Testing Milvexian’s effectiveness in preventing repeat strokes

Recruting new patients

Select region:

Navigation:

    What is this study about?

    This research trial, called LIBREXIA-STROKE, will test a medication called Milvexian on those who have recently had a stroke or a high-risk ‘mini-stroke’. In its 3rd testing phase, the study will involve a system where the patients won’t know whether they are receiving the actual drug or a substitute with no effect, referred to as a ‘placebo’, to maintain fairness. Milvexian is a medication that can potentially reduce the risk of having another stroke, and this trial aims to observe how effective it is in doing so. The trial will look at when the first stroke happens after starting the trial, if other major heart or limb diseases occur, or if strokes occur in the first 90 days.

    Learn more about this Trial

      I accept the Terms of Use and Privacy Policy*

       I consent to the Service Operator sending commercial information*

      I consent to the Service Operator using telecommunications terminal devices and automatic calling systems in marketing communications*

      Success

      Your form submitted successfully!

      Error

      Sorry! your form was not submitted properly, Please check the errors above.

      Locations

      Where does the clinical trial take place?

      Wels , Austria

      Ath , Belgium

      Bonheiden , Belgium

      Bruxelles , Belgium

      Dendermonde , Belgium

      Edegem , Belgium

      Kortrijk , Belgium

      La Louviu00e8re , Belgium

      Liege , Belgium

      Blagoevgrad , Bulgaria

      Gorna Oryahovitsa , Bulgaria

      Haskovo , Bulgaria

      Pazardzhik , Bulgaria

      Pleven , Bulgaria

      Pleven , Bulgaria

      Plovdiv , Bulgaria

      Plovdiv , Bulgaria

      Ruse , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Sofia , Bulgaria

      Brno , Czechia

      Brno , Czechia

      Jihlava , Czechia

      Ostrava – Vitkovice , Czechia

      Poruba , Czechia

      Praha 2 , Czechia

      Praha 5 , Czechia

      Pu00edsek , Czechia

      Aarhus , Denmark

      Glostrup , Denmark

      Herning , Denmark

      u00c5lborg , Denmark

      HUS , Finland

      Turku , Finland

      Aix-en-Provence cedex 01 , France

      Besanu00e7on Cedex , France

      Bordeaux Cedex , France

      Bourg en Bresse cedex , France

      Brest cedex , France

      Chartres cedex , France

      Clermont Ferrand Cedex , France

      Garches , France

      La Roche sur Yon , France

      Laquenexy , France

      Lille Cedex , France

      Limoges , France

      Marseille cedex 05 , France

      Metz-Tessy , France

      Montpellier , France

      Nancy , France

      Paris , France

      Paris , France

      Paris , France

      Paris , France

      Poitiers , France

      Rouen Cedex , France

      Aachen , Germany

      Altenburg , Germany

      Berlin , Germany

      Berlin , Germany

      Dresden , Germany

      Essen , Germany

      Frankfurt , Germany

      Frankfurt , Germany

      Friedrichshafen , Germany

      Fulda , Germany

      Giessen , Germany

      Hamburg , Germany

      Hamburg , Germany

      Hamburg , Germany

      Leipzig , Germany

      Luebeck , Germany

      Lueneburg , Germany

      Minden , Germany

      Muenster , Germany

      Sande , Germany

      Schleswig , Germany

      Tuebingen , Germany

      Ulm , Germany

      Budapest , Hungary

      Debrecen , Hungary

      Brescia , Italy

      Cremona , Italy

      Foligno , Italy

      Genova , Italy

      L’Aquila , Italy

      Lecco , Italy

      Massa , Italy

      Milano , Italy

      Pavia , Italy

      Perugia , Italy

      Pietra Ligure , Italy

      Pisa , Italy

      Reggio Emilia , Italy

      Roma , Italy

      Roma , Italy

      Roma , Italy

      Trieste , Italy

      Udine , Italy

      Verona , Italy

      Breda , Netherlands

      Uden , Netherlands

      Bydgoszcz , Poland

      Chelmie , Poland

      Grodzisk Mazowiecki , Poland

      Gryfice , Poland

      Krakow , Poland

      Leszno , Poland

      Lodz , Poland

      Lublin , Poland

      Olsztyn , Poland

      Rybnik , Poland

      Skarzysko-Kamienna , Poland

      Staszow , Poland

      Torun , Poland

      Wejherowo , Poland

      Braga , Portugal

      Coimbra , Portugal

      Covilha , Portugal

      Lisboa , Portugal

      Lisboa , Portugal

      Santa Maria da Feira , Portugal

      Arad , Romania

      Brasov , Romania

      Bucuresti , Romania

      Constanta , Romania

      Targu Mures , Romania

      Timisoara , Romania

      Bratislava , Slovakia

      Levice , Slovakia

      Lucenec , Slovakia

      Martin , Slovakia

      Novu00e9 Zu00e1mky , Slovakia

      Spisska Nova Ves , Slovakia

      Trencin , Slovakia

      Zilina , Slovakia

      Alicante , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Cordoba , Spain

      Girona , Spain

      La Coruu00f1a , Spain

      Lleida , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Madrid , Spain

      Malaga , Spain

      Mostoles , Spain

      Palma de Mallorca , Spain

      Santiago de Compostela , Spain

      Sevilla , Spain

      Tarragona , Spain

      Terrassa , Spain

      Valencia , Spain

      Valladolid , Spain

      Vigo , Spain

      Gu00f6teborg , Sweden

      Malmoe , Sweden

      Sku00f6vde , Sweden

      Aberdeen , United Kingdom

      Airdrie , United Kingdom

      Cheltenham , United Kingdom

      Dundee , United Kingdom

      Exeter , United Kingdom

      Glasgow , United Kingdom

      Leicester , United Kingdom

      London , United Kingdom

      Luton , United Kingdom

      Nottingham , United Kingdom

      Wakefield , United Kingdom

      York , United Kingdom


      Study Steps

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

      The patient steps to participate in this clinical trial include:

      1. Eligibility assessment for inclusion criteria. This includes having had an ischemic stroke with specific characteristics or a high-risk transient ischemic attack (TIA).
      2. Being randomized into the trial as soon as possible and within 48 hours of the onset of the event.
      3. Undergoing or planning to undergo antiplatelet treatment according to international and/or local guidelines.
      4. For female patients, there must be no likelihood of being pregnant, breastfeeding, or planning to become pregnant until at least 4 days after the last dose of the study intervention.
      5. Agree to adhere to any lifestyle restrictions specified in the protocol.

      For the timeline, participants will take the study drug or placebo twice daily. However, this information does not specify the entire duration of the treatment. Would you like me to find more details about the duration of the treatment within the trial?


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To be eligible to join the study based on diseases, you would need to have had either:

      1. An ischemic stroke, which is a neurological deficit attributable to an acute brain infarction, and you must have a National Institutes of Health Stroke Scale (NIHSS) score of less than or equal to 7. Additionally, you must exhibit at least one of the following: persistent signs or symptoms of the ischemic event at the time of randomization, an acute ischemic brain lesion identified by standard-of-care neuroimaging, or you must have undergone thrombolysis or thrombectomy.

      2. A transient ischemic attack (TIA), characterized by an acute onset neurological deficit attributable to focal ischemia of the brain, with complete symptom resolution of the deficit and no brain infarction visible on neuroimaging (CT scan or MRI) and you must have an ABCD2 Score greater than or equal to 6.


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Here are the conditions you must meet to join the study, along with explanations of medical terms where necessary:

      1. Ischemic Stroke: You should have a neurological deficit caused by an acute brain infarction, which is a type of stroke where blood supply to part of the brain is interrupted. Your condition should score less than or equal to 7 on the National Institute of Health Stroke Scale (NIHSS), which is used to measure the severity of the stroke. Additionally, you must have persistent signs or symptoms of the ischemic event at the time of randomization or an acute, ischemic brain lesion shown in neuroimaging, or you must have undergone thrombolysis (dissolving blood clots) or thrombectomy (mechanical removal of blood clots).
      2. Transient Ischemic Attack: This is a temporary period of symptoms similar to those of a stroke. You must have an acute onset neurological deficit attributable to focal ischemia (restricted blood supply) of the brain with complete symptom resolution of the deficit and no brain infarction visible on neuroimaging, such as CT scan or MRI. Your ABCD2 Score must be greater than or equal to 6, which is a score used to predict the risk of stroke following a TIA.
      3. Randomization Timing: You will be randomized into the study as soon as possible, within 48 hours of the onset of an ischemic event.
      4. Antiplatelet Treatment: You must be currently using or planning to use antiplatelet treatment as per international or local guidelines. If acetyl salicylic acid (ASA), commonly known as aspirin, is used, it should be a low dose (75 to 100 milligrams per day).
      5. Female Participants: If you are a female participant, you must agree not to be pregnant, breastfeeding, or planning to become pregnant until 4 days after the last dose of the study intervention.
      6. Adherence: You must be willing and able to follow the lifestyle restrictions specified in the study protocol.

      These criteria are designed to ensure that participants are suitable for the study and to maintain the integrity and safety of the research.

      What Reasons Could Exclude Me from the Study?

      Exclusion Criteria:

      • Prior history of intracranial hemorrhage – If you’ve had bleeding inside the skull before, except for a type of bleeding called subarachnoid hemorrhage, which is okay if it occurred more than a year ago and was treated properly.
      • Cardio-embolic etiology of the stroke or TIA – If the stroke or transient ischemic attack (TIA) was caused by a heart problem that could send clots to the brain, and the standard guidelines recommend using blood thinners.
      • Stroke or TIA with a non-athero-thrombotic cause – If the stroke or TIA was due to a specific, identified cause that is not related to plaque buildup or clots in the arteries.
      • Increased risk of bleeding – If you’ve had severe bleeding in the last 3 months, have a condition that predisposes you to bleeding, or have test results showing prolonged bleeding time.
      • Current active liver disease – If you have an ongoing liver condition, like acute hepatitis or cirrhosis, including if you’re on medication for hepatitis.
      • Allergies to the study drug – If you are allergic or have had bad reactions to the study medication, milvexian, or any of its ingredients.

      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The clinical trial involves two drugs: Milvexian and a placebo. Details of the active substance Milvexian are provided as follows:

      1. Milvexian: This is an experimental drug being studied in this clinical trial. Milvexian is a novel oral anticoagulant that acts as a Factor XIa inhibitor. Factor XIa is a key enzyme in the coagulation cascade, which is essential for the formation of blood clots. By inhibiting Factor XIa, Milvexian aims to reduce the risk of recurrent ischemic stroke by preventing clot formation without significantly increasing the risk of bleeding which can be a side effect of anticoagulation therapy. In this study, participants who have experienced an acute ischemic stroke or high-risk transient ischemic attack and are receiving standard-of-care antiplatelet therapy will be randomly assigned to receive either Milvexian 25 milligrams (mg), orally, twice daily or a placebo .

      2. Placebo: A placebo is a substance with no active pharmacological effect. In clinical trials, a placebo is used as a control to determine the efficacy of an experimental drug. In this case, the placebo is used to assess the effectiveness of Milvexian. Participants in the placebo group will receive a placebo orally twice daily, alongside their standard-of-care antiplatelet therapy.

      The aim of the study is to evaluate whether Milvexian, compared to the placebo, can reduce the risk of recurrent ischemic stroke. This trial utilizes a double-blind, placebo-controlled design to provide unbiased results on Milvexian’s efficacy and safety for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack. Participants will not know whether they are receiving the experimental medication or placebo, and neither will the care providers, investigators, or outcomes assessors to ensure the integrity of the study results.

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

      The clinical trial involves the following active substance:

      Milvexian: This is an experimental drug being studied in the trial. It is an oral Factor XIa inhibitor, which is a new class of anticoagulants. Factor XIa is a clotting factor in the blood, and its inhibition is expected to reduce the risk of thrombosis without significantly increasing the risk of bleeding. Milvexian is given to participants who have experienced an acute ischemic stroke or high-risk transient ischemic attack and are receiving standard-of-care antiplatelet therapy. Milvexian is identified with other names such as JNJ-70033093 and BMS-986177, which indicates that it has been recognized in medical research but may not yet be widely known or available outside of clinical trials.

      Please note that the other active substance mentioned in the trial is a placebo, which has no therapeutic effects and is used as a comparator to assess the efficacy of milvexian.


      Study ID

      CT-EU-00057702

      Recruitment status

      Recruting new patients

      Start of the trial

      1 year ago

      Study phase

      Phase
      III

      Medicinal Product