Study on Milvexian and Apixaban for Preventing Stroke in Patients with Atrial Fibrillation

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What is this study about?

This clinical trial is focused on studying Atrial Fibrillation, a common heart condition that causes an irregular and often rapid heart rate. The study is comparing two treatments: Milvexian, an oral medication that works by inhibiting a specific protein involved in blood clotting, and Apixaban, a well-known medication used to prevent blood clots. The purpose of the study is to determine if Milvexian is as effective as Apixaban in preventing strokes and other related complications in people with Atrial Fibrillation.

Participants in the study will be randomly assigned to one of two treatment groups: one group will receive Milvexian and a matching placebo that looks like Apixaban, while the other group will receive Apixaban and a matching placebo that looks like Milvexian. This means that all participants take both an active medication and a placebo, allowing the study to be conducted in a double-blind manner, so that neither the participants nor the researchers know which active treatment is being administered.

The study will last for up to 48 weeks. During this period, participants will take their assigned medication orally. Some participants may also receive a solution for infusion, known as Ondexxya, to help manage any potential side effects.

The main goal is to monitor the time it takes for participants to experience a stroke or a non-CNS systemic embolism, which is a type of blood clot that occurs outside the brain and spinal cord. Secondary goals include observing the occurrence of major bleeding and other cardiovascular events. The study aims to provide valuable information on the safety and effectiveness of Milvexian compared to Apixaban, potentially offering a new treatment option for individuals with Atrial Fibrillation.

Who Can Join the Study?

  • You must be at least 18 years old.
  • You must be in a steady medical state and suitable for long-term antithrombotic treatment, which is medicine used to prevent blood clots from forming.
  • You must have atrial fibrillation, which is an irregular and often rapid heart rhythm that can cause poor blood flow.
  • You must be able to receive anticoagulation therapy, which is a type of medication that helps prevent blood clots.
  • You must meet at least one of the following risk categories:
  • Category A: You are 75 years of age or older, or you have a history of stroke (when blood flow to part of the brain is cut off), silent brain infarcts (small areas of brain tissue death that show no symptoms), or cerebral microbleeds (tiny leaks of blood in the brain).
  • Category B: You have at least two of the following: being between 65 and 74 years old, hypertension (high blood pressure), diabetes mellitus (a condition affecting how your body uses blood sugar), atherosclerotic vascular disease (hardening of the arteries), or heart failure (a condition where the heart cannot pump blood as well as it should).

Who Cannot Join the Study?

  • You have atrial fibrillation (an irregular and often rapid heart rate that can cause poor blood flow) along with hemodynamically significant valve disease, which means a heart valve problem that is serious enough to affect how your heart pumps blood throughout your body.
  • You have a heart valve condition that might require surgical valve replacement (a surgery to take out a damaged heart valve and put in a new one) while the study is ongoing.
  • You have any medical condition, other than atrial fibrillation, that requires chronic anticoagulation (the long-term use of blood-thinning medication to prevent blood clots).

Where you can join this trial?

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M2m Med. Sp. z o.o. Chorzow Poland
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Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
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Kardiomed s.r.o. Lučenec Slovakia
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ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim Mannheim Germany
MUDr. Zdenek Vomacka kardiologie a interna s.r.o. Nova Ulice Czechia
IRCCS Humanitas Research Hospital Rozzano Italy
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
Kardiologische Praxis Dr. med. Ayham Al-Zoebi Wermsdorf Wermsdorf Germany
Futuremeds Łódź Lodz Poland
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu Wroclaw Poland
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o. Cracow Poland
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Katholieke Universiteit te Leuven Leuven Belgium
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Diab Serwis Popenda Sp. j. Chorzow Poland
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Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet Budapest Hungary
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Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Uoa Mahardy Tatqvk Kobo Budapest Hungary
Kbynuprffgz a apvhlhslsl swutoi Prague Czechia
Unzxjynbzp Gbzyetv Hhtpqidi Avojakf Athens Greece
Mppuonpo Sfi z orvs Oświęcim Poland
Chhwtjlsq di Snkfzsyxeyvgrs Arlon Belgium

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Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
15.08.2023
Bulgaria Bulgaria
Not recruiting
15.08.2023
Croatia Croatia
Not recruiting
15.08.2023
Czechia Czechia
Not recruiting
15.08.2023
Denmark Denmark
Not recruiting
15.08.2023
Estonia Estonia
Not recruiting
15.08.2023
France France
Not recruiting
15.08.2023
Germany Germany
Not recruiting
15.08.2023
Greece Greece
Not recruiting
15.08.2023
Hungary Hungary
Not recruiting
15.08.2023
Italy Italy
Not recruiting
15.08.2023
Latvia Latvia
Not recruiting
15.08.2023
Lithuania Lithuania
Not recruiting
15.08.2023
Poland Poland
Not recruiting
15.08.2023
Portugal Portugal
Not recruiting
15.08.2023
Romania Romania
Not recruiting
15.08.2023
Slovakia Slovakia
Not recruiting
15.08.2023
Spain Spain
Not recruiting
15.08.2023
The Netherlands The Netherlands
Not recruiting
15.08.2023

Trial locations

JNJ-70033093 is an experimental medicine being tested in this study to see if it can help prevent strokes and blood clots in people with an irregular heartbeat called atrial fibrillation.

Eliquis is a medication used as a comparison in this trial to evaluate how well the experimental treatment works. It is an oral medicine that helps prevent the formation of dangerous blood clots.

Ondexxya is a medication administered through an IV (intravenous) infusion that is used as a background therapy in this study.

Investigated diseases:

Atrial Fibrillation – This is a type of irregular heartbeat where the upper chambers of the heart beat out of sync with the lower chambers. It occurs when the electrical signals that control the heart rate become disorganized. As the condition progresses, the heart may beat too fast or with an irregular rhythm. This irregularity can lead to blood pooling in the heart chambers. Over time, this process increases the likelihood of blood clots forming.

Trial ID:
2022-501419-15-00
Protocol code:
70033093AFL3002
NCT ID:
NCT05757869
Trial Phase:
Therapeutic confirmatory (Phase III)

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