Colchicine Use for Primary Prevention of Coronary Artery Disease

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Placebo; Drug: Colchicine

• Study Type: Interventional
• Enrollment (Anticipated): 6792
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mengmei Li, MD; Phone Number: 0086053284961672; Email: sjogen@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266042
      • Mengmei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qingdao Central Hospital
• Collaborators: Qingdao Municipal Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 6, 2022
• Primary Completion (Anticipated): March 1, 2027
• Study Completion (Anticipated): July 1, 2028

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Coronary artery disease; adverse events; primary prevention
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: Col-CH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No