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

Study acronym: CoVasc-ICH2
StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: May 30, 2026 to Sep 30, 2026v4
  2. Notable Start date: Jun 30, 2025 to May 30, 2026 Primary completion date: Jun 30, 2028 to Jul 30, 2028 · Completion date: Jun 30, 2028 to Oct 30, 2028v3 Show 2 more changesShow less
    • Primary completion date: Jun 30, 2028 to Jul 30, 2028
    • Completion date: Jun 30, 2028 to Oct 30, 2028
  3. Notable Start date: Dec 1, 2024 to Jun 30, 2025 Primary completion date: Dec 1, 2028 to Jun 30, 2028 · Completion date: Apr 30, 2029 to Jun 30, 2028v2 Show 2 more changesShow less
    • Primary completion date: Dec 1, 2028 to Jun 30, 2028
    • Completion date: Apr 30, 2029 to Jun 30, 2028
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06587737
Lead Sponsor Population Health Research Institute
Conditions Colchicine, ICH - Intracerebral Hemorrhage, Stroke, Dependence
Enrollment 1,125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov