Colchicine Use for Primary Prevention of Coronary Artery Disease

March 6, 2022 updated by: Qingdao Central Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6792

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
3 years
Occurrence of adverse events in both groups
Time Frame: 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.
3 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Collaborators

Qingdao Municipal Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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