WSC 2026 | CoVasc-ICH 2: lessons from the pilot trial to inform Phase III study design
Aristeidis Katsanos, MD, PhD, McMaster University, Hamilton, Canada, shares learnings from the pilot CoVasc-ICH trial (NCT05159219) that shaped the design of the Phase III CoVasc-ICH 2 trial (NCT06587737). CoVasc-ICH showed that testing colchicine in an acute intracerebral hemorrhage (ICH) population is feasible, but had a high rate of discontinuation due to the severity of the ICH. Dr Katsanos explains that the new CoVasc-ICH 2 study will focus on patients with less severe symptoms and smaller ICH volumes to minimize early discontinuation of colchicine or placebo. This interview took place at the 18th World Stroke Congress (WSC) in Seoul, Korea.
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Transcript
During the pilot CoVasc-ICH study, we did see that it’s feasible to test colchicine in an acute ICH population. The interesting finding is that there was an unexpectedly high rate of discontinuation for colchicine. And analyzing the data, we didn’t see a difference between the colchicine or the placebo arms, and we see that the pattern was exactly the same. So analyzing the data a little bit more, we did understand that the probability of discontinuation has to do with the severity of the ICH...
During the pilot CoVasc-ICH study, we did see that it’s feasible to test colchicine in an acute ICH population. The interesting finding is that there was an unexpectedly high rate of discontinuation for colchicine. And analyzing the data, we didn’t see a difference between the colchicine or the placebo arms, and we see that the pattern was exactly the same. So analyzing the data a little bit more, we did understand that the probability of discontinuation has to do with the severity of the ICH. The more severe patients, they stop the medication because they’re not doing well, and some of them, they focus on palliation, right? So in the new ICH study that we’re doing, CoVasc-ICH 2, so we are limiting to patients that they have less severity and their presentation in terms of symptoms and also smaller ICH volumes. And the reason we’re doing that is not because of safety, but to make sure that those people will not go on to discontinue the colchicine or the placebo early on into the trial.
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