Old drug, new trick: colchicine may shield hearts during surgery
NCT ID NCT05618353
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether colchicine, an inexpensive anti-inflammatory drug used for gout, can prevent heart attacks, strokes, and death in heart disease patients undergoing major surgery. Researchers will give the drug to 700 veterans before and after their operation. The goal is to see if calming inflammation can lower the risk of serious heart complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 700 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Birmingham VA Medical Center, Birmingham, AL
RECRUITINGBirmingham, Alabama, 35233-1927, United States
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Durham VA Medical Center, Durham, NC
RECRUITINGDurham, North Carolina, 27705-3875, United States
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Louis Stokes VA Medical Center, Cleveland, OH
RECRUITINGCleveland, Ohio, 44106-1702, United States
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Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITINGHouston, Texas, 77030-4211, United States
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North Florida/South Georgia Veterans Health System, Gainesville, FL
RECRUITINGGainesville, Florida, 32608-1135, United States
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VA Long Beach Healthcare System, Long Beach, CA
RECRUITINGLong Beach, California, 90822, United States
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VA NY Harbor Healthcare System, New York, NY
RECRUITINGNew York, New York, 10010-5011, United States
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VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITINGDallas, Texas, 75216-7167, United States
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VA Western New York Healthcare System, Buffalo, NY
RECRUITINGBuffalo, New York, 14215-1129, United States
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Other studies related to the condition(s) this trial covers.
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- A soft patch that watches your heart beat in real time
- Zapping the ear: a new way to stop Post-Surgery heart rhythm problems?
- Squeeze a ball, lower your blood pressure? heart trial puts handgrip exercise to the test
- New heart scan aims to spot hidden plaque before it strikes
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?