Comparison of milvexian and apixaban in reducing stroke risk in patients with atrial fibrillation

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    What is this study about?

    This study is designed to compare two drugs, Milvexian and Apixaban to reduce the potential risk of stroke for patients suffering from atrial fibrillation, a common heart rhythm disorder. 15500 participants, aged 18 years and older will be invited to partake in this research. Participants will be randomly designated to receive either Milvexian or Apixaban. The study team aims to determine if Milvexian is at least as effective as Apixaban in reducing the risk of combined stroke and Non-central nervous system (CNS) systemic embolism. Furthermore, the research team will evaluate the occurrence rates of various health incidents including major bleeding, various cardiovascular complications, death, and other severe conditions over a 4-year period. The goal is to find out which medication proves safer and more effective in preventing severe health risks linked with this disorder. Study commencement is April 11, 2023, with completion targeted at May 5, 2027.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Aalst , Belgium

      Arlon , Belgium

      Edegem , Belgium

      La Louviu00e8re , Belgium

      Mol , Belgium

      Roeselare , Belgium

      Blagoevgrad , Bulgaria

      Dimitrovgrad , Bulgaria

      Dimitrovgrad , Bulgaria

      Dupnitsa , Bulgaria

      Haskovo , Bulgaria

      Kardzhali , Bulgaria

      Pleven , Bulgaria

      Pleven , Bulgaria

      Pleven , Bulgaria

      Ruse , Bulgaria

      Ruse , Bulgaria

      Sevlievo , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Varna , Bulgaria

      Veliko Tarnovo , Bulgaria

      Veliko Tarnovo , Bulgaria

      Bilovec , Czechia

      Brandu00fds nad Labem , Czechia

      Brno , Czechia

      Brno , Czechia

      Broumov , Czechia

      Chomutov , Czechia

      Jablonec nad Nisou , Czechia

      Kromeriz , Czechia

      Litovel , Czechia

      Olomouc , Czechia

      Ostrava Poruba , Czechia

      Prague , Czechia

      Praha 10 , Czechia

      Praha 1 , Czechia

      Pribram , Czechia

      Trutnov , Czechia

      Uherske Hradiste , Czechia

      Zlin , Czechia

      Aarhus , Denmark

      Copenhagen S , Denmark

      Herlev , Denmark

      Herning , Denmark

      Hvidovre , Denmark

      Svendborg , Denmark

      Angers Cedex 9 , France

      Paris Cedex 12 , France

      Paris , France

      Paris , France

      Altenburg , Germany

      Bad Friedrichshall , Germany

      Bamberg , Germany

      Berlin , Germany

      Berlin , Germany

      Bielefeld , Germany

      Bonn-Beuel , Germany

      Dachau , Germany

      Deggingen , Germany

      Dessau-Rosslau , Germany

      Dresden , Germany

      Dresden , Germany

      Dresden , Germany

      Elsterwerda , Germany

      Essen , Germany

      Essen , Germany

      Essen , Germany

      Frankfurt , Germany

      Hamburg , Germany

      Hamburg , Germany

      Hamburg , Germany

      Kiel , Germany

      Mainz , Germany

      Mannheim , Germany

      Nuremberg , Germany

      Papenburg , Germany

      Stuhr , Germany

      Wermsdorf , Germany

      Worms , Germany

      Baja , Hungary

      Balatonfured , Hungary

      Bekescsaba , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Debrecen , Hungary

      Hatvan , Hungary

      Miskolc , Hungary

      Mosonmagyarovar , Hungary

      Nyiregyhaza , Hungary

      Oroshaza , Hungary

      Pecs , Hungary

      Szekesfehervar , Hungary

      Zalaegerszeg , Hungary

      Arezzo , Italy

      Bergamo , Italy

      Caserta , Italy

      Ferrara , Italy

      Lecco , Italy

      Massa , Italy

      Milano , Italy

      Monza , Italy

      Pavia , Italy

      Pisa , Italy

      Roma , Italy

      Roma , Italy

      Rozzano , Italy

      Sassari , Italy

      Almelo , Netherlands

      Amersfoort , Netherlands

      Amsterdam , Netherlands

      Delft , Netherlands

      Deventer , Netherlands

      Doetinchem , Netherlands

      Ede , Netherlands

      Gouda , Netherlands

      Heerlen , Netherlands

      Helmond , Netherlands

      Leiderdorp , Netherlands

      Nijmegen , Netherlands

      Rotterdam , Netherlands

      s-Hertogenbosch , Netherlands

      Sneek , Netherlands

      Tilburg , Netherlands

      Veldhoven , Netherlands

      Zutphen , Netherlands

      Bydgoszcz , Poland

      Bydgoszcz , Poland

      Chorzow , Poland

      Chrzanow , Poland

      Gdansk , Poland

      Gdynia , Poland

      Grodzisk Mazowiecki , Poland

      Katowice , Poland

      Katowice , Poland

      Krakow , Poland

      Krakow , Poland

      Krakow , Poland

      Legnica , Poland

      Lodz , Poland

      Lodz , Poland

      Lodz , Poland

      Lodz , Poland

      Lowicz , Poland

      Lublin , Poland

      Oswiecim , Poland

      Piaseczno , Poland

      Siedlce , Poland

      Skierniewice , Poland

      Warszawa , Poland

      Zamosc , Poland

      Zamosc , Poland

      Covilha , Portugal

      Figueira da Foz , Portugal

      Lisboa , Portugal

      Santa Maria da Feira , Portugal

      Torres Novas , Portugal

      Braila , Romania

      Brasov , Romania

      Brasov , Romania

      Bucharest , Romania

      Bucuresti , Romania

      Pitesti , Romania

      Suceava , Romania

      Targu Mures , Romania

      Bardejov , Slovakia

      Bratislava , Slovakia

      Kosice , Slovakia

      Lucenec , Slovakia

      Lucenec , Slovakia

      Moldava nad Bodvou , Slovakia

      Nove Zamky , Slovakia

      Presov , Slovakia

      Svidnik , Slovakia

      A Coruu00f1a , Spain

      Alicante , Spain

      Barcelona , Spain

      Madrid , Spain

      Santiago de Compostela , Spain

      Bristol , United Kingdom

      London , United Kingdom

      Truro , United Kingdom

      You can join this study in:

      Study Steps

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

      The steps a patient needs to take in this clinical trial are as follows:

      1. Take milvexian 100 milligrams (mg) orally, twice daily.
      2. Along with the drug, take a placebo that matches apixaban, beginning on Day 1 through the end of treatment (EOT).
      3. After the EOT visit, participants may have the option to receive open-label apixaban at the appropriate dose (either 5 mg or 2.5 mg, twice daily), and the sponsor will provide a 30-day supply.

      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on disease criteria, participants must have one or more of the following conditions:

      1. Atrial fibrillation eligible to receive anticoagulation, and
      2. Participant must satisfy one or both of the following categories of risk factors:
        1. One or more of the following risk factors:
          1. Age greater than or equal to 75 years,
          2. History of a clinically symptomatic stroke.
        2. Two or more of the following risk factors:
          1. Age between 65 and 74 years,
          2. Hypertension,
          3. Diabetes mellitus,
          4. Atherosclerotic vascular disease,
          5. Heart failure.

      These are the diseases listed in the inclusion criteria for the study.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      1. Minimum age of 18 years: You must be at least 18 years old to participate in the study.
      2. Medically stable and appropriate for chronic antithrombotic treatment: You should be in a stable medical condition and deemed suitable to receive long-term treatment with medications that prevent blood clots.
      3. Atrial fibrillation eligible to receive anticoagulation: You must have atrial fibrillation, which is an irregular and often rapid heart rate that can increase the risk of strokes, heart failure, and other heart-related complications. You must also be considered a candidate to receive anticoagulant drugs, which are used to prevent the formation of harmful blood clots.
      4. Participant must satisfy one or both of the following categories of risk factors:
        1. Category a: You must have one or more of the following risk factors:
          1. Age greater than or equal to 75 years: Being 75 years old or older is considered a risk factor for stroke.
          2. History of a clinical symptomatic stroke: You have experienced a stroke with symptoms in the past. A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients.
        2. Category b: You must have two or more of the following risk factors:
          1. Age between 65 and 74 years: Being in this age range is considered a risk factor for stroke.
          2. Hypertension: High blood pressure increases the risk of heart disease and stroke.
          3. Diabetes mellitus: A chronic condition that affects how your body turns food into energy. It increases the risk of various cardiovascular problems, including stroke.
          4. Atherosclerotic vascular disease: A condition where the arteries become narrowed and hardened due to a buildup of plaque around the artery wall. It can lead to serious problems, including heart attack or stroke.
          5. Heart failure: A condition in which the heart can’t pump enough blood to meet the body’s needs, which could increase the risk of blood clots forming.

      These criteria are designed to select participants who are at a higher risk of stroke and are able to safely undergo long-term anticoagulation therapy.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      • Hemodynamically significant valve disease: This refers to heart valve problems that affect the flow of blood through the heart. For this study, if your valve disease is serious enough to potentially need surgical replacement during the duration of the trial, you cannot participate.
      • Chronic anticoagulation for conditions other than AF (Atrial Fibrillation): If you have a condition that requires ongoing blood-thinning medication (anticoagulants) for reasons other than atrial fibrillation, which is an irregular and often rapid heart rate, you’re excluded from this study.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Milvexian: An orally administered experimental drug. It is a Factor XIa inhibitor, which is being investigated for reducing the risk of stroke and systemic embolism in patients with atrial fibrillation.
      2. Apixaban (active substance: Apixaban): An anticoagulant medication that is taken orally. It is a Factor Xa inhibitor, approved for the prevention of stroke and systemic embolism in people with nonvalvular atrial fibrillation.

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

      The clinical trial is evaluating two active substances:

      1. Milvexian: Milvexian is being studied as an experimental drug. It is an oral Factor XIa Inhibitor that is being compared to apixaban for its efficacy in reducing the risk of stroke and non-central nervous system (CNS) systemic embolism in participants with Atrial Fibrillation.
      2. Apixaban: Apixaban is a known anticoagulant medication used to treat and prevent blood clots. It works as a factor Xa inhibitor. It is used as the active control in this study to compare with Milvexian.

      Both of these substances are related to medicine and medical literature. Milvexian seems to be newer and under experimental investigation, while Apixaban is already an established treatment option in current medical practice.


      Study ID

      CT-EU-00019899

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Medicinal Product