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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT05618353
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Colchicine — DRUG
    0.6 mg tablets
  • Placebo — DRUG
    Matching placebo

Study Details

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.

Key Dates

Start date
Aug 21, 2023
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
700 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Colchicine
    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.
  • Placebo Comparator: Placebo
    Matching placebo at same time points as active comparator

Primary Outcome Measure

Major adverse cardiovascular events [ Time Frame: 30 days post-operation ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Fadi Hage, MD
[email protected]
Patti Smith
[email protected]
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Arnold Seto, MD
[email protected]
Christine Ma
[email protected]
North Florida/South Georgia Veterans Health System, Gainesville, FLGainesvilleFlorida32608-1135
Scott Berceli, MD
[email protected]
Joanne Angle
[email protected]
VA Western New York Healthcare System, Buffalo, NYBuffaloNew York14215-1129
Mariel Rivero
[email protected]
Ann Galla
[email protected]
VA NY Harbor Healthcare System, New York, NYNew YorkNew York10010-5011
Jennifer Yudkevich
[email protected]
718-836-6600
Taj Kaur
[email protected]
(212) 686-7500
Binita Shah, MD (PRINCIPAL_INVESTIGATOR)
Durham VA Medical Center, Durham, NCDurhamNorth Carolina27705-3875
Rajesh Swaminathan, MD
[email protected]
Kathy Aristy
[email protected]
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
David Zidar, MD
[email protected]
Tai-Lyn Wilkerson
[email protected]
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TXDallasTexas75216-7167
Shirling Tsai, MD
[email protected]
Anthony Emerick
[email protected]
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Neal Barshes, MD
[email protected]
Ezinne Achebe
[email protected]

Find similar trials in Birmingham, AL

By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, ALVA Long Beach Healthcare System, Long Beach, CA· Long Beach, CANorth Florida/South Georgia Veterans Health System, Gainesville, FL· Gainesville, FLVA Western New York Healthcare System, Buffalo, NY· Buffalo, NYVA NY Harbor Healthcare System, New York, NY· New York, NYDurham VA Medical Center, Durham, NC· Durham, NC

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