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Using colchicine to reduce heart complications after major surgery in patients with coronary artery disease

Impact of Colchicine on Peri-Operative Major Adverse Cardiovascular Events in Patients With Prior Coronary Revascularization

Phase 4 Interventional VA Office of Research and Development · NCT05618353

This study is testing if colchicine can help prevent heart problems after major surgery in people with coronary artery disease.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorVA Office of Research and Development Federal
Locations9 sites (Birmingham, Alabama and 8 other locations)
Trial IDNCT05618353 on ClinicalTrials.gov

What this trial studies

This trial investigates the effects of colchicine, an anti-inflammatory medication, on reducing major adverse cardiovascular events in patients with coronary artery disease undergoing high-risk surgeries. It aims to understand how inflammation contributes to heart damage post-surgery and whether colchicine can mitigate these risks. The study includes patients with a history of coronary revascularization or significant coronary artery disease who are scheduled for intermediate- or high-risk surgical procedures. Participants will be randomly assigned to receive either colchicine or a placebo to evaluate the medication's efficacy in preventing complications.

Who should consider this trial

Good fit: Ideal candidates are men and women with a history of coronary revascularization or severe coronary artery disease who are referred for high-risk surgeries.

Not a fit: Patients who have used colchicine within the past month or have a history of colchicine intolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly lower the risk of heart attacks, strokes, and death in patients undergoing major surgery.

How similar studies have performed: Previous studies have shown promising results with colchicine in reducing cardiovascular events, indicating potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Men and women with

* Prior coronary revascularization (via PCI or coronary artery bypass graft surgery) or high coronary atherosclerotic burden (\>70% let main disease or \>80% disease in the proximal or mid LAD, prox Cx, or prox or mid RCA on coronary angiography), AND
* Referred for intermediate- or high-risk surgery (general abdominal or intraperitoneal surgery, neurosurgery, suprainguinal surgery, peripheral vascular surgery, thoracic surgery).
* If planned for only a laparoscopic or endovascular approach (this includes a minimally invasive hybrid approach such as transcarotid artery revascularization), at least one component of the Revised Cardiac Risk Index score (history of myocardial infarction, history of congestive heart failure, history of transient ischemic attack or stroke, pre-operative use of insulin, pre-operative creatinine \>2 mg/dL) should be present.

Exclusion Criteria:

* Colchicine use within one month or history of colchicine intolerance
* Inflammatory bowel disease with history of diarrhea as presentation or chronic diarrhea
* Pre-existent progressive neuromuscular disease

  * amyotrophic lateral sclerosis
  * hereditary muscular disorders
  * myositis
  * necrotizing myopathy
  * myasthenia gravis
  * lambert-eaton syndrome
* Glomerular filtration rate \<30mL/minute or on dialysis
* History of cirrhosis, chronic active hepatitis or severe hepatic disease
* History of myelodysplasia with current evidence of cytopenia
* Active infection defined as fever \>100.4oF or antibiotic use with white blood cell count greater than the upper limit of normal or lower than the lower limit of normal within 24 hours of randomization (major confounder with increased inflammatory markers)
* Undergoing immunosuppressive or immunostimulatory chemo or biologic therapy
* Pregnant (as confirmed by urine or serum test), nursing, or planning to become pregnant during study participation
* Participating in a competing study or unable to consent
* Any significant condition or situation that may put the participant at higher risk, confound the study results, or interfere with adherence to study procedures
* Patients on strong CYP3A4 and/or P-glycoprotein inhibitors (e.g., ritonavir, clarithromycin, diltiazem, verapamil) at baseline will also be excluded due to potential drug interactions

  * However, if one of these medications are started during the post-operative study period, dose adjustments will be made per drug package insert
  * Participants will also be instructed not to drink grapefruit juice while on study drug

Where this trial is running

Birmingham, Alabama and 8 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseCoronary artery diseaseNon-cardiac surgeryColchicineInflammationMajor adverse cardiovascular events
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.