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?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
M2m Med. Sp. z o.o. Chorzow Poland
Linden Sp. z o.o. sp.k. Cracow Poland
IRCCS Humanitas Research Hospital Rozzano Italy
Unidade Local De Saúde De Santa Maria, E.P.E. Lisbon Portugal
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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Unidade Local De Saude De Lisboa Ocidental E.P.E. Carnaxide Portugal
Kardiomed s.r.o. Lučenec Slovakia
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium
NZOZ Centurm Medyczne SERAFIN-MED Żarów Poland
Poliklinika Vlatka Cavka d.o.o. Zagreb Croatia
Kardiologische Praxis Dr. med. Ayham Al-Zoebi Wermsdorf Wermsdorf Germany
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
Futuremeds Łódź Lodz Poland
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu Wroclaw Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu Wroclaw Poland
Futuremeds Sp. z o.o. Wroclaw Poland
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Stichting OLVG Amsterdam The Netherlands
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Acibadem City Clinic Diagnostic And Consultation Center Tokuda EAD Sofia Bulgaria
Diab Serwis Popenda Sp. j. Chorzow Poland
U 2 Serv Com S.R.L. Suceava Romania
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
ze:ro Praxen MVZ fuer Nierenerkrankungen und Bluthochdruck GmbH Mannheim Mannheim Germany
MUDr. Zdenek Vomacka kardiologie a interna s.r.o. Nova Ulice Czechia
Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet Budapest Hungary
Pratia S.A. Centrum Medyczne Pratia Bydgoszcz Bydgoszcz Poland
Centrum Medyczne Ogrodowa Sp. z o.o Lowicz Poland
Futuremeds Targówek Warsaw Poland
Klinisches Forschungszentrum Dr. Hagemann Essen Germany
NZOZ Neuro- Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy Poznan Poland

Other Sites

Site Name City Country Status
Narodowy Instytut Geriatrii Reumatologii I Rehabilitacji Im Prof. Dr Hab. Med. Eleonory Reicher Warsaw Poland
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Centre Hospitalier Universitaire Rouen Rouen France
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
Hospital General Universitario De Valencia Valencia Spain
Hospices Civils De Lyon Lyon France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Del Mar Barcelona Spain
Interna SK s.r.o. Svidnik Slovakia
Coromed-Smo Kft. Pecs Hungary
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej Biala Podlaska Poland
Klinikum Coburg GmbH Coburg Germany
Clinexpert Kft. Budapest Hungary
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD Sofia Bulgaria
Medicus Services s.r.o. Brandys Nad Labem Czechia
Opca Bolnica Zadar Zadar Croatia
Medical Center Rodopimed EOOD Kirdzhali Bulgaria
Evangelisches Krankenhaus Witten gGmbH Witten Germany
Poradnia Kardiologiczna Jaroslaw Jurowiecki Gdansk Poland
Sal Med S.R.L. Pitesti Romania
Klaipeda University Hospital Klaipeda Lithuania
Semmelweis University Budapest Hungary
Assistance Publique Hopitaux De Paris Paris France
Klinikum Worms gGmbH Worms Germany
Slagelse Hospital Slagelse Denmark
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD Sofia Bulgaria
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
In Vivo Sp. z o.o. Bydgoszcz Poland
Reinier de Graaf Groep Delft The Netherlands
Vojenska Nemocnice Brno Brno-Zidenice Czechia
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Silmedic Sp. z o.o. Katowice Poland
Medical Center Teodora EOOD Ruse Bulgaria
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Medical Center Zara-Med EOOD Stara Zagora Bulgaria
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice Krapinske Toplice Croatia
Onassis Cardiac Surgery Center Kallithea Greece
BKS Research Kft. Hatvan Hungary
Sedimed Sp. z o.o. Wroclaw Poland
Kardio Brynow Sp. z o.o. Katowice Poland
ROcardia s.r.o. Prostejov Czechia
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Mqdujtm Catcmp Mogvfe Pekg Lqkb Veliko Tirnovo Bulgaria
Ndopgwzo Mnhkkqaeoehdvnvhy Tsdjlzimt Hofyhgce Tsvi Bwfyn Iez Sofia Bulgaria
Igyjnu Zcxlgtaxlc Rotterdam The Netherlands
Owqlqzhhq vmo Tqidxl Dendermonde Belgium
Aeiaewtze Mfwowfh Cpivdl Onv Dupnitsa Bulgaria
Mwjrimdwitsye Hppptqfh fyx Aubuce Tabcqlhfn Hydgj adi Bsbpq Eko Pleven Bulgaria
Cckwrx Dubofmk sihrpa Kpblud Kosice Slovakia
Mveo Mhwefgo seefyp Moldava Nad Bodvou Slovakia
Mllyblp Cndxsi Ivkzbr Elnm Sofia Bulgaria
Oqkbfyom pxl cwiquwo szcxv stsfwc Chomutov Czechia
Hygwtymj Ld Lyg Gspsk Qcokmlnudla Madrid Spain
Mdalnfew sbupya Zilina Slovakia
Mlbtnfjxfwjjq Vtqtrqszcofdtsoowc Jmah Gii Deggingen Germany
Exsdetbgxsehyzmhgcnb Zbjevmwyle Tilburg The Netherlands
Zpxuiblenq Bbmoqyy Cfnvxbd Cakovec Croatia
Fgfetadckwyrjxs Duihhjdjznikymez Bzkkibfcveqzvnhauyro mho Dresden Germany
Mlcgndpxwjnd Hpldvwlw Ftw Abzcfw Tkiuhfstn Scoyv Ehirttcakbvrqollsbestg Erxh Dimitrovgrad Bulgaria
Gnusyrc Hhblyleu Ox Nit Ilage Kgwwcleumvhuwmjn Psrqrjjj Nea Ionia Greece
Cvffkwacsckyexkch pxpsymj smjgxl Moravska Ostrava A Privoz Czechia
Bjzxiqj Bov Debrecen Hungary
Mdsew Nnnb Znamjus sffodo Uherske Hradiste Czechia
Lwhcmbc szhsws Kromeriz Czechia
Kbnrzkvklfa Kokgc sawvna Pulecny Czechia
Ibwkbufaih Dh Uixfqjk Pfojqa Buci Cfmitstgtcemcce Pdnrx Dil Cd Cm Ilvgaos Bucharest Romania
Mobccfe cpgaoz 4mklw Linx Burgas Bulgaria
Osyh Bvcknai Dcbrgruta Dubrovnik Croatia
Okcg Bmfmquv Vfxnozdc Varazdin Croatia
Cywvefvvatwt suhgip Nove Zamky Slovakia
Ahbexyoat Surqyv Cluj Napoca Romania
Vghma sajfti Petrzalka Slovakia
Knzdccxhdtihywwy cgchawb scnwph Nove Mesto Slovakia
Gjulcjyxvizrei Gtybhjhdqkoe dbq Fstoqzrvcdmqhzvoy zu Ojmt mks Bonn Germany
Dbiseydmzl Mevekit Cftrpa 2ncs Lrzz Dimitrovgrad Bulgaria
Magogyynuu Kfdkeoga Mgwca Gsvl Mainz Germany
Zoaccpa fbh kmspcoshu Ssejfss Bad Hwwsofp Bad Homburg Germany
Kfeykregvku im Sikvhrypfe Berlin Germany
Gmmsegslmnthqkuweje Mxggdhyehnxht &riysdo Dmx Ly Pxcbjguaxu Tz Dkovhmez Stuhr Germany
Scgsysgxllm Hhsguqhtb &jleucp Krwzzquo ay Pyfgroiymok Bqo Fggosdvmkqugaz Bad Friedrichshall Germany
Pvkxlz Dn Mbb Cotyixxn Bifvuq Hamburg Germany
Imrcdpswgphc Sgesfitgqkzydxp Ppppnwef Lscurjny w dfjcujwvad kdbxkigaesb Lqh mocm Kumesvmhi Cztydasi Gdynia Poland
Wufytuuwyd Sfgdwde Ine Sixuumi Pyu W Pcwjfyror Przemysl Poland
Ponptu Jwvfpxm Gykd Jelenia Gora Poland
Ceyetawz Hclcztje Dzulcsp Zagreb Croatia
Ksaypuovjubjl agwyslgzi sxagkc Příbram Czechia
Cjyekjnp sisdpk Prague Czechia
Ulc Mpeoyxx Tcqodb Kpcq Budapest Hungary
Mhlrcxye Kqgf Budapest Hungary
Kihntxiqnit a aeeztksyyq staqpr Prague Czechia
Fdgbgsvv Nblejconf S Psqardhlzoez Jf Az Rbvdvua Pshztd Presov Slovakia
Mzzyvehm Sxu z oilw Oświęcim Poland
Cvtafig Mztnqdfc Pxlwcu Kbezivkg Katowice Poland
Dbahdczxjtpealksuygbemv Cinyea Abngxhazqdpam Egzl Sofia Bulgaria
Inucxdq Opoywkmb snppox Brandys Nad Labem Czechia
Mpylx Jqw Htcfe sauqpb Chrudim Czechia
Stziwytdxarszl Buvjudtilfdhrbny Essen Germany
Cgrtgskhk dl Ssfglpgwqbbelt Arlon Belgium
Bgfplrrgrhqwlq et Khjjmslyefam Mefuktklnnyw Bekescsaba Hungary
Kfbffeykivmnmu Plpdke Pselcyjlr Papenburg Germany
Rlqbdi Mozihgeeipa Aarhus Denmark

Want to learn more about this study or check if you can participate? Contact us.

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.

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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