COL BE PCI: COLchicin in BElgium bei Patienten mit koronarer Herzkrankheit nach perkutaner Koronarintervention (KCE-211324)

COLchicine in BElgium in patients with coronary artery disease after Percutaneous Coronary Intervention (COL BE PCI)

Participants (P)

Patients ≥45 years with coronary artery disease (CAD), treated with percutaneous coronary intervention (PCI), with at least one additional cardiovascular risk factor as identified by theSMART (Second Manifestations of Arterial Disease) risk score: age ≥60-year, diabetes mellitus, smoking, hypertension, high cholesterol, hsCRP ≥2 mg/dl and CCS, kidney insufficiency, history of vascular disease (CAD, stroke, PAD, AAA), able to be enrolled/randomized between 2 hour and 5 days post PCI.

Intervention (I)

Low dose colchicine 0.5 mg daily, currently available in Belgium. Therapy will be started in-hospital and continued daily for the duration of the trial (±3,7 years).

Control (C)

Matching placebo.

Outcome (O)

Time from randomisation to first occurrence of a composite endpoint consisting of: all-cause death, spontaneous non-fatal myocardial infarction, non-fatal stroke, or ischemia-driven coronary revascularization.

Trial Design

Randomized, double blind, placebo-controlled, pragmatic and comparative-effectiveness trial, with patient centred outcomes.

After signing the informed-consent form, eligible patients will be randomly assigned in a 1:1 ratio to receive 0.5 mg of colchicine once daily or matching placebo.

Sample Size

2770 patients

Trial duration

47 months

Budget

5.37 MIO

18 sites