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Colchicine Use for Primary Prevention of Coronary Artery Disease

Primary Purpose

Coronary Artery Disease

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
Qingdao Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Coronary artery disease, primary prevention, adverse events

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mengmei Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention Group

Control Group

Arm Description

colchicine 0.5mg every 24 hours for 3 years

1 placebo tablet every 24 hours for 3 years

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
December 14, 2021
Last Updated
March 6, 2022
Sponsor
Qingdao Central Hospital
Collaborators
Qingdao Municipal Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05175274
Brief Title
Colchicine Use for Primary Prevention of Coronary Artery Disease
Official Title
Colchicine Use for Primary Prevention in People at High Risk of Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 6, 2022 (Anticipated)
Primary Completion Date
March 1, 2027 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qingdao Central Hospital
Collaborators
Qingdao Municipal Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery disease, primary prevention, adverse events

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6792 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
colchicine 0.5mg every 24 hours for 3 years
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
1 placebo tablet every 24 hours for 3 years
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Colchicine 0.5mg/tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
The incidence of CAD
Description
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.
Time Frame
3 years
Title
Occurrence of adverse events in both groups
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
MACE events
Description
To assess the occurence of myocardial infarction, stroke and death from cardiovascular causes during the follow-up time.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mengmei Li, MD
Phone
0086053284961672
Email
Sjogen@163.com
Facility Information:
Facility Name
Mengmei Li
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Colchicine Use for Primary Prevention of Coronary Artery Disease

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