Colchicine Use for Primary Prevention of Coronary Artery Disease

Qingdao Central Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Coronary Artery Disease

Treatments: Drug: Colchicine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05175274

Col-CH

Details and patient eligibility

About

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.

Enrollment: 6,792 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,792 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

colchicine 0.5mg every 24 hours for 3 years

Treatment:

Drug: Colchicine

Control Group

Placebo Comparator group

Description:

1 placebo tablet every 24 hours for 3 years

Treatment:

Drug: Placebo