Effect of Colchicine on Progression of Known Coronary Atherosclerosis in Patients With STable CoROnary Artery Disease CoMpared to Placebo - EKSTROM Trial

32857-01-EKSTROM

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.

2023-03-15

2024-09-07

2024-09-07

Active (not recruiting)

Early phase I

84

Inclusion Criteria: 1. Age 30-85 years 2. Proven coronary artery disease; as evidenced by coronary angiography, CT coronary angiography or a Coronary Artery Calcium Score (Agatston score \>400). 3. Clinically stable for at least six months 4. Patients should have no major competing co-morbidities or contra-indication to colchicine therapy 5. Patients must be considered to be compliant with their usual therapy 6. Willingness to be on birth control for women of childbearing age or established postmenopausal for at least 1 year 7. Patients must provide written informed consent after the scope and nature of the investigation has been explained to them. 8. Patients must be considered to be compliant with their usual therapy 9. Patients must provide written informed consent after the scope and nature of the investigation has been explained to them. 10. Patients must be able and willing to comply with the requirements of this study protocol Exclusion Criteria: 1. Women who are pregnant, breast feeding or may be considering pregnancy during the study period 2. Renal impairment as evidenced by a serum creatinine \>150 μmol/l or estimated glomerular filtration rate (eGFR) \<50mL/min/1.73m2 3. Severe heart failure - systolic or diastolic New York Heart Association Functional classification 3 or 4 4. Moderate or severe valvular heart disease considered likely to require intervention 5. Dependency, frailty or a predicted life expectancy \< 5 years 6. Peripheral neuritis, myositis or marked myo-sensitivity to statins 7. Requirement for long term colchicine therapy for any other reason 8. Current enrollment in another trial 9. Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patients with chronic diarrhea 10. 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 11. 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. 12. Patients already taking long term colchicine therapy for any other reason 13. History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy 14. Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI. 15. Allergy to contrast material

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2024-04-02