Grant: Team Gr.: Interv. Trial in Inflam. for Chronic Cond. - Res. Teams Gr. - General

Our study (CoVasc-ICH) aims to improve the health of people who survive a stroke due to bleeding in the brain, known as "hemorrhagic stroke". Hemorrhagic strokes happen when weakened blood vessels rupture and cause bleeding in the brain. This is the stroke type that causes the greatest disability. Patients with hemorrhagic stroke also have a 1 in 10 risk each year of suffering 'major cardiovascular events' due to clotting (like a heart attack or stroke) or bleeding (like another brain bleed). Colchicine is a drug that has been used for decades in various other medical conditions. It is well tolerated and safe. Recently colchicine was found to reduce clotting by reducing inflammation, in a manner that does not increase bleeding. In animal models colchicine was also found to reduce brain inflammation. These properties make colchicine an attractive drug for patients with hemorrhagic stroke. CoVasc-ICH aims to test whether colchicine can reduce the risk of clotting and disability without increasing the risk of re-bleeding after a hemorrhagic stroke. It will be a type of experiment known as a 'randomized controlled trial.' Randomized controlled trials are the most reliable tests of treatments. We will include patients with a hemorrhagic stroke occurring within 48 hours. These patients will be assigned at random, with a 50:50 chance of either receiving daily low-dose colchicine or placebo. We will provide study medication (colchicine or placebo) and follow patients for an average of two years. During this time patients will be monitored for bleeding, clotting and disability. We are currently doing the trial in 11 hospitals in Canada and planning to move to an international trial, which will involve approximately 90 hospitals in 9 countries. As an intermediate step we are proposing to first expand our study into 2 additional countries. This will help us refine our methods by gathering more data outside of Canada and have a smooth transition to a full international trial.