Trials / Completed
CompletedNCT05159219
Colchicine for the Prevention of Vascular Events After an Acute Intracerebral Hemorrhage
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- Population Health Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Colchicine Pill | Anti-inflammatory |
| OTHER | Placebo | Inert ingredients |
Timeline
- Start date
- 2022-08-04
- Primary completion
- 2024-12-03
- Completion
- 2024-12-03
- First posted
- 2021-12-16
- Last updated
- 2025-01-16
Locations
11 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT05159219. Inclusion in this directory is not an endorsement.