Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Cor… (NCT06342609) | Clinical Trial Compass
CompletedPhase 4
Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease
United States84 participantsStarted 2023-03-15
Plain-language summary
This is a randomized double-blind, placebo-controlled, investigator-initiated trial that compares Colchicine 0.5mg/day with placebo, among patients with stable CAD. Subjects will be educated to maintain medication compliance with other prescribed medications.
Who can participate
Age range30 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 30-85 years
✓. Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score \>400).
✓. Clinically stable for at least six months
✓. Patients should have no major competing co-morbidities or contra-indication to colchicine therapy
✓. Patients must be considered to be compliant with their usual therapy
✓. Willingness to be on birth control for women of childbearing age or established postmenopausal for at least 1 year
✓. Patients must provide written informed consent after the scope and nature of the investigation has been explained to them.
✓. Patients must be considered to be compliant with their usual therapy
Exclusion criteria
✕. Women who are pregnant, breast feeding or may be considering pregnancy during the study period
✕. Renal impairment as evidenced by a serum creatinine \>150 μmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2
✕. Severe heart failure - systolic or diastolic New York Heart Association Functional classification 3 or 4
✕. Moderate or severe valvular heart disease considered likely to require intervention
What they're measuring
1
Rate of change in low attenuation plaque volume as measured by multidetector computed tomography (MDCT) angiography
Timeframe: 12 months
Trial details
NCT IDNCT06342609
SponsorLundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center