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ESOC 2025 | Findings from the CoVasc-ICH trial and looking forward to CoVasc-ICH 2

Aristeidis Katsanos, MD, McMaster University, Hamilton, Ontario, Canada, comments on the CoVasc-ICH (NCT05159219) pilot Phase II randomized clinical trial assessing colchicine after intracerebral hemorrhage (ICH). He highlights that the study proved feasibility and identified no major safety concerns, laying the groundwork for the planned Phase III CoVasc-ICH 2 (NCT065877370) trial. This trial aims to enroll approximately 1,200 participants and assess the safety and efficacy of colchicine in patients with acute ICH. This interview took place at the 11th European Stroke Organisation Conference (ESOC) in Helsinki, Finland.

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Transcript

So, CoVasc-ICH was a pilot Phase II randomized clinical trial assessing colchicine after intracranial hemorrhage. So, in fact, it was the first study ever made to address the question whether colchicine is safe and whether it’s feasible to do a study testing colchicine after acute intracerebral hemorrhage. So, CoVasc-ICH was performed in 11 centers throughout Canada and what we’re able to prove is that it’s feasible so we’re able to recruit 100 patients with a recruitment rate of approximately 9 patients per center per year and also we didn’t identify any major safety concerns...

So, CoVasc-ICH was a pilot Phase II randomized clinical trial assessing colchicine after intracranial hemorrhage. So, in fact, it was the first study ever made to address the question whether colchicine is safe and whether it’s feasible to do a study testing colchicine after acute intracerebral hemorrhage. So, CoVasc-ICH was performed in 11 centers throughout Canada and what we’re able to prove is that it’s feasible so we’re able to recruit 100 patients with a recruitment rate of approximately 9 patients per center per year and also we didn’t identify any major safety concerns. We also did some analysis on the major adverse cardiovascular events but, of course, all these are very exploratory and all the work that we did in CoVasc-ICH lays the background and also it will be very useful in planning the next phase of our study. So the next study is going to be CoVasc 2 and you know as a continuation of the pilot study. It’s going to be an international Phase III clinical trial done in North America, Europe, and Asia and we’re hoping to enroll approximately 1200 participants and in CoVasc 2 we’re going to be testing the safety and efficacy of colchicine in patients with acute ICH.

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Disclosures

PI: CoVasc-ICH.