acid (aspirin), and clopidogrel, all administered orally. These antiplatelet medications work by preventing platelets from sticking together and forming blood clots.
Study on the Effects of Carvedilol, Metoprolol Tartrate, and Bisoprolol Fumarate in Patients After a Heart Attack with Normal Heart Pumping Function
This Danish trial studies the effects of beta-blocker medications in patients who have experienced a heart attack but do not have reduced ejection fraction, meaning their heart pumping function remains normal.
Main inclusion criteria: Participants must be 18 years or older with left ventricular ejection fraction greater than 40%. They must have had a diagnosed heart attack meeting specific criteria, including a rise or fall in heart-related blood markers along with at least one of the following: symptoms of reduced blood flow to the heart, new or significant ECG changes, development of pathological Q waves on the ECG, or imaging evidence showing new loss of heart muscle or abnormal heart wall movement.
Main exclusion criteria: Patients outside the specified age range, belonging to clinical trial groups not included in the study, or considered part of vulnerable populations are excluded.
Study focus: The trial investigates whether beta-blocker medications can help prevent further heart-related issues such as another heart attack, stroke, or heart failure. Participants are randomly assigned to receive carvedilol, metoprolol, bisoprolol, or nebivolol, or a placebo. The study lasts up to 77 days, during which participants take medication daily. The trial also examines quality of life, side effects, and effects on other conditions like chronic obstructive pulmonary disease or diabetes.
Investigational drugs: The study examines carvedilol, metoprolol tartrate, bisoprolol fumarate, and nebivolol hydrochloride, all taken orally as tablets. These beta-blockers work by slowing down the heart rate and reducing the heart’s workload, blocking the effects of adrenaline on the heart’s beta receptors.
Summary
The 9 ongoing clinical trials for patients who have experienced a heart attack reflect diverse therapeutic approaches addressing different aspects of post-heart attack care. Denmark leads in trial activity with three studies, followed by multiple countries hosting trials across various European locations.
A notable focus across several trials is the optimization of antiplatelet therapy, with studies examining medications such as clopidogrel, ticagrelor, and prasugrel. These trials aim to balance the need to prevent blood clots with the risk of bleeding complications, particularly in high-risk patients.
Several trials explore innovative approaches beyond traditional heart medications, including iron replacement therapy for patients with iron deficiency, the potential anti-inflammatory effects of the influenza vaccine, and targeted immunotherapy with orticumab to reduce coronary inflammation.
The trials also address specific patient populations, including those with atrial fibrillation requiring anticoagulation, patients with preserved heart function, and those at high risk of bleeding. The studies employ advanced imaging techniques such as cardiac magnetic resonance and coronary computed tomography angiography to assess treatment effects and guide personalized therapy.
Overall, these trials represent a comprehensive effort to improve outcomes for heart attack patients through personalized medicine approaches, novel therapeutic targets, and optimization of existing treatments.
