Low-dose Colchicine for CABG Graft Failure Prevention

ConditionsCAD - Coronary Artery Disease CABG Colchicine

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeijing Anzhen Hospital

About this trial

This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be male or female, aged 18 years or older;

Within 3 days after successful isolated coronary artery bypass grafting (CABG);

Sign informed consent;

Disqualifiers

Severe valvular heart disease requiring concomitant or staged valvular surgery;

History of non-skin cancer in the past 3 years;

Inflammatory bowel disease or chronic diarrhea;

Neuromuscular diseases or non-transient creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);

Trial design

Design model

Parallel

Treatments tested in this trial

Colchicine Pill
Drug
Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.
Placebo
Drug
Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months.

Treatment groups

622 Participants

are divided into 2 treatment groups

Group A: Colchicine groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

graft failure rate

At 24 months postoperatively, all patients who complete the study will undergo coronary computed tomographic angiography (CCTA) to assess graft patency, calculated as 1 minus graft failure rate, where graft failure rate = (number of grafts graded B or O according to the Fitzgibbon classification / total number of grafts) × 100%.

Time frame

2 year after randomization

Secondary outcomes

MACCE

Major adverse cardiovascular and cerebrovascular events include cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operating-related) myocardial infarction, readmission for acute coronary syndrome, and Coronary revascularization

Time frame

2 year after randomization

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: