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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45+
SponsorAZ Sint-Jan AV

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥45 years.

Age ≥ year

Diabetes mellitus, on treatment or new diagnosis with HbA1c ≥6.5%

Current smoking

Disqualifiers

Women who are pregnant, breastfeeding, or of childbearing potential who are not using an effective method of contraception. Or women who intend to donate oocytes.

Men who plan to father children during the study period or who are unwilling to use effective forms of contraception. Or men who intend to donate sperm.

Any contraindication or known intolerance to colchicine.

Chronic use of -or need for- colchicine.

Trial design

Treatments tested in this trial

  • Colchicine 0.5 MG Oral Tablet
  • Placebo

Treatment groups

2,770 Participants
are divided into 2 treatment groups

Sponsors and collaborators

AZ Sint-Jan AV

Lead sponsor

University Hospital, Ghent

Collaborator

Belgium Health Care Knowledge Centre

Collaborator