Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With Stable Coronary Artery Disease

Korábbi kezelés

• Requirement for long term colchicine therapy for any other reason
• Patients already taking long term colchicine therapy for any other reason

Más betegség

• 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
• Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patients with chronic diarrhea
• Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study
• Patient with progressive neuromuscular disease of Creatine Phosphokinase (CPK) level >3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing.
• History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy
• Allergy to contrast material

Laborértékek

• Renal impairment as evidenced by a serum creatinine >150 μmol/l or estimated glomerular filtration rate (eGFR) <50mL/min/1.73m2

Életkor

• Dependency, frailty or a predicted life expectancy < 5 years

Egyéb

• Women who are pregnant, breast feeding or may be considering pregnancy during the study period
• Peripheral neuritis, myositis or marked myo-sensitivity to statins
• Current enrollment in another trial
• Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI.

• 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
• Patients must provide written informed consent after the scope and nature of the investigation has been explained to them.
• Patients must be able and willing to comply with the requirements of this study protocol