Colchicine Use for Primary Prevention of Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

6792 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2028-07-01

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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention Group

colchicine 0.5mg every 24 hours for 3 years

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

Colchicine 0.5mg/tablet

Control Group

1 placebo tablet every 24 hours for 3 years

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Interventions

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Colchicine

Colchicine 0.5mg/tablet

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No