Ongoing Clinical Trials for Acute Coronary Syndrome
Acute coronary syndrome is a serious heart condition that occurs when blood flow to the heart is suddenly blocked. Currently, 14 clinical trials are investigating new treatment approaches to improve outcomes and reduce complications for patients with this condition. These studies are testing various medications and treatment strategies, including different blood-thinning medications, drug-coated devices, and combination therapies.
Clinical trial locations
- Austria
- Belgium
- Study on Reducing Bleeding by Omitting Aspirin in Patients with Non-ST Elevation Acute Coronary Syndrome
- Study on the Effects of Ticagrelor and Rivaroxaban in Patients with Atrial Fibrillation After Coronary Stent Surgery
- Study Comparing Single and Dual Antiplatelet Therapy with Clopidogrel and Acetylsalicylic Acid in Elderly Patients or Those at Risk of Bleeding After Balloon Surgery
- Study on Milvexian and Drug Combination for Patients Recovering from a Heart Attack
- Bulgaria
- Croatia
- Czechia
- Denmark
- Estonia
- Finland
- France
- Study on the Effects of Ticagrelor and Rivaroxaban in Patients with Atrial Fibrillation After Coronary Stent Surgery
- Study on Monitoring Anticoagulant Therapy with Rivaroxaban and Warfarin in Patients with Acute Coronary Syndrome and Atrial Fibrillation
- Study on Milvexian and Drug Combination for Patients Recovering from a Heart Attack
- Germany
Study on Dabigatran and Ticagrelor for Patients with Acute Coronary Syndrome and Atrial Fibrillation Undergoing Heart Procedure
This trial is taking place in Poland and focuses on patients who have both acute coronary syndrome and a condition called atrial fibrillation, which is an irregular heartbeat. The study is for people who have undergone a procedure to open blocked heart arteries using a stent.
Who can participate: Patients aged 18 to 99 years with non-valvular atrial fibrillation who have had successful stent placement within the last 120 hours are eligible. Participants must be taking dabigatran or be ready to start it before the procedure. The irregular heartbeat should not be caused by temporary issues like recent surgery or thyroid problems.
Who cannot participate: People with a history of severe allergic reactions to the study medications, active bleeding, severe liver disease, recent stroke or brain injury, pregnant or breastfeeding women, severe kidney problems, those currently in another trial, recent heart attack or heart surgery, uncontrolled high blood pressure, or other conditions that doctors believe would make participation unsafe are excluded.
What the study is testing: The trial compares two treatment approaches. One group receives a combination of reduced-dose ticagrelor and standard-dose dabigatran. The other group receives triple therapy with clopidogrel, aspirin, and dabigatran. The goal is to see which approach better balances preventing blood clots while reducing bleeding risk.
Medications involved: Dabigatran prevents blood clots by thinning the blood. Ticagrelor and clopidogrel stop platelets from sticking together, while aspirin has similar antiplatelet properties and also reduces pain and inflammation.
Study on Dexamethasone and Olanzapine for Patients Undergoing Heart Surgery
This study in Denmark is examining medications that may help patients recover better after heart surgery, specifically coronary artery bypass grafting or heart valve replacement.
Who can participate: Adults over 18 years old who are scheduled for coronary artery bypass grafting or aortic valve replacement surgery are eligible, regardless of whether other valve surgeries are happening at the same time.
Who cannot participate: People not undergoing these specific heart surgeries, those outside the specified age range, and vulnerable populations requiring special protection are excluded.
What the study is testing: The trial examines whether dexamethasone, a steroid that reduces inflammation, and olanzapine, typically used for mental health conditions, can improve recovery after heart surgery. The study will track how many days patients are alive and out of the hospital within 90 days after surgery, along with complications like stroke, kidney injury, or heart failure.
Medications involved: Dexamethasone is given by injection to reduce inflammation. Olanzapine is given as a tablet that dissolves in the mouth before surgery. The study also examines different methods of managing blood flow and breathing during surgery.
Study on Milvexian and Drug Combination for Patients Recovering from a Heart Attack
This large international trial is being conducted across 20 European countries, including Croatia, Slovakia, Germany, Hungary, Belgium, Romania, Austria, Portugal, Italy, Czechia, Bulgaria, Poland, Lithuania, Greece, France, Netherlands, Spain, Estonia, Denmark, and Latvia. It focuses on patients who have recently experienced an acute coronary syndrome.
Who can participate: Patients must have had an acute coronary syndrome within the last 7 days, including sudden onset with increased heart-related substances in the blood. They must also have at least two risk factors such as being 65 or older, having diabetes, previous heart attack, disease in multiple heart arteries, previous heart surgery, blood vessel disease elsewhere, or certain high-risk features in their heart arteries. Women who can become pregnant must have a negative pregnancy test.
Who cannot participate: People with recent heart attack or stroke, bleeding disorders, those taking other blood thinners, severe liver or kidney disease, pregnant or breastfeeding women, known allergies to the study medication, or those who participated in another trial within the last 30 days are excluded.
What the study is testing: The trial evaluates whether milvexian, a new medication taken by mouth, can reduce the risk of serious heart-related events when added to usual care. Participants will be randomly assigned to receive either milvexian or a placebo alongside their regular heart medications for up to 48 weeks.
Medications involved: Milvexian works by blocking a protein called Factor XIa that is involved in blood clot formation. Other medications in the study include prasugrel, aspirin, ticagrelor, and clopidogrel, all of which help prevent blood clots.
Study on Reducing Antiplatelet Therapy in Patients with Acute Coronary Syndrome and High Bleeding Risk Using Prasugrel, Ticagrelor, or Clopidogrel
This Italian trial studies patients with acute coronary syndrome who have undergone stent placement and are at high risk of bleeding.
Who can participate: Patients must have signed consent and be at high bleeding risk based on specific scoring systems. They must have been treated with stent placement due to acute coronary syndrome within the last 30 days and be taking full-dose antiplatelet therapy with prasugrel or ticagrelor.
Who cannot participate: Those with previous acute coronary syndrome, outside the specified age range, or part of vulnerable populations are excluded.
What the study is testing: The trial compares lower doses of antiplatelet medications to find the best balance between preventing blood clots and reducing bleeding risk. Patients are randomly assigned to receive reduced doses of prasugrel, ticagrelor, or clopidogrel. The study monitors platelet reactivity and any bleeding or heart-related events for up to six months.
Medications involved: Prasugrel, ticagrelor, and clopidogrel all prevent blood clots by stopping platelets from sticking together, but they work through slightly different mechanisms and may have different bleeding risks.
Study on Reducing Bleeding by Omitting Aspirin in Patients with Non-ST Elevation Acute Coronary Syndrome
This trial is being conducted in Belgium and the Netherlands and examines whether stopping aspirin can reduce bleeding without increasing heart-related problems.
Who can participate: Both men and women with non-ST-segment elevation acute coronary syndrome who have undergone successful stent placement are eligible. Participants should not be from vulnerable populations.
Who cannot participate: People with severe bleeding history, stroke in the past six months, severe liver disease, kidney failure requiring dialysis, those currently in another trial, pregnant or breastfeeding women, known allergies to study medications, or other conditions making participation unsafe are excluded.
What the study is testing: The study examines whether omitting aspirin can reduce bleeding risk while still protecting against heart attacks and strokes. Participants will receive either aspirin or a placebo and be monitored for up to 12 months.
Medications involved: Aspirin is commonly used to prevent blood clots and reduce pain and inflammation. In this trial, it is being studied in combination with other antiplatelet medications.
Study on the Effects of Ticagrelor and Rivaroxaban in Patients with Atrial Fibrillation After Coronary Stent Surgery
This trial is taking place in Germany, France, Netherlands, Italy, Spain, Belgium, Finland, and Poland. It focuses on patients with atrial fibrillation who have undergone stent placement.
Who can participate: Patients must be 18 or older with atrial fibrillation or flutter requiring blood thinners for at least 12 months. They must have had successful stent placement within the last 7 days with no major complications and provide written consent.
Who cannot participate: Those who have not had successful stent placement, are not indicated for blood thinners, do not have atrial fibrillation, are outside the age range, or belong to vulnerable populations are excluded.
What the study is testing: The trial compares using a single antiplatelet medication for one month followed by a blood thinner alone versus the current standard of multiple medications. The goal is to determine if the simpler approach is as safe and effective while potentially reducing bleeding risk. Participants will be followed for 15 months.
Medications involved: P2Y12 inhibitors stop platelets from sticking together, while direct-acting oral anticoagulants thin the blood to prevent clots. The study examines whether using these medications in sequence is better than using multiple medications together.
Study Comparing Single and Dual Antiplatelet Therapy with Clopidogrel and Acetylsalicylic Acid in Elderly Patients or Those at Risk of Bleeding After Balloon Surgery
This trial is being conducted in Italy, Luxembourg, Spain, and Belgium. It examines treatment approaches for elderly patients or those at high bleeding risk who have undergone drug-coated balloon surgery.
Who can participate: Patients must be at least 75 years old or have high bleeding risk. They must have had successful drug-coated balloon treatment on 1 to 3 heart arteries measuring between 2.0 and 4.0 mm in diameter, with either stable or unstable coronary syndromes. They must provide informed consent.
Who cannot participate: Those without the required heart conditions, unsuccessful procedures, inability to complete the 12-month follow-up, inability or unwillingness to take the required medications, or any condition making participation unsafe are excluded.
What the study is testing: The trial compares using one antiplatelet medication versus two to determine if single therapy is as effective while potentially reducing bleeding risk. Patients will be followed for 12 months to track outcomes like death, need for additional procedures, and heart attacks.
Medications involved: Single antiplatelet therapy uses one medication to reduce clotting, while dual therapy uses two medications for stronger protection. The drug-coated balloon releases medication during the procedure to help prevent the blood vessel from narrowing again.
Study on Controlling Coronary Risk Factors and Platelet Aggregation Using Ramipril, Acetylsalicylic Acid, and Atorvastatin Calcium Trihydrate in Patients with Heart Disease
This Spanish trial examines the effectiveness of a combination pill containing three medications for managing heart disease risk factors.
Who can participate: Patients must be over 18 years old with ischemic heart disease currently receiving treatment with the Trinomia polypill for secondary prevention. They must be able to attend six study visits and sign informed consent.
Who cannot participate: Those with uncontrolled risk factors for heart disease, problems with platelet aggregation, outside the specified age range, or part of vulnerable populations are excluded.
What the study is testing: The trial compares blood pressure and cholesterol control when taking a combination pill versus taking the three medications separately. Each treatment period lasts three months, for a total of six months. This helps determine if the combination pill is as effective as separate medications.
Medications involved: Trinomia combines ramipril for blood pressure, aspirin to prevent clots, and atorvastatin to lower cholesterol. Taking these as one pill may help patients take their medications more regularly.
Study on Metformin’s Effect in Reducing Unplanned Heart Procedures in Non-Diabetic Patients with Acute Coronary Syndrome
This Polish trial is studying metformin, a medication commonly used for diabetes, in patients without diabetes who have had acute coronary syndrome.
Who can participate: Patients must be over 18 years old experiencing their first episode of acute coronary syndrome treated with a drug-eluting stent. They must live close enough for easy monitoring, have an uncomplicated course, no history of diabetes, have not taken blood sugar-lowering medications in the last 6 months, have an HbA1c level below 6.5%, and provide written consent.
Who cannot participate: People with diabetes, those who have not undergone stent placement, those not experiencing acute coronary syndrome, people under 18, or those from vulnerable populations are excluded.
What the study is testing: The trial evaluates whether metformin can reduce the need for additional unplanned procedures to restore blood flow to the heart. Participants will take metformin as a coated tablet and be monitored for heart-related events over up to 30 months.
Medications involved: Metformin typically manages blood sugar in people with diabetes, but this study examines whether it might also have benefits for heart health in people without diabetes who have had acute coronary syndrome.
Study on Short vs. 12-Month Use of Prasugrel and Aspirin for Patients with Acute Coronary Syndromes Undergoing Stent Procedures
This Danish trial compares short-term versus 12-month treatment with antiplatelet medications in patients who have had stent placement.
Who can participate: Patients must be 18 or older with acute coronary syndromes who have been treated with an everolimus-eluting stent and can be treated with prasugrel for 12 months. Both men and women can participate, but not vulnerable populations.
Who cannot participate: Those without acute coronary syndromes, outside the specified age range, or from vulnerable populations are excluded.
What the study is testing: The trial compares short-term antiplatelet therapy to 12-month treatment to determine which approach better balances preventing blood clots and reducing bleeding. The study will monitor bleeding events and major heart or brain-related problems between 1 and 12 months after the procedure. The trial is expected to run until the end of 2028.
Medications involved: Prasugrel and aspirin both prevent blood clots by stopping platelets from sticking together. Everolimus-eluting stents slowly release medication to help prevent the artery from becoming blocked again.
Summary
These 14 clinical trials represent a comprehensive effort to improve treatment approaches for acute coronary syndrome across Europe. Several key themes emerge from these studies. Multiple trials focus on finding the right balance between preventing blood clots and reducing bleeding risk, which is a major concern with antiplatelet and anticoagulant medications. Several studies are examining whether simplified treatment approaches, such as using single medications instead of combinations or shorter treatment durations, can provide similar benefits with fewer side effects.
There is notable geographic concentration, with many trials taking place across multiple European countries, particularly in Western Europe. Poland appears frequently as a trial location, hosting four individual studies. The trials show significant diversity in the approaches being tested, from new medications like milvexian to repurposing existing drugs like metformin for new uses. Several studies focus on specific patient populations, such as elderly patients, those at high bleeding risk, or those with additional conditions like atrial fibrillation.
The medications most frequently studied include antiplatelet drugs like ticagrelor, clopidogrel, and prasugrel, as well as anticoagulants like dabigatran and rivaroxaban. These trials collectively aim to refine treatment strategies to improve outcomes while minimizing complications for patients with acute coronary syndrome.
