Colchicine Use for Primary Prevention of Coronary Artery Disease

Study Overview
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Brief Summary
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Colchicine has been widely used as an anti-gout medicine in the past decades. Some recent clinical trials have proved that low-dose colchicine can be used as a secondary prevention drug for coronary artery disease because of its anti-inflammatory mechanism. However, the effect on primary prevention has not been observed sufficiently. The objective of this study is to determine whether colchicine reduces the incidence of CAD in patients and its safety for long-term use.

Official Title
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Colchicine Use for Primary Prevention in People at High Risk of Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Colchicine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Males and females who have at least 3 risk factors for CAD. 2. GFR>90mmol/L. 3 People are within 40-70 years old.4. Patients are not pre-diagnosed with CAD, which is defined by negative results of CT coronary angiography. Exclusion Criteria: 1. Patients with any pre-existing diagnosis of coronary artery disease.2.Other cardiovascular diseases such as peripheral vascular disease, congestive heart failure and cardiomyopathy.3.Cerebrovascular diseases such as cerebral thrombosis and cerebral hemorrhage. 4.Currently on treatment with colchicine.5.Patients who are known to be allergic to colchicine.6 Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %), documented before recruitment.7.Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.8.Any other non cardiovascular diseases, such as active malignancy requiring treatment at the time of screening or with a life expectancy of fewer than two years based on the investigator´s clinical judgment.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>colchicine 0.5mg every 24 hours for 3 years | Drug: Colchicine<br>* Colchicine 0.5mg/tablet<br>|
| Placebo Comparator: Control Group<br>1 placebo tablet every 24 hours for 3 years | Drug: Placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of CAD | Collect the incidence of CAD during the follow-up time. CAD is defined with the positive stress test, ST depression in ECG with typical symptoms of myocardial ischemia, and progression to myocardial infarction. To further detect patients with occult CAD, the rest of the asymptomatic patients will be subjected to CT coronary angiography, in which CAD is defined with over 50% diameter stenosis in a major coronary artery. | 3 years | 
| Occurrence of adverse events in both groups | Collect the occurrence of adverse events in both groups during the drug use.Adverse events include gastrointestinal, liver, hematology, muscle, neurology, other sensory, infectious and death. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE events | To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes during the follow-up time. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease, primary prevention, adverse events