Colchicine Use for Primary Prevention of Coronary Artery Disease

Phase 3

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Drug: Placebo; Drug: Colchicine

• Registration Number: NCT05175274
• Lead Sponsor: Qingdao Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-03
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-21
• Study Start: 2022-12-06
• Primary Completion: 2027-03-01
• Study Completion: 2028-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6792

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	1 placebo tablet every 24 hours for 3 years
Intervention Group	Colchicine	colchicine 0.5mg every 24 hours for 3 years

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Mengmei Li; 🇨🇳 Qingdao, Shandong, China