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

NCT06587737 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CoVasc-ICH2
• Study Type: interventional
• Target: 1,125
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

colchicine 0.5mg OD

EXPERIMENTAL

Drug: Colchicine 0.5 MG

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Colchicine 0.5 MG DRUG

colchicine 0.5mg once-daily

colchicine 0.5mg OD

Placebo DRUG

matching placebo, lacking active ingredient, once-daily

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin W Reeh, MSc

CONTACT

905-521-2100; CoVasc-ICH2@phri.ca

Amanda Taylor, BSc

CONTACT

CoVasc-ICH2@phri.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, randomized, placebo-controlled, phase III study

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): October 30, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02