HumRes62206
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SNCTP000005623
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BASEC2023-00620
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NCT05702034
A study on Milvexian in study participants after an acute ischemic stroke or a high-risk transient ischemic attack
Zusammenfassung der Studie
This study aims to assess whether Milvexian reduces the risk of recurrent ischemic stroke, which decreases blood flow, compared to placebo.
(BASEC)
Untersuchte Intervention
Study participants who experienced an acute ischemic stroke or a high-risk transient ischemic attack (TIA) receive Milvexian twice daily as part of standard treatment with antiplatelet therapy (with a single antiplatelet agent [SAPT] or with dual antiplatelet agents [DAPT]).
(BASEC)
Untersuchte Krankheit(en)
Ischemic stroke; transient ischemic attack
(BASEC)
Kriterien zur Teilnahme
- Ischemic stroke: a neurological deficit due to acute death of sections of brain tissue (acute cerebral infarction) and a score on the NIHSS stroke scale (National Institute of Health Stroke Score) less than or equal to (≤) 7, and at least one of the following conditions: persistent symptoms of the ischemic event at the time of random assignment, an acute ischemic injury to the brain confirmed by standard imaging of the central nervous system, resolution or surgical removal of a blood clot (thrombolysis or thrombectomy) or transient ischemic attack (TIA): acute onset of a neurological deficit attributable to focal ischemia of the brain, with complete resolution of the deficit symptoms and no cerebral infarction visible on imaging of the central nervous system (for example, computed tomography [CT] or magnetic resonance imaging [MRI]; performed as part of standard clinical practice), and an ABCD2 score greater than or equal to (≥) 6. - Random assignment occurs as soon as possible after confirming that the study is appropriate for the participant, and within 48 hours of the onset of the event. - Current or planned antiplatelet therapy according to international and/or local guidelines. If acetylsalicylic acid (ASA) is used, it is limited to a low dose (75 to 100 mg/day). The initial dose administered ("loading dose") of antiplatelet agents (including ASA) is permissible according to standard treatment. (BASEC)
Ausschlusskriterien
- Previous bleeding in the skull, except for bleeding in the space between the two meninges (subarachnoid hemorrhage), occurring more than (>) 1 year ago and appropriately treated. - For the first stroke or first TIA, it is assumed based on local standard examinations that the cause is an embolus from the heart, and guidelines recommend anticoagulation for this. - Increased risk of bleeding, including clinically significant bleeding within the last 3 months, or known tendency to bleed or known prolongation of the so-called "activated partial thromboplastin time" (aPTT) or spinal bleeding or retinal bleeding. (BASEC)
- Ischemic stroke: a neurological deficit due to acute death of sections of brain tissue (acute cerebral infarction) and a score on the NIHSS stroke scale (National Institute of Health Stroke Score) less than or equal to (≤) 7, and at least one of the following conditions: persistent symptoms of the ischemic event at the time of random assignment, an acute ischemic injury to the brain confirmed by standard imaging of the central nervous system, resolution or surgical removal of a blood clot (thrombolysis or thrombectomy) or transient ischemic attack (TIA): acute onset of a neurological deficit attributable to focal ischemia of the brain, with complete resolution of the deficit symptoms and no cerebral infarction visible on imaging of the central nervous system (for example, computed tomography [CT] or magnetic resonance imaging [MRI]; performed as part of standard clinical practice), and an ABCD2 score greater than or equal to (≥) 6. - Random assignment occurs as soon as possible after confirming that the study is appropriate for the participant, and within 48 hours of the onset of the event. - Current or planned antiplatelet therapy according to international and/or local guidelines. If acetylsalicylic acid (ASA) is used, it is limited to a low dose (75 to 100 mg/day). The initial dose administered ("loading dose") of antiplatelet agents (including ASA) is permissible according to standard treatment. (BASEC)
Ausschlusskriterien
- Previous bleeding in the skull, except for bleeding in the space between the two meninges (subarachnoid hemorrhage), occurring more than (>) 1 year ago and appropriately treated. - For the first stroke or first TIA, it is assumed based on local standard examinations that the cause is an embolus from the heart, and guidelines recommend anticoagulation for this. - Increased risk of bleeding, including clinically significant bleeding within the last 3 months, or known tendency to bleed or known prolongation of the so-called "activated partial thromboplastin time" (aPTT) or spinal bleeding or retinal bleeding. (BASEC)
Studienstandort
Aarau, Basel, Bern, Lausanne, St Gallen
(BASEC)
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam (ICTRP)
Sponsor
Janssen-Cilag International NV IQVIA AG, Branch Basel
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. Dr. Gerrit Maximilian Grosse
+41612652525
gerrit.grosse@clutterusb.chUniversitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland
(BASEC)
Allgemeine Auskünfte
Janssen Research & Development, LLC,
844-434-4210
gerrit.grosse@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
Janssen Research & Development, LLC
844-434-4210
gerrit.grosse@clutterusb.ch(ICTRP)
Allgemeine Auskünfte
Janssen Research & Development, LLC
844-434-4210
gerrit.grosse@clutterusb.ch(ICTRP)
Wissenschaftliche Auskünfte
Janssen Research & Development, LLC,
844-434-4210
gerrit.grosse@clutterusb.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
12.09.2023
(BASEC)
ICTRP Studien-ID
NCT05702034 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention after an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack (BASEC)
Wissenschaftlicher Titel
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, for Stroke Prevention After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack (ICTRP)
Öffentlicher Titel
A Study of Milvexian in Participants After an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack- LIBREXIA-STROKE (ICTRP)
Untersuchte Krankheit(en)
Ischemic Stroke Ischemic Attack, Transient (ICTRP)
Untersuchte Intervention
Drug: MilvexianDrug: Placebo (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
Inclusion Criteria:
- Ischemic Stroke: a neurological deficit attributable to an acute brain infarction
and national institute of health stroke score scale (NIHSS) score less than or equal
to (<=) 7 and at least 1 of the following: persistent signs or symptoms of the
ischemic event at the time of randomization, or acute, ischemic brain lesion
determined by standard-of-care neuroimaging, or participant underwent thrombolysis
or thrombectomy, or transient ischemic attack (TIA): acute onset neurological
deficit attributable to focal ischemia of the brain by history or examination, with
complete symptom resolution of the deficit and no brain infarction on neuroimaging
(example, computed tomography (CT) scan or magnetic resonance imaging (MRI),
performed as part of standard medical practice), and ABCD2 Score greater than or
equal to (>=) 6
- Participants will be randomized as soon as possible after determining eligibility
and within 48 hours of onset of event.
- Current or planned antiplatelet treatment per international and/or local guidelines.
If acetyl salicylic acid (ASA) is used, it will be limited to low dose (75 to 100
milligrams (mg)/day). Loading dose of antiplatelet agents (including ASA) are
allowed per standard-of-care
- A female participant must agree not to be pregnant, breastfeeding, or planning to
become pregnant until 4 days (5 half lives) after the last dose of study
intervention
- Willing and able to adhere to the lifestyle restrictions specified in this protocol
Exclusion Criteria:
- Prior history of intracranial hemorrhage except subarachnoid hemorrhage greater than
(>) 1 year prior with adequate treatment
- The index stroke or TIA is considered to have a cardio-embolic etiology based on
local standard-of-care investigations and for which guidelines recommend
anticoagulation
- The index stroke or TIA considered to have another known cause, not related to
athero-thrombotic sources (treatment of acute stroke trial [TOAST] Other Determined
Etiology), based on local standard-of-care investigations
- Increased risk of bleeding, including clinically significant bleeding within the
previous 3 months or known bleeding diathesis or known activated partial
thromboplastin time (aPTT) prolongation or spinal cord hemorrhage or retinal
hemorrhage
- Current active liver disease, eg, acute hepatitis, known cirrhosis, including
participants receiving antiviral treatment for hepatitis
- Known allergies, hypersensitivity, or intolerance to milvexian or its excipients (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Time to First Occurrence of Ischemic Stroke (ICTRP)
Time to First Occurrence of any Component of the Composite of Cardiovascular Death (CVD), Myocardial Infraction (MI), or Ischemic Stroke;Time to First Occurrence of Ischemic Stroke;Time to First Occurrence of any Component of Major Adverse Vascular Events (MAVE) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Bristol Myers Squibb Company (BMS) (ICTRP)
Weitere Kontakte
Janssen Research & Development, LLC Clinical Trial;Study Contact, Participate-In-This-Study@its.jnj.com, 844-434-4210, Janssen Research & Development, LLC, (ICTRP)
Sekundäre IDs
70033093STR3001, 2022-501176-26-00, CR109231 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05702034 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar