Coronary artery disease patients with left ventricular hypertrophy. Coronary artery disease,Left ventricular hypertrophy
Conditions
Interventions
colchicine( 0.6 mg) 1 tab oral per day for 1 years, placebo ( powder tablet) 1 tab oral per day for 1 years
Active Comparator Drug,Placebo Comparator Drug
Sponsors
National Research Council of Thailand (NRCT)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants aged 18 years or over who are able to provide informed consent and are able to comply with all study protocols 2. Documented coronary artery disease with either one of the followings; 2.1 Prior history of myocardial infarction (more than 6 months ago) 2.2 Prior history of revascularization by either PCI or CABG (more than 2 months) 2.3 Presence of left ventricular hypertrophy using either echocardiography or magnetic resonance imaging (within 3 months prior to screening visit) based on echocardiographic criteria of the American Society of Echocardiography 2015; LV mass index > 115 g/m2 for men and > 95 g/m2 for women.
Exclusion criteria
Exclusion criteria: 1. History of heart failure with New York Heart Association class 3 and 4. 2. History of type 2 myocardial infarction according to the fourth universal definition of myocardial infarction. 3. Patients with hypertension whom the anti-hypertensive medications have been adjusted within 3 months prior to screening or blood pressure more than 140/90 mmHg at the screening. 4. Insulin dependent diabetes or diabetic patients whom the oral hypoglycemic drugs have been adjusted within 2 months prior to screening or randomization visit. 5. History of active cancer or history of recurrent cancer for the 5 years prior to screening. 6. History of inflammatory bowel disease including ulcerative colitis and crohns disease 7. History of chronic diarrhea 8. History of neuromuscular disease 9. History of cirrhosis or viral hepatitis or severe hepatic disease (ascites, history of gastrointestinal bleeding or hepatic encephalopathy) 10. History of Human Immunodeficiency Virus (HIV) infection 11. History of systemic fungal infection or currently on anti-fungal medications 12. History of gouty arthritis 13. Current use of colchicine for other medical conditions 14. History of colchicine allergy 15. Plan for or current use of immunosuppressive agents 16. Plan for or current use of any form of corticosteroid 17. Current use of Cytochrome P-450 CYP3A4 Inhibitors (Drug interaction) 18. Contraindication for MRI e.g. claustrophobia, pacemaker, metal implants 19. History of psychological disorders or schizophrenia 20. Hemoglobin less than 10 g/dL, white blood cell count less than 3,000 cell/mm3, platelet count less than 110,000 cell/mm3, alanine aminotransferase (ALT) more than 3 times the upper limit of normal, aspartate aminotransferase (AST) more than 3 times the upper limit of normal 21. Total bilirubin more than 2 times the upper limit of normal, serum creatinine more than 2 times the upper limit of normal within 1 months before a screening visit 22. Creatinine phosphokinase (CPK) more than 3 times the upper limit of normal within 1 months before the screening appointment or tend to rising by physicians opinion 23. eGFR-EP less than 50 ml/min at screening visit 24. Potentially to experience life threatening conditions if participate to the study 25. High chance to withdraw study participation by any conditions 26. Pregnancy or breastfeeding 27. Currently participate in other studies within 30 days before the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular mass index 48 weeks after randomization Cardiac MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular mass 48 weeks after randomization Cardiac MRI,Systolic and diastolic blood pressure 48 weeks after randomization Sphygmomanometer ,Body weight and body mass index 48 weeks after randomization Weighting scale,Fasting blood glucose 48 weeks after randomization NaF blood,Hemoglobin A1C 48 weeks after randomization EDTA blood,Fasting insulin 48 weeks after randomization EDTA blood,Insulin resistance 48 weeks after randomization fasting insulin* fasting glucose/25,Left ventricular end diastolic volume 48 weeks after randomization Cardiac MRI,Left ventricular end systolic volume 48 weeks after randomization Cardiac MRI,Left ventricular stroke volume 48 weeks after randomization Cardiac MRI,Left ventricular ejection fraction 48 weeks after randomization Cardiac MRI,Left atrial volume index 48 weeks after randomization Cardiac MRI,High-sensitivity C-reactive protein 48 weeks after randomization Lithium heparin/Clotted blood | — |
Countries
Thailand
Contacts
Public ContactPly Chichareon
Songklanagarind Hospital
Outcome results
None listed