Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

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

Treatment groups

1,125 Participants
are divided into 2 treatment groups

Locations

This trial has no locations