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

Phase 2

Completed

• Conditions: Intracranial Hemorrhages
• Interventions: Drug: Colchicine Pill; Other: Placebo

• Registration Number: NCT05159219
• Lead Sponsor: Population Health Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-13
• Study First Posted: 2021-12-16
• Study Start: 2022-08-04
• Primary Completion: 2024-12-03
• Study Completion: 2024-12-03
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Colchicine, 0.5mg once daily	Colchicine Pill	Active colchicine tablet
Oral matching placebo, once daily	Placebo	Matching placebo tablet

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (11)

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 Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Calgary, Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

Ottawa Hospital Research Institute; 🇨🇦 Ottawa, Ontario, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Montreal; 🇨🇦 Montréal, Quebec, Canada

Sunnybrook Hospital; 🇨🇦 Toronto, Ontario, Canada

Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada