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
Senior Scientist
Ashkan Shoamanesh
Senior Scientist
Ashkan Shoamanesh is an Associate Professor of Medicine (Div. of Neurology) and a stroke neurologist at McMaster University, where he holds the Marta and Owen Boris Chair in Stroke Research and Care. He is the founding Director of the Hemorrhagic Stroke Research Program and a Senior Scientist at the Population Health Research Institute in Hamilton, Canada. Shoamanesh’s clinical trials program focuses on advancing treatment and establishing new standards of care to prevent stroke or reduce stroke-related death and disability. He is the principal investigator (PI) or Co-PI of multiple international multicentre randomized trials, including ENRICH-AF (NCT03950076; Lancet 2023), OCEANIC-STROKE (NCT05686070), SATURN-MRI (NCT03936361) and CoVasc-ICH (NCT05159219). He has also held central leadership roles in the ANNEXa-I (NEJM 2024), PACIFIC-STROKE (Lancet 2022) and NAVIGATE-ESUS (NEJM 2018) trials. Shoamanesh is the founding Chair of the Canadian Hemorrhagic Stroke Trials Initiative (CoHESIVE; www2.phri.ca/CoHESIVE) and was the lead author of the first Canadian Stroke Best Practice Recommendations on the Management of Spontaneous Intracerebral Hemorrhage.
Shoamanesh has published over 170 peer-reviewed manuscripts in top-tier scientific journals. He serves on the editorial boards of Stroke, the International Journal of Stroke, and the Canadian Journal of Neurological Sciences. He is an active contributor to international scientific meetings and previously co-chaired the World Stroke Congress (World Stroke Organization) and the World Intracranial Hemorrhage Conference.
His research program receives funding from several bodies, including the Canadian Institutes of Health Research, National Institutes of Health, Heart and Stroke Foundation of Canada, Brain Canada, the Australian Government Medical Research Future Fund, British Heart Foundation, and multiple industry partners. His contributions have been recognized with numerous accolades from international organizations, such as the American Academy of Neurology (Pessin Award), American Heart/Stroke Association (Globus Award, Siekert Award, Dudley White Award), American Neurological Association (Denny-Brown Award), European Stroke Organization (Young Investigator Award, Scientific Excellence Award), Heart and Stroke Foundation of Canada (National New Investigator Award, Barnett Scholarship) and the World Stroke Organization (Future Leaders Program).
Aristeidis Katsanos
Investigator
Aristeidis Katsanos
Investigator
Aristeidis Katsanos, MD, PhD is a Vascular Neurologist, Assistant Professor at the McMaster University and Investigator at the Population Health Research Institute, Hamilton, ON, Canada. His research focuses on emerging neurosonology applications and the evidence-based evaluation of novel therapies in acute stroke treatment and secondary stroke prevention.
He has published more than 250 papers in high-impact medical journals to date and currently serves as the Co-PI of two phase 2 randomized controlled clinical trials evaluating optimal blood pressure control after endovascular thrombectomy (DETECT; NCT04484350) and the use of colchicine for the prevention of vascular events after an acute intracerebral hemorrhage (CoVasc-ICH; NCT05159219).
He received the Young Investigator Award from the European Stroke Organisation, New Investigator Award from the Heart & Stroke Foundation Canada and the EJ Moran Campbell Award from the Department of Medicine, McMaster University. He serves as an Academic Editor for PLoS One, Associate Editor for Frontiers in Neurology, and Assistant Editor for 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 more than 15 years experience in academic research. He has been at PHRI since 2014, and has been involved in the coordination of large, multicenter international clinical trials, as well as pilot/feasibility studies. These project include industry-sponsored, and investigator-initiated with industry and/or grant funding.
He has Bachelor degrees in the Biological Sciences and Health Sciences from Brock University, as well as a Masters of Science from Dalhousie University.
Canadian Institutes of Health Research (CIHR)
ongoing
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