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

NCT ID: NCT05159219

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-04
• Study Completion Date: 2024-12-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Colchicine, 0.5mg once daily

Active colchicine tablet

Group Type: EXPERIMENTAL

Colchicine Pill

Intervention Type: DRUG

Anti-inflammatory

Oral matching placebo, once daily

Matching placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Inert ingredients

Interventions

Colchicine Pill

Anti-inflammatory

Intervention Type: DRUG

Placebo

Inert ingredients

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aristeidis Katsanos, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Ashkan Shoamanesh, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

University of Calgary, Foothills Medical Centre

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

Hamilton General Hospital, Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston General Hospital, Kingston Health Sciences

Kingston, Ontario, Canada

London Health Science Centre, University Hospital

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sunnybrook Hospital

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

University of Montreal

Montreal, Quebec, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36256671 (View on PubMed)

Other Identifiers

CoVasc-ICH

Identifier Type: -

Identifier Source: org_study_id