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Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention

Study acronym: COL BE PCI
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Eligibility criteria revised
    • Site details revised at 4 of 19 sites
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 1, 2028 to Nov 1, 2027
    • Start date changed from estimate of Feb 1, 2024 to Jan 29, 2024
    • Study sites revised (19)
    v3
  3. Secondary endpoints: 7 to 8v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main aim of this trial is to determine whether there are fewer cardiovascular events when patients with coronary artery disease take a low dose of colchicine of 0.5 mg daily on top of optimal standard treatment after treatment with PCI, compared with placebo in combination with optimal standard treatment. More specifically, we aim to investigate the benefits of a daily low dose of colchicine in patients with coronary artery disease after treatment with PCI, to confirm that a daily low dose of colchicine helps prevent additional incidents in coronary artery disease, and to identify a subgroup of patients with CAD who are at increased risk for cardiovascular events and could benefit most from colchicine.
Trial Details
NCT Number NCT06095765
Lead Sponsor AZ Sint-Jan AV
Collaborators: University Hospital, Ghent, Belgium Health Care Knowledge Centre
Conditions
(from sponsor)		 Coronary Artery Disease
Related terms Coronary Artery Disease
Enrollment 2,770 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov