Efficacy of low dose colchicine on left ventricular hypertrophy in coronary artery disease patients: A randomized controlled trial

Phase 3

• Conditions: Coronary artery disease,Left ventricular hypertrophy; Coronary artery disease patients with left ventricular hypertrophy.

• Registration Number: TCTR20210721003
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-21
• Study Completion: 2023-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 122

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eft ventricular mass index 48 weeks after randomization Cardiac MRI

Secondary Outcome Measures

Name	Time	Method
eft 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