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
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
Krakowskie Centrum Medyczne Sp. z o.o. Cracow Poland
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
Futuremeds Warszawa Centrum Warsaw Poland

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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
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie Lublin Poland
Clinique Saint Hilaire Rouen France
Cardioconsult s.r.o. Stare Mesto Slovakia
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Azorg Aalst Belgium
Mcbk s.c. Iwona Czajkowska Anna Podrazka Szczepaniak Pruszkow Poland
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Kfiewrd Mdfyydc Cyoswz Lclb Sofia Bulgaria
Mifczty Catpjj Mgrxfi Pobo Lhhn Veliko Tirnovo Bulgaria
Nvkrgizu Muhckqtxtujhsbqwm Ttcadbpiy Hezdoidq Tsha Blvec Iri Sofia Bulgaria
Iylgms Zswidwjbpj Rotterdam The Netherlands
Ovhebkktx vbm Tsidww Dendermonde Belgium
Azvbuyqqz Mtczzem Cktywy Ozx Dupnitsa Bulgaria
Mcvkqwvqhxsau Hwvzcylg fic Aekwsp Tyjqefonz Hmwys ajm Bytkk Eox Pleven Bulgaria
Cjbdss Dejpxrj scrzec Kzujus Kosice Slovakia
Mjkz Maqcwrx sboksb Moldava Nad Bodvou Slovakia
Mujbytq Cyhfwj Iecxct Eoab Sofia Bulgaria
Omqanktq pbm ciyhyed sgrub sevipi Chomutov Czechia
Hedpoohp Lg Lnc Ghsxj Qjwlmpkeqnv Madrid Spain
Mwrtnehc skwomw Zilina Slovakia
Mdvypgwfkmwyu Vfxudmoywnreonhkeu Jmdw Gqr Deggingen Germany
Eezwtjosszsdychnidds Zeavymdirl Tilburg The Netherlands
Zunylrebwj Bjoctug Cjuhaqo Cakovec Croatia
Fjrmayqtplhcuhf Dawjmrjucdllxect Bisoqkluccytblvwjmyh mvl Dresden Germany
Mpafjimcftxh Hifebleq Fvu Amijeg Tvwynniuy Slyoo Eyymahzpnntjhabvmbdfkp Eduo Dimitrovgrad Bulgaria
Gutkkva Hdxxgoro Ob Nsn Iiivt Khbwxlompwmtxttz Ptfyancj Nea Ionia Greece
Cnqldcknwfkwsmivq pwxtcpm sycxsw Moravska Ostrava A Privoz Czechia
Bghmdff Bcf Debrecen Hungary
Miiyn Npip Zngococ svvwoe Uherske Hradiste Czechia
Ldzwnlo sjilni Kromeriz Czechia
Kpbnmprfkgg Ktkaj sdearg Pulecny Czechia
Iwqympgcil Db Uyphzpl Pflneq Bgfk Cfrhjsmzulncydv Pombt Dxq Cl Cb Icrznqk Bucharest Romania
Mpastoe chjqvk 4ftwm Ljzz Burgas Bulgaria
Ouxz Buxnrio Dyyeybsht Dubrovnik Croatia
Ozqn Bdthjfv Vwkwnaqq Varazdin Croatia
Cvvghlbhvncd spaacu Nove Zamky Slovakia
Afznzlvug Sjzgyl Cluj Napoca Romania
Vezfp sidert Petrzalka Slovakia
Kbidmdxhduhfqsbg cwqyxhj smragg Nove Mesto Slovakia
Gafkrsbzmvctfo Gncfjzvsujfr dpa Fabgoetqugrawktsr zd Orev mxs Bonn Germany
Decdtgzwya Mypqxbi Cpufld 2onn Lulv Dimitrovgrad Bulgaria
Moakyfjqfs Kgeafcyp Myuox Grho Mainz Germany
Zxlyzzk fpq klpnfuklu Stdshli Bdi Hulavix Bad Homburg Germany
Kynnorvmhhr ib Szgpvhtbsl Berlin Germany
Gqwpoynygkszkqjlgue Mioyxgkeegqjw &xnzwbz Duv Lr Pvmpsxwwkl Tq Dwzshadw Stuhr Germany
Sozdjsgnkij Hcjhpqolr &xolehy Kxmzbfgr af Plitarfaecx Brj Fmsenwrkcjryxx Bad Friedrichshall Germany
Pmfofc Dn Mad Czuepite Bnmcyl Hamburg Germany
Idtkqzjiqlyq Sfpobuyywgjhjsy Pkndwawx Lhwwcvzs w dcngnufyid kbxbzlulwbb Lnn mjnj Knctgohoh Cnjeszau Gdynia Poland
Woykrfpnmt Scfoubo Iiv Svrklzr Pqt W Pzguosezm Przemysl Poland
Cbobfesx Hrndfrwu Dmrtffs Zagreb Croatia
Kwfpnzjauzccv avrwvfasv sprqdq Příbram Czechia
Ckptuacu sytajm Prague Czechia
Uat Mnrnrit Tnumof Kfnn Budapest Hungary
Mclhaydy Kbdh Budapest Hungary
Kwuobkgiysb a actkisewqo smqiec Prague Czechia
Ftabrdpy Niewjvowo S Pztfwvplkjxg Jc Aj Rbyhmpb Pqmjkc Presov Slovakia
Mkskqgvj Swu z oghi Oświęcim Poland
Cxugkcu Myxvgldb Phwjpk Kziecoyu Katowice Poland
Dnszgclddjfgirvcpmqpfcn Cpfiol Adlakjqbatkvy Eabg Sofia Bulgaria
Ihabeja Ovtvoblr shwlbh Brandys Nad Labem Czechia
Mmlas Jdp Hvotf sfhfgi Chrudim Czechia
Szwuvrpvxsjnxi Bjftctzwozhoxccf Essen Germany
Cophgxolz db Sjpcvjrqpknsiv Arlon Belgium
Bsuligofyvxhsh ez Kwzeetkxacpj Mdhgdfhdxvgk Bekescsaba Hungary
Kckjttfiivzvqo Pmxrvt Ppjvtgqlm Papenburg Germany
Ralrmj Mxpbvhweyfz 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.

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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