drugset / Trial / NCT06587737

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

NCT06587737

Phase 3 Not yet recruiting 1125 enrolled Population Health Research Institute
RandomizedParallel-groupQuadruple-blindPrevention

Summary

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.

Timeline

Start
2026-05-30
Primary completion
2028-07-30
Completion
2028-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 0.5 mg Oral