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

Sponsor
Population Health Research Institute
Study ID
NCT06587737
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Colchicine
  • Dependence
  • ICH - Intracerebral Hemorrhage
  • Stroke

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Colchicine 0.5 MG — DRUG
    colchicine 0.5mg once-daily
  • Placebo — DRUG
    matching placebo, lacking active ingredient, once-daily

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Jul 30, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
1,125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: colchicine 0.5mg OD
  • Placebo Comparator: placebo

Primary Outcome Measure

Efficacy: MACE and Dependency [ Time Frame: through study completion, an average of 36 months ]

Central Contacts

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