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

NCT05618353 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: CARA-003-22SI01CX002358-01A2
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  Defined as a composite rate of myocardial injury, non-fatal MI, non-fatal stroke, and all-cause mortality.

  30 days post-operation

Secondary Outcomes (7)

• rate of myocardial injury

  30 days post-operation

• rate of non-fatal MI

  30 days post-operation

• rate of non-fatal stroke

  30 days post-operation

• rate of all-cause mortality

  30 days post-operation

• Unplanned coronary revascularization

  30 days post-operation

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

One day before surgery: Colchicine 1.2 mg with 0.6 mg PO one hour later. This load will be followed by colchicine 0.6 mg twice daily for a total of 14 days.

Drug: Colchicine

Placebo

PLACEBO COMPARATOR

Matching placebo at same time points as active comparator

Drug: Placebo

Interventions

Colchicine DRUG

0.6 mg tablets

Also known as: Colcrys

Colchicine

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• NYU Langone Health: collaborator

Study Sites (9)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233-1927, United States

RECRUITING

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

RECRUITING

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

Gainesville, Florida, 32608-1135, United States

RECRUITING

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, 14215-1129, United States

RECRUITING

VA NY Harbor Healthcare System, New York, NY

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

RECRUITING

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

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

Dallas, Texas, 75216-7167, United States

RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Binita Shah, MD

  VA NY Harbor Healthcare System, New York, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Yudkevich

CONTACT

(718) 836-6600; jennifer.yudkevich@va.gov

Taj Kaur

CONTACT

(212) 686-7500; tajinder.kaur@va.gov

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Matching placebo at the same time points as the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: One day before surgery: Colchicine 1.2 mg with 0.6 mg PO one hour later. This load will be followed by colchicine 0.6 mg twice daily for a total of 14 days. If a patient is unable to take oral medications (by mouth or nasogastric tube) post-operatively (e.g., post abdominal surgery), colchicine will be held until the clinically treating physician allows resumption of oral medications if still within 14 days post-operation.

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 16, 2022
• Study Start: August 21, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)