Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.
Inclusion Criteria:
Participant must be 45 years of age and older at the time of signing the informed consent
Non-cardioembolic ischemic stroke with
Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
Severity of index event nearest the time of randomization:
Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
Ability to conduct an MRI either before randomization or within 72 hours after randomization
Exclusion Criteria:
Ostend, 8400, Belgium
Ostrava Vitkovice, 70384, Czechia
Ostrava-Poruba, 708 52, Czechia
Praha 5-Motol, 150 00, Czechia
Forlì Cesena, Emilia-Romagna 47521, Italy
Kusegun, Kyoto 613-0034, Japan
Loures, Lisbon District 2674-514, Portugal
Santiago de Compostela, A Coruña 15706, Spain
Albacete, 02006, Spain
Barcelona, 08025, Spain
Madrid, 28034, Spain