Colchicine Use for Primary Prevention of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05175274
• Other study ID #: Col-CH
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 6, 2022
• Est. completion date: July 1, 2028

Study information

• Verified date: March 2022
• Source: Qingdao Central Hospital
• Contact: Mengmei Li, MD
• Phone: 0086053284961672
• Email: Sjogen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6792
• Est. completion date: July 1, 2028
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Colchicine
Colchicine 0.5mg/tablet
• Placebo
matching placebo

Locations

Country	Name	City	State
China	Mengmei Li	Qingdao	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Qingdao Central Hospital	Qingdao Municipal Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	MACE events	To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes during the follow-up time.	3 years