Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage

NCT05159219 | Completed Phase 2 DMC

• 1 other identifier: CoVasc-ICH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Intracranial Hemorrhages

Keywords

Intracranial Hemorrhage; Colchicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Feasibility - Refusal Rate

  Exploratory, from first patient, first visit, until the common study end date (approximately 30 months)

• Feasibility - Retention Rate

  At 6 months from randomization

• Feasibility - Medication Adherence

  At 12 months from randomization

Study Arms (2)

Oral Colchicine, 0.5mg once daily

EXPERIMENTAL

Active colchicine tablet

Drug: Colchicine Pill

Oral matching placebo, once daily

PLACEBO COMPARATOR

Matching placebo tablet

Other: Placebo

Interventions

Colchicine Pill DRUG

Anti-inflammatory

Oral Colchicine, 0.5mg once daily

Placebo OTHER

Inert ingredients

Oral matching placebo, once daily

Eligibility Criteria

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

You may qualify if:

• Adult participants are eligible to be included in the study only if all of the following criteria apply:
• Type of Participant and Disease Characteristics
• Participants with documented spontaneous intraparenchymal hemorrhage within 48 hours of symptom onset (or last seen normal) 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)
• Informed Consent
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Medical Conditions
• Secondary causes of ICH (relating to trauma, macrovascular anomalies, neoplasms or bleeding diathesis)
• Inflammatory bowel disease or chronic diarrhea
• Cirrhosis or severe hepatic dysfunction
• Renal insufficiency (eGFR \<15mL/min)
• Prior/Concomitant Therapy
• 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)
• Known allergy or sensitivity to colchicine
• Strong indication for colchicine where assignment to placebo is deemed unacceptable
• Pregnant or breast-feeding
• Inability to adhere to study procedures
• Estimated life expectancy less than 6 months at the time of enrollment
• 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)

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (11)

University of Calgary, Foothills Medical Centre

Calgary, Alberta, Canada

Location

University of Alberta

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Hamilton General Hospital, Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Kingston General Hospital, Kingston Health Sciences

Kingston, Ontario, Canada

Location

London Health Science Centre, University Hospital

London, Ontario, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

Sunnybrook Hospital

Toronto, Ontario, Canada

Location

Toronto Western Hospital

Toronto, Ontario, Canada

Location

University of Montreal

Montreal, Quebec, Canada

Location

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 36256671 DERIVED

MeSH Terms

Conditions

Intracranial Hemorrhages

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

  PRINCIPAL INVESTIGATOR

• Ashkan Shoamanesh, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational product, with matching placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility, double-blind, placebo-controlled randomized controlled trial (RCT)

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 16, 2021
• Study Start: August 4, 2022
• Primary Completion: December 3, 2024
• Study Completion: December 3, 2024
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)