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 Type

Interventional - Drug

Study Design

Double-blind vanguard randomized placebo-controlled Phase II pilot

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2022 - 2024



Canadian Institutes of Health Research (CIHR)

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