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NOT YET RECRUITING
NCT06587737
PHASE3

Colchicine for the Reduction of Dependency and Vascular Events After an Acute Intracerebral Hemorrhage

Sponsor: Population Health Research Institute

View on ClinicalTrials.gov

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

DRUG

Colchicine 0.5 MG

colchicine 0.5mg once-daily

DRUG

Placebo

matching placebo, lacking active ingredient, once-daily