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 non-cardioembolic ischemic stroke - PACIFIC-STROKE

Bayer AG0 个研究点目标入组 1,800 人开始时间: 2020年2月13日最近更新: 2022年4月4日

适应症

试验速览

暂无简介。

•1. Participant must be 45 years of age and older at the time of signing the informed consent
•2. Non-cardioembolic ischemic stroke with
•a. persistent signs and symptoms of stroke lasting for = 24 hours OR
•b. acute brain infarction documented by computed tomography (CT) or MRI AND
•c. with the intention to be treated with antiplatelet therapy during the study conduct
•3. Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
•4. Severity of index event nearest the time of randomization:
•a. Part A: minor stroke (defined as NIHSS = 7) can be enrolled
•b. Part B: participants with minor or moderate stroke and NIHSS = 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention
•5. 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)
•6. Ability to conduct an MRI either before randomization or within 72 hours after randomization
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 900

•1. Prior ischemic stroke within last 30 days of index event
•2. History of atrial fibrillation or suspicion of cardioembolic source of stroke
•3. Dysphagia with inability to safely swallow study medication at time of randomization
•4. Contraindication to perform brain MRI
•5. Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
•7. Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization

发起方