PACIFIC Stroke - 19766 - Non-cardioembolic ischaemic stroke

  • Research type

    Research Study

  • Full title

    Multicenter, randomized, placebo-controlled, double-blind, parallel group, dose-finding Phase 2 study to evaluate efficacy and safety of BAY 2433334 in patients following an acute noncardioembolic ischaemic stroke

  • IRAS ID

    275993

  • Contact name

    Thomson Robinson

  • Contact email

    tgr2@leicester.ac.uk

  • Sponsor organisation

    Bayer

  • Eudract number

    2019-003431-33

  • Clinicaltrials.gov Identifier

    NCT04304508

  • Duration of Study in the UK

    1 years, 1 months, 19 days

  • Research summary

    Summary of Research

    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 ischaemic stroke which occurs when a blood clot that has not formed in the heart traveled 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.

    Summary of Results

    Websynopsis (in technical language): see on Bayer Clinical Trials Explorer: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVPIP5oH8HR7Fy-2FpAc9Ye47jmj-2F-2FrxoOJPp-2BFrK-2F4EOxxTF-2FhlhHTgcEQe4CY6IYsg-3D-3D9Jb7_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL-2BxAI2vkfeUJugZE0IFgmyPdhzWgpLW2KV-2BBxB4CaK-2BdRoT1emiFuMmVuEp3LdzDqkCTiHqgZO14R1kmPJDtYoGyLU8zb3-2Fb-2FYOkGClxUYL4A5-2F2atAb-2B8T7IjKyPFUpYOXSpW1BKEAn0XtrWFiBil3biCx8rdIf-2Fxq5WJ80bZxw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C56458f7aac6f4f75f6ca08db3482b9d5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638161508288806465%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=KlDcTGLryEZsSrWheY%2FSkx%2Bexnaipwdt70agerkwfsg%3D&reserved=0

  • REC name

    East of England - Cambridge Central Research Ethics Committee

  • REC reference

    20/EE/0031

  • Date of REC Opinion

    2 Apr 2020

  • REC opinion

    Further Information Favourable Opinion