RECRUITING

The Peri-OPerative COlchicine to Reduce Negative Events (POPCORN) Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Heart disease remains the leading cause of death in Veterans. Inflammation in the arteries of the heart may increase the risk of cardiac death. Patients with heart disease undergoing major surgery are at increased risk of complications after surgery, including heart attack, stroke, and death. The proposed research seeks to better understand the role of inflammation in the damage to the heart and blood vessels after major surgery. This research also seeks to identify the potential beneficial role of a safe medication, colchicine, which has direct effects on inflammatory cells and has been used in the treatment of inflammatory diseases for more than 2000 years, on reducing the rate of complications after surgery. With its quick onset of action and excellent safety profile, colchicine may have the potential to reduce risk of heart injury, stroke, or death after major surgery.

Official Title

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

Quick Facts

Study Start:2023-08-21
Study Completion:2029-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05618353

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Referred for intermediate- or high-risk surgery (general abdominal or intraperitoneal surgery, neurosurgery, suprainguinal surgery, peripheral vascular surgery, thoracic surgery).
  3. * 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.
  1. * Colchicine use within one month or history of colchicine intolerance
  2. * Inflammatory bowel disease with history of diarrhea as presentation or chronic diarrhea
  3. * Pre-existent progressive neuromuscular disease
  4. * amyotrophic lateral sclerosis
  5. * hereditary muscular disorders
  6. * myositis
  7. * necrotizing myopathy
  8. * myasthenia gravis
  9. * lambert-eaton syndrome
  10. * Glomerular filtration rate \<30mL/minute or on dialysis
  11. * History of cirrhosis, chronic active hepatitis or severe hepatic disease
  12. * History of myelodysplasia with current evidence of cytopenia
  13. * 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)
  14. * Undergoing immunosuppressive or immunostimulatory chemo or biologic therapy
  15. * Pregnant (as confirmed by urine or serum test), nursing, or planning to become pregnant during study participation
  16. * Participating in a competing study or unable to consent
  17. * Any significant condition or situation that may put the participant at higher risk, confound the study results, or interfere with adherence to study procedures
  18. * 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
  19. * However, if one of these medications are started during the post-operative study period, dose adjustments will be made per drug package insert
  20. * Participants will also be instructed not to drink grapefruit juice while on study drug

Contacts and Locations

Study Contact

Jennifer Yudkevich
CONTACT
(718) 836-6600
jennifer.yudkevich@va.gov
Taj Kaur
CONTACT
(212) 686-7500
tajinder.kaur@va.gov

Principal Investigator

Binita Shah, MD
PRINCIPAL_INVESTIGATOR
VA NY Harbor Healthcare System, New York, NY

Study Locations (Sites)

Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233-1927
United States
VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
United States
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, 75216-7167
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Binita Shah, MD, PRINCIPAL_INVESTIGATOR, VA NY Harbor Healthcare System, New York, NY

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-21
Study Completion Date2029-04-30

Study Record Updates

Study Start Date2023-08-21
Study Completion Date2029-04-30

Terms related to this study

Keywords Provided by Researchers

  • Coronary artery disease
  • Non-cardiac surgery
  • Colchicine
  • Inflammation
  • Major adverse cardiovascular events

Additional Relevant MeSH Terms

  • Coronary Artery Disease