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Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage
Sponsor: Population Health Research Institute
Summary
Data indicate that patients with intracerebral hemorrhage (ICH) are at high risk for thromboembolic events and disability that is not being sufficiently mitigated by current treatment strategies. This is aggravated by the cessation of antithrombotic medications for significant periods after hemorrhage. These findings highlight the need for novel treatments that modify the high risk for major vascular events and functional outcomes in ICH survivors. The objective of CoVasc-ICH 2 is to demonstrate that oral colchicine 0.5 mg daily is superior to placebo for improving the outcomes of ICH survivors with evidence or risk factors for atherosclerosis, when started within 72 hours from ICH onset.
Official title: A Double-blind, Randomized, Placebo-controlled, Phase III Study for Reducing Dependency and Cardiovascular Events With Oral Colchicine 0.5mg Once Daily Compared With Placebo in Participants With Spontaneous Intracerebral Hemorrhage and Established, or Risk Factors for, Atherosclerosis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1125
Start Date
2026-05-30
Completion Date
2028-10-30
Last Updated
2026-02-25
Healthy Volunteers
No
Interventions
Colchicine 0.5 MG
colchicine 0.5mg once-daily
Placebo
matching placebo, lacking active ingredient, once-daily