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

NCT06587737 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1125

Last updated 2026-02-25

No results posted yet for this study

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

DRUG

Colchicine 0.5 MG

colchicine 0.5mg once-daily

DRUG

Placebo

matching placebo, lacking active ingredient, once-daily

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Aristeidis Katsanos, MD · Population Health Research Institute, Hamilton Health Sciences, McMaster University

  • Ashkan Shoamanesh, MD · Population Health Research Institute, Hamilton Health Sciences, McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06587737 on ClinicalTrials.gov