Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage (CoVasc-ICH)

A Vanguard, Double-blind, Randomized, Placebo-controlled, Phase 2 Pilot Study to Investigate Prevention of Cardiovascular Events with Oral Colchicine 0.5mg Once Daily Compared with Placebo in Participants with Spontaneous ICH and Established, or Risk Factors For, Atherosclerosis

The overall goal is to establish the safety and efficacy of colchicine in ICH patients for the prevention of major cardiovascular events and brain injury. Colchicine for the prevention of vascular events after an acute intracerebral hemorrhage (CoVasc-ICH) is a vanguard pilot trial designed to obtain the factual feasibility prerequisites essential for the planning, design, funding and execution of a subsequent phase III trial.

Study Overview

• Status: Completed
• Conditions: Intracranial Hemorrhages
• Intervention / Treatment: Drug: Colchicine Pill; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary, Foothills Medical Centre
    • Edmonton, Alberta, Canada
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Hospital, Hamilton Health Sciences
    • Kingston, Ontario, Canada
      • Kingston General Hospital, Kingston Health Sciences
    • London, Ontario, Canada
      • London Health Science Centre, University Hospital
    • Ottawa, Ontario, Canada
      • Ottawa Hospital Research Institute
    • Toronto, Ontario, Canada
      • Toronto Western Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Hospital
  • Quebec
    • Montréal, Quebec, Canada
      • University of Montreal
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada
      • University of Saskatchewan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Adult participants are eligible to be included in the study only if all of the following criteria apply:

Type of Participant and Disease Characteristics

1. Participants with documented spontaneous intraparenchymal hemorrhage within 48 hours of symptom onset (or last seen normal) and

2. 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)

   Informed Consent

3. Capable of giving signed informed consent either independently, or by a legally authorized representative (LAR), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions

1. Secondary causes of ICH (relating to trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
2. Inflammatory bowel disease or chronic diarrhea
3. Cirrhosis or severe hepatic dysfunction

4. Renal insufficiency (eGFR <15mL/min)

   Prior/Concomitant Therapy

5. Concurrent 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)
6. Known allergy or sensitivity to colchicine

7. Strong indication for colchicine where assignment to placebo is deemed unacceptable

   Other Exclusions

8. Pregnant or breast-feeding
9. Inability to adhere to study procedures
10. Estimated life expectancy less than 6 months at the time of enrollment
11. Close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site)

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: Oral matching placebo, once daily; Matching placebo tablet	Other: Placebo; Inert ingredients
Experimental: Oral Colchicine, 0.5mg once daily; Active colchicine tablet	Drug: Colchicine Pill; Anti-inflammatory

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Recruitment	Recruitment Rate, mean of approximately 10 participants per site, per year	From site activation until the end of recruitment (approximately 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Refusal Rate	Refusal to participate is not a substantial barrier to recruitment	Exploratory, from first patient, first visit, until the common study end date (approximately 30 months)
Feasibility - Retention Rate	Retention of ≥90% of study participants	At 6 months from randomization
Feasibility - Medication Adherence	Adherence >75%	At 12 months from randomization

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Wilkinson CM, Katsanos AH, Sander NH, Kung TFC, Colbourne F, Shoamanesh A. Colchicine pre-treatment and post-treatment does not worsen bleeding or functional outcome after collagenase-induced intracerebral hemorrhage. PLoS One. 2022 Oct 18;17(10):e0276405. doi: 10.1371/journal.pone.0276405. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2022
• Primary Completion (Actual): December 3, 2024
• Study Completion (Actual): December 3, 2024

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 13, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Colchicine; Intracranial Hemorrhage
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hemorrhage; Intracranial Hemorrhages; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Gout Suppressants; Antirheumatic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Colchicine
• Other Study ID Numbers: CoVasc-ICH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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