NCT06587737

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

A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,125 (estimated)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colchicine
• ICH - Intracerebral Hemorrhage
• Stroke
• Dependence

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 MG	colchicine 0.5mg once-daily
DRUG	Placebo	matching placebo, lacking active ingredient, once-daily

Timeline

• Start date: 2026-05-30
• Primary completion: 2028-07-30
• Completion: 2028-10-30
• First posted: 2024-09-19
• Last updated: 2026-02-25