Colchicine Use for Primary Prevention of Coronary Artery Disease

Sponsor

Qingdao Central Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05175274

Collaborator

Qingdao Municipal Hospital (Other)

6,792

Enrollment

Location

Arms

66.8

Anticipated Duration (Months)

101.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Colchicine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6792 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 6, 2022

Anticipated Primary Completion Date :

Mar 1, 2027

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group colchicine 0.5mg every 24 hours for 3 years	Drug: Colchicine Colchicine 0.5mg/tablet
Placebo Comparator: Control Group 1 placebo tablet every 24 hours for 3 years	Drug: Placebo matching placebo

Arm

Intervention/Treatment

Experimental: Intervention Group

colchicine 0.5mg every 24 hours for 3 years

Drug: Colchicine

Colchicine 0.5mg/tablet

Placebo Comparator: Control Group

1 placebo tablet every 24 hours for 3 years

Drug: Placebo

matching placebo

Outcome Measures

Primary Outcome Measures

The incidence of CAD [3 years]
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.
Occurrence of adverse events in both groups [3 years]
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.

Secondary Outcome Measures

MACE events [3 years]
To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes during the follow-up time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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:

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.