Colchicine Use for Primary Prevention of Coronary Artery Disease
1 other identifier
interventional
6,792
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 coronary-artery-disease
Started Dec 2022
Longer than P75 for phase_3 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 3, 2022
CompletedStudy Start
First participant enrolled
December 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
March 21, 2022
March 1, 2022
4.2 years
December 14, 2021
March 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
MACE events
3 years
Study Arms (2)
Intervention Group
EXPERIMENTALcolchicine 0.5mg every 24 hours for 3 years
Control Group
PLACEBO COMPARATOR1 placebo tablet every 24 hours for 3 years
Interventions
Eligibility Criteria
You may qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qingdao Central Hospitallead
- Qingdao Municipal Hospitalcollaborator
Study Sites (1)
Mengmei Li
Qingdao, Shandong, 266042, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2021
First Posted
January 3, 2022
Study Start
December 6, 2022
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
March 21, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share