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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
Alabama
Birmingham VA Medical Center, Birmingham, AL
RECRUITING
Birmingham
California
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
North Carolina
Durham VA Medical Center, Durham, NC
RECRUITING
Durham
New York
VA NY Harbor Healthcare System, New York, NY
RECRUITING
New York
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
RECRUITING
Dallas
Contact Information
Primary
Jennifer Yudkevich
jennifer.yudkevich@va.gov
(718) 836-6600
Backup
Taj Kaur
tajinder.kaur@va.gov
(212) 686-7500
Time Frame
Start Date: 2023-08-21
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 700
Treatments
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
Sponsors
Collaborators: NYU School of Medicine
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov