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Old drug, new trick: colchicine may shield hearts during surgery

NCT ID NCT05618353

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Birmingham VA Medical Center, Birmingham, AL

    RECRUITING

    Birmingham, Alabama, 35233-1927, United States

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    RECRUITING

    Cleveland, Ohio, 44106-1702, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    RECRUITING

    Houston, Texas, 77030-4211, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    RECRUITING

    Gainesville, Florida, 32608-1135, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

  • VA NY Harbor Healthcare System, New York, NY

    RECRUITING

    New York, New York, 10010-5011, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    RECRUITING

    Dallas, Texas, 75216-7167, United States

  • VA Western New York Healthcare System, Buffalo, NY

    RECRUITING

    Buffalo, New York, 14215-1129, United States

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