Study on risk reduction of heart complications with Milvexian

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    What is this study about?

    This study involves a drug called milvexian, which is being tested for people who have recently experienced a heart-related episode, like a heart attack or stroke (acute coronary syndrome). Half of the participants will receive milvexian, and the other half will get a placebo. The study’s main aim is to show that milvexian can help reduce the chance of major heart-related problems happening again. These problems include things like heart failure, another heart attack, or an ischemic stroke.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Braunau am Inn , Austria

      Linz , Austria

      Brasschaat , Belgium

      Brugge , Belgium

      Brussels , Belgium

      Bruxelles , Belgium

      Gent , Belgium

      Hasselt , Belgium

      Liege , Belgium

      Mechelen , Belgium

      Roeselare , Belgium

      Turnhout , Belgium

      Blagoevgrad , Bulgaria

      Burgas , Bulgaria

      Gabrovo , Bulgaria

      Haskovo , Bulgaria

      Pernik , Bulgaria

      Pleven , Bulgaria

      Pleven , Bulgaria

      Plovdiv , Bulgaria

      Plovdiv , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Brno , Czechia

      Brno , Czechia

      Ceske Budejovice , Czechia

      Hradec Kralove , Czechia

      Jihlava , Czechia

      Liberec , Czechia

      Pardubice , Czechia

      Plzen , Czechia

      Prague , Czechia

      Praha 2 , Czechia

      Praha 2 , Czechia

      Praha 4 , Czechia

      Slany , Czechia

      Aahus N , Denmark

      Copenhagen S , Denmark

      Hvidovre , Denmark

      Viborg , Denmark

      Corbeil Essonnes cedex , France

      Creteil , France

      La Tronche , France

      Le Coudray , France

      Lille Cedex , France

      Lyon , France

      Montauban , France

      Nu00eemes Cedex 9 , France

      Paris , France

      Paris , France

      Pessac , France

      Poitiers , France

      Rouen cedex , France

      Rouen , France

      Toulouse Cedex 9 , France

      Bad Friedrichshall , Germany

      Berlin , Germany

      Berlin , Germany

      Bielefeld , Germany

      Bitburg , Germany

      Bonn-Beuel , Germany

      Dresden , Germany

      Erfurt , Germany

      Hamburg , Germany

      Leverkusen , Germany

      Ludwigshafen , Germany

      Mainz , Germany

      Moenchengladbach , Germany

      Worms , Germany

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Alessandria , Italy

      Bergamo , Italy

      Bologna , Italy

      Chieti , Italy

      La Spezia , Italy

      Milano , Italy

      Milano , Italy

      Napoli , Italy

      Pavia , Italy

      Pisa , Italy

      Roma , Italy

      Sassari , Italy

      Treviglio , Italy

      Amersfoort , Netherlands

      Amsterdam , Netherlands

      Deventer , Netherlands

      Ede , Netherlands

      Enschede , Netherlands

      Goes , Netherlands

      Gouda , Netherlands

      Harderwijk , Netherlands

      Leiderdorp , Netherlands

      Maastricht , Netherlands

      Nijmegen , Netherlands

      Roosendaal , Netherlands

      s-Hertogenbosch , Netherlands

      Sneek , Netherlands

      Tiel , Netherlands

      Veldhoven , Netherlands

      Zutphen , Netherlands

      Bydgoszcz , Poland

      Bytom , Poland

      Elblu0105g , Poland

      Katowice , Poland

      Kielce , Poland

      Krakow , Poland

      Lublin , Poland

      Olsztyn , Poland

      Oswiecim , Poland

      Przemysl , Poland

      Siedlce , Poland

      Skierniewice , Poland

      Sopot , Poland

      Torun , Poland

      Warszawa , Poland

      Aveiro , Portugal

      Braga , Portugal

      Guimaru00e3es , Portugal

      Santa Maria da Feira , Portugal

      Brasov , Romania

      Bucuresti , Romania

      Constanta , Romania

      Craiova , Romania

      Iasi , Romania

      Tg. Mures , Romania

      Timisoara , Romania

      Banska Bystrica , Slovakia

      Bardejov , Slovakia

      Bratislava , Slovakia

      Brezno , Slovakia

      Kosice , Slovakia

      Kosice , Slovakia

      Kou0161ice , Slovakia

      Moldava nad Bodvou , Slovakia

      Nitra , Slovakia

      Svidnik , Slovakia

      Zvolen , Slovakia

      Alicante , Spain

      Barcelona , Spain

      Barcelona , Spain

      Lleida , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Santiago de Compostela , Spain

      Valencia , Spain

      Vigo , Spain

      Basingstoke , United Kingdom

      Birmingham , United Kingdom

      Birmingham , United Kingdom

      Bournemouth , United Kingdom

      Bristol , United Kingdom

      East Kilbride , United Kingdom

      Edinburgh , United Kingdom

      Leeds , United Kingdom

      Londonderry , United Kingdom

      London , United Kingdom

      London , United Kingdom

      Middlesbrough , United Kingdom

      Newcastle Upon Tyne , United Kingdom

      Plymouth , United Kingdom

      Portsmouth , United Kingdom

      Redhill , United Kingdom

      Taunton , United Kingdom

      Torquay , United Kingdom

      Yeovil , United Kingdom


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps you would need to take as a patient in this clinical trial are as follows:

      1. You must be enrolled within 7 days of having an acute coronary syndrome (ACS).
      2. You may have undergone cardiac catheterization with percutaneous intervention (PCI) or you might be managed conservatively with or without catheterization.
      3. You should be receiving antiplatelet therapy standard-of-care, either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT), as determined by the investigator.
      4. If you are assigned to the experimental group, you will receive milvexian 25 milligrams (mg), orally, twice daily.
      5. If you are assigned to the placebo comparator group, you will receive a placebo orally, twice daily.

      Please note that these are guidelines and the exact steps may vary depending on individual circumstances and the decisions of the investigators.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      In order to join the study, you need to meet specific disease-related eligibility criteria which include having had an index event that meets all the following criteria within 7 days prior to randomization:

      1. Clinical syndrome consistent with spontaneous cardiac ischemia.
      2. Diagnosis of acute coronary syndrome (ACS) which includes ST-elevation myocardial infarction (STEMI), non-STEMI, or unstable angina (UA).
      3. Cardiac biomarker elevation (such as troponin I, troponin T, creatine kinase-MB [CK-MB]) above the upper limit of normal as determined by the local laboratory.

      Additionally, participants must have at least two of the following risk factors:

      1. Age 65 or older.
      2. Diabetes mellitus.
      3. History of a prior myocardial infarction (MI), other than the index ACS event.
      4. Multivessel coronary artery disease (CAD).
      5. History of coronary artery bypass graft (CABG) surgery prior to the index ACS event.
      6. History of peripheral artery disease (PAD) or cerebrovascular disease (such as carotid atherosclerosis, intracranial artery stenosis).
      7. Conservative management, meaning no percutaneous intervention (PCI) or CABG after the index ACS event.
      8. At least one of the following high-risk angiographic features:
        1. Total stent length greater than 30 millimeters (mm).
        2. Thrombotic target lesion.
        3. Bifurcation lesion treated with more than one stent.
        4. Calcified target lesion treated with atherectomy.
        5. Treatment of obstructive left main or proximal left anterior descending artery for the index ACS event or clinical diagnosis of an anterior STEMI.

      Please note, these are specifically disease-related criteria, and exclusion criteria or other conditions for eligibility are not included in the list as per your request.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria

      1. Participants must have had an index event that meets all of the following criteria within 7 days prior to randomization:
        1. A clinical syndrome consistent with spontaneous cardiac ischemia: This means a condition where there is a sudden reduction in blood flow to the heart muscle, typically caused by obstruction or spasm of the coronary arteries, which are vessels that supply blood to the heart.
        2. Diagnosis of acute coronary syndrome (ACS): ACS includes several conditions such as ST-elevation myocardial infarction (STEMI), non-STEMI, or unstable angina (UA), which are all related to diminished blood flow in the coronary arteries.
        3. Cardiac biomarker elevation: An increase in substances such as troponin I, troponin T, or creatine kinase-MB (CK-MB) beyond the upper limit of what the local laboratory considers normal, indicating damage to the heart muscle.
      2. Participants must have at least 2 of the following risk factors:
        1. Age 65 or older.
        2. Diabetes mellitus: A chronic condition that affects the way the body processes blood sugar (glucose).
        3. History of a prior myocardial infarction (MI) other than the index ACS event: A myocardial infarction, commonly known as a heart attack, is the death of heart muscle from the sudden blockage of a coronary artery.
        4. Multivessel coronary artery disease (CAD): A condition where several arteries that supply blood to the heart muscle are narrowed or blocked.
        5. History of coronary artery bypass graft (CABG) surgery prior to the index ACS event: CABG is a surgery to restore normal blood flow to an obstructed coronary artery.
        6. History of peripheral artery disease (PAD) or cerebrovascular disease: PAD is a circulatory condition where narrowed arteries reduce blood flow to the limbs, while cerebrovascular disease affects the blood vessels and blood supply to the brain.
        7. Conservative management i.e., no percutaneous coronary intervention (PCI) or CABG after the index ACS event: A management approach where no surgical intervention is done to open narrowed coronary arteries.
        8. One or more high-risk angiographic features like a total stent length greater than 30 millimeters (mm), thrombotic target lesion, bifurcation lesion treated with more than one stent, calcified target lesion treated with atherectomy; or treatment of obstructive left main or proximal left anterior descending artery for the index ACS event: These criteria relate to the specifics of any previous procedures or the characteristics of the blockage in the heart’s arteries that indicate a higher risk status.
      3. All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening: They should not be pregnant as ascertained by a sensitive test that measures the levels of hCG, a hormone produced during pregnancy.
      4. A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention: Participants who are biologically capable of becoming pregnant should not be currently pregnant, breastfeeding, or planning to become pregnant for a certain period after the treatment in the study.

      These criteria ensure that participants have a comparable level of cardiovascular risk and that the results of the trial can be applied to a similar patient population whilst also ensuring the safety of potential participants who might be pregnant.

      What Reasons Could Exclude Me from the Study?

      Here is a list of conditions under which you cannot take part in the study, along with explanations for any medical terms:

      1. Myocardial Infarction (MI) secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI
        Explanation: If your heart attack (myocardial infarction) was caused by a situation where your heart’s demand for oxygen was greater than the supply, or it was due to a procedural complication related to a medical intervention rather than a blockage in the heart’s arteries.
      2. Planned Coronary Artery Bypass Graft (CABG) or Staged Percutaneous Coronary Intervention (PCI) after randomization
        Explanation: If you are scheduled to undergo a surgery to improve blood flow to the heart (CABG) or a procedure to open narrowed or blocked coronary arteries (PCI) after you are assigned to a study group.
      3. Condition that requires chronic anticoagulation
        Explanation: If you have a condition that needs ongoing treatment with anticoagulants (‘blood thinners’ to prevent clots) as determined by the study doctor and according to local guidelines.
      4. Conditions with a significant increased risk of bleeding
        Explanation: Situations where there is a high chance of bleeding, for example, if you have had clinically significant bleeding in the last 3 months, or have a known bleeding disorder where your blood does not clot properly.

      These exclusions help ensure participant safety and integrity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves the following drug:

      1. Milvexian (Also known as JNJ-70033093) – Milvexian is an experimental oral Factor XIa inhibitor. Factor XIa is an enzyme in the blood coagulation process that contributes to the formation of blood clots. Inhibiting this enzyme may reduce the risk of thrombosis, which is the formation of harmful clots that can lead to cardiovascular events such as myocardial infarction (heart attack) or stroke.

      A placebo is also used in the trial as a comparator, but it contains no active substance.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substance being studied in the clinical trial is Milvexian. Below is a list with a description of this substance:

      1. Milvexian: Milvexian is an oral Factor XIa inhibitor. It is being investigated for its potential to reduce the risk of major adverse cardiovascular events (MACE) in participants after a recent acute coronary syndrome. As per the clinical trial information, it is known by other names such as JNJ-70033093 and BMS-986177.

      Study ID

      CT-EU-00057780

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Medicinal Product