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

NCT06095765 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2770

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital, Ghent

    collaborator OTHER

  • Belgium Health Care Knowledge Centre

    collaborator OTHER_GOV

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2027-11-01
Completion
2028-03-01

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095765 on ClinicalTrials.gov