About this trial
Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors.
The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.
Eligibility criteria
Qualifiers
None
Disqualifiers
secondary causes of ICH (such as trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
ICH volume more than 60ml in the last imaging scan prior to consent
Glasgow Coma Scale (GCS) score less than 7 or being intubated at the time of consent
inflammatory bowel disease or chronic diarrhea
Trial design
Treatments tested in this trial
- Colchicine 0.5 MG
- Placebo