Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.

Summary

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.

Timeline

Start

2020-06-15

Primary completion

2022-02-18

Completion

2022-02-18

Publications

• Hart RG, Smith EE, Wang A, Mundl H, Colorado P, Joundi RA, Katsanos AH, Sharma M, Shoamanesh A. Location, size, and risk factors of incident covert brain infarcts in patients with acute non-cardioembolic ischemic stroke: PACIFIC-STROKE trial. Eur Stroke J. 2025 Dec;10(4):1413-1420. doi: 10.1177/23969873251344485. Epub 2025 Jun 13.
• Smith EE, Shoamanesh A, Xu L, Heenan L, Saad F, Colorado P, Chen CH, Lemmens R, De Marchis GM, Caso V, Masjuan J, Hirano T, Milanov I, Campbell BCV, Mas JL, Connolly SJ, Mundl H, Hart RG; PACIFIC-Stroke Steering Committee and Investigators. Effect of the Factor XIa Inhibitor Asundexian According to Baseline Infarct Pattern and on MRI Covert Infarct Outcomes. Stroke. 2024 Feb;55(2):392-402. doi: 10.1161/STROKEAHA.123.043198. Epub 2024 Jan 4.
• Whiteson HZ, Frishman WH. Factor XI/XIa Inhibitors: A New Approach to Anticoagulation. Cardiol Rev. 2025 Jul-Aug 01;33(4):306-311. doi: 10.1097/CRD.0000000000000624. Epub 2023 Dec 1.
• Balali P, Hart RG, Smith EE, Saad F, Colorado P, Lemmens R, De Marchis GM, Caso V, Xu L, Heenan L, Connolly SJ, Mundl H, Shoamanesh A. Cerebral microbleeds and asundexian in non-cardioembolic ischemic stroke: Secondary analyses of the PACIFIC-STROKE randomized trial. Int J Stroke. 2024 Jun;19(5):526-535. doi: 10.1177/17474930231216339. Epub 2023 Dec 16.
• Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.

Drugs

Indications