Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage (CoVasc-ICH2)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Dependence; ICH - Intracerebral Hemorrhage; Colchicine
• Intervention / Treatment: Drug: Colchicine 0.5 MG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1125
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Kevin W Reeh, MSc; Phone Number: 905-521-2100; Email: CoVasc-ICH2@phri.ca
• Study Contact Backup: Name: Amanda Taylor, BSc; Email: CoVasc-ICH2@phri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adult patients presenting with spontaneous intraparenchymal hemorrhage within 72 hours of symptom onset and qualifying for at least one of the following categories:

i. history of symptomatic coronary, peripheral and/or carotid artery disease (severe atherosclerotic vascular disease), or ii. visualized extracranial cervical/intracranial atherosclerotic disease causing any degree of stenosis/occlusion or presence of aortic arch plaque with maximum thickness ≥1 mm (moderate atherosclerotic vascular disease), or iii. two or more risk factors including: age 60 years or older, hypertension, dyslipidemia, diabetes mellitus, chronic kidney disease (eGFR: 15-50mL/min), history of ischemic stroke or current smoking (mild atherosclerotic vascular disease).

Exclusion Criteria:

• 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
• cirrhosis or severe hepatic dysfunction
• renal insufficiency (eGFR<15mL/min)
• concurrent or planned treatment with strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-gp inhibitors (cyclosporine, ranolazine)
• pregnancy or breast-feeding
• known allergy or sensitivity to colchicine
• a strong indication for colchicine where assignment to placebo is deemed unacceptable
• estimated life expectancy less than 6 months at the time of enrollment, and
• inability to adhere to study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; matching placebo, lacking active ingredient, once-daily
Experimental: colchicine 0.5mg OD	Drug: Colchicine 0.5 MG; colchicine 0.5mg once-daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: MACE and Dependency	Treatment with colchicine will reduce the risk for major adverse cardiovascular events (MACE) and dependency	through study completion, an average of 36 months
Safety: Symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates	There will be no clinically-important change in symptomatic hematoma expansion, major gastrointestinal adverse reactions or infection rates with oral colchicine 0.5mg OD compared with matching placebo	through study completion, an average of 36 months

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Aristeidis Katsanos, MD, Population Health Research Institute, Hamilton Health Sciences, McMaster University; Principal Investigator: Ashkan Shoamanesh, MD, Population Health Research Institute, Hamilton Health Sciences, McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Pathological Conditions, Signs and Symptoms; Stroke; Cerebral Hemorrhage; Heterocyclic Compounds; Alkaloids; Colchicine
• Other Study ID Numbers: CoVasc-ICH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No