NCT06095765

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

Colchicine in Belgium in Patients With Coronary Artery Disease

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,770 (estimated)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, randomised, double-blind, multicenter, placebo-controlled phase III pragmatic superiority trial comparing colchicine 0.5 mg with placebo administered orally once-daily in up to 2770 participants with CAD treated with PCI. Participants will be randomised in a 1:1 ratio to receive either colchicine 0.5 mg or placebo as an adjunct to standard of care. The trial is event driven with trial closure being performed when the targeted number of 566 primary endpoint events has been reached. Participants will be seen by the site staff 1 month after randomisation and thereafter every 12 months as per standard of care (SOC) and for IMP dispense and compliance, completing questionnaires and outcome event assessment until end of study. After the first month, a telephone visit will be scheduled every 6 months in between two standard of care on-site visits.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Colchicine 0.5 MG Oral Tablet	Oral intake of 0.5 mg colchicine once daily
DRUG	Placebo	Oral intake of matching placebo once daily

Timeline

• Start date: 2024-01-29
• Primary completion: 2027-11-01
• Completion: 2028-03-01
• First posted: 2023-10-23
• Last updated: 2024-03-08

Locations

19 sites across 1 country: Belgium