Study Type
Interventional - Drug
ongoing
With our aging demographics the burden of intracerebral hemorrhage (ICH) related morbidity and mortality, and the ensuing healthcare expenditures, are expected to increase substantially. Patients with ICH are at a high risk for thromboembolic events that is not being sufficiently mitigated by current treatment strategies. This is aggravated by cessation of antithrombotics due to fears of re-bleeding for significant periods after hemorrhage. These realities highlight the need for novel treatments that modify the natural history of ICH and mitigate cardiovascular risk in ICH survivors, without increasing the risk of recurrent ICH.
Randomized clinical trials suggest that colchicine has beneficial effects on major cardiovascular events prevention, without increasing the risk of bleeding. Moreover, its anti-inflammatory properties make it an attractive treatment candidate to mitigate secondary inflammatory brain injury in early ICH.
In CoVasc-ICH, adult patients with spontaneous acute intracerebral hemorrhage (ICH) enriched for systemic atherosclerosis will be randomly assigned to receive oral colchicine (0.5 mg once daily) or matching placebo (once daily). Randomization will occur within 48 hours of ICH symptom onset (or last seen normal).
The objectives of the CoVasc-ICH study are to:
- Demonstrate feasibility of recruitment
- Demonstrate reasonable medication adherence
- Demonstrate high retention rates
- Acquire preliminary safety/efficacy data about colchicine 0.5 mg once daily therapy in this specific patient population
Study Design
Double-blind vanguard randomized placebo-controlled Phase II pilot
NO. of Countries
1
NO. of Sites
10
NO. of Participants
100
Study Period
2022 - 2024
Sponsor
PHRI
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.
Aristeidis Katsanos
Investigator
Aristeidis Katsanos
Investigator
Aristeidis Katsanos is a neurologist at Hamilton Health Sciences, and a stroke/vascular neurology fellow at McMaster University/HHS. His academic focus is on the evidence-based evaluation of novel therapeutic approaches on acute stroke treatment and secondary stroke prevention. His research study on optimal blood pressure management after endovascular stroke treatment (DETECT) is supported by the New Investigator Fund from HHS.
He obtained his MD and PhD degrees from the University of Ioannina in Greece. After finishing his training in neurology, he completed a research fellowship at the Ruhr University of Bochum in Germany granted by the European Academy of Neurology. Aristeidis has actively participated in numerous research projects and international collaborations and serves in the editorial board of several academic medical journals, including Stroke.
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.
Kevin Reeh
Project Manager
Kevin Reeh
Project Manager
Kevin Reeh has worked in research since 2008; starting with PHRI in 2014, Kevin began with the COMPASS trial study team. Kevin continues to coordinate global randomized multicenter trials in his current role with ENRICH-AF. Kevin has bachelor degrees in the Biological Sciences and Health Sciences, as well as a Masters of Science.
Canadian Institutes of Health Research (CIHR)
ongoing
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