Study Type
Interventional - Drug
completed
PACIFIC-Stroke was a 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.
Primary outcome measures:
- Number of participants with symptomatic ischemic stroke or covert brain infarcts detected by Magnetic resonance imaging (MRI). Baseline up to 6 months.
- Time from randomization to first occurrence of International Society on Thrombosis and Hemostasis (ISTH) major bleeding and clinically relevant non-major (CRNM) bleeding . Baseline up to 12 months.
Study Design
Randomized placebo controlled double-blind parallel group phase 2
NO. of Countries
25
NO. of Sites
250
NO. of Participants
1800
Study Period
2020 - 2022
Sponsor
Bayer
Ashkan Shoamanesh
Scientist
Ashkan Shoamanesh
Scientist
Ashkan Shoamanesh is the founding Director, Hemorrhagic Stroke Research Program and Scientist, at PHRI, Assistant Professor of Medicine (Neurology), McMaster University, and Director, Stroke Fellowship Program at Hamilton Health Sciences and McMaster. He is the inaugural Marta and Owen Boris Chair in Stroke Research and Care at McMaster. His research is focused on improving the clinical care of patients with stroke or who are at risk for stroke resulting from blood vessel rupture and bleeding into the brain.He is the founding Chair of the Canadian Hemorrhagic Stroke Trials Initiative (CoHESIVE) and leads as principal investigator the global phase III ENRICH-AF trial investigating optimal stroke prevention in intracranial hemorrhage survivors with atrial fibrillation in 22 countries.
He has been awarded the most prestigious early career awards in stroke granted by the American Heart/Stroke Association (2015 Mordecai Y.T. Globus and 2019 Robert G. Siekert New Investigator Awards in Stroke), American Academy of Neurology (2020 Michael S. Pessin Stroke Leadership Prize), and Heart and Stroke Foundation of Canada (2019 Henry J.M. Barnett Scholarship – recognizing the highest ranked National New Investigator in cerebrovascular disease research), amongst other notable awards, including the 2019 International Stroke Conference Paul Dudley White International Scholar Award and the 2014 European Stroke Conference Young Investigator Award.
Robert Hart
Senior Scientist
Robert Hart
Senior Scientist
Robert Hart is Professor of Medicine (Neurology) at McMaster University and a vascular neurologist at Hamilton Health Sciences. After completing a fellowship in cerebrovascular disease at the Oregon Health Sciences University, he spent most of his career at the University of Texas Health Science Center in San Antonio before relocating to McMaster University in September 2011.
He has a long-standing interest in stroke, stroke research, and clinical trials. He has directed several randomized clinical trials serving as the principal investigator of the NIH/NINDS-sponsored Stroke Prevention in Atrial Fibrillation (SPAF) I, II and III trials (1987-2000) and co-principal investigator of the NIH/NINDS-sponsored Secondary Prevention of Small Subcortical Strokes (SPS3) randomized trials (2001-2013). Antithrombotic therapies to prevent stroke in atrial fibrillation and especially novel oral anticoagulants are areas of special interest. He has published more than 250 articles in peer-reviewed journals.
Amanda Taylor
Associate Program Manager
Amanda Taylor
Associate Program Manager
Amanda Taylor is an Associate Program Manager who currently coordinates trials in stroke, and has experience conducting trials in acute coronary syndrome and arrhythmia. Amanda joined PHRI in 2007. She holds a Bachelor of Science Degree (Honours) in Neurobiology from Brock University.
Bayer
ESC 2022: Ashkan Shoamanesh on PACIFIC-Stroke trial
