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

Intracranial Hemorrhages Clinical Trial

— CoVasc-ICH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05159219
• Other study ID #: CoVasc-ICH
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 4, 2022
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

Intervention

Drug:
• Colchicine Pill
Anti-inflammatory

Other:
• Placebo
Inert ingredients

Locations

Country	Name	City	State
Canada	University of Calgary, Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
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	University of Montreal	Montréal	Quebec
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario
Canada	University of Saskatchewan	Saskatoon	Saskatchewan
Canada	Sunnybrook Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Feasibility - Retention Rate	Retention of =90% of study participants	At 6 months from randomization
Secondary	Feasibility - Medication Adherence	Adherence >75%	At 12 months from randomization