- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04848857
Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT) (COLOCT)
December 12, 2023 updated by: Xiang Cheng, Wuhan Union Hospital, China
The Efficacy and Safety of Colchicine in Improving the Stability of Coronary Plaque in Patients With Acute Coronary Syndrome
Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction.
We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine.
Optical coherence tomography (OCT) is the most precise method to detect plaque stability in clinical practice.
Thus, the purpose of this study is to evaluate the efficacy and safety of colchicine on improving the stability of coronary plaque in patients with acute coronary syndrome.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a single-center, randomized, double-blind, placebo-controlled clinical trial.
OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert readers.
Study Type
Interventional
Enrollment (Actual)
128
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China
- Wuhan Union Hospital
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants who understand and sign the informed consent form voluntarily.
- Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
- hospitalized patients diagnosed with acute coronary syndrome within 1 month.
- at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% by visual estimation on coronary angiography (CAG) after completing any planned percutaneous revascularization.
- the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).
Exclusion Criteria:
- Allergic to colchicine.
- Colchicine was taken within 10 days before randomization.
- Abnormal liver function (ALT > 3 times the upper limit of normal value).
- Abnormal renal function (creatinine clearance rate < 45 ml/min).
- Thrombocytopenia (PLT < 100G/L).
- Uncontrolled infectious diseases during the screening period.
- Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.
- Pre-existing or plan for the administration of systemic anti-inflammatory treatments such as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs.
- History of surgery or interventional therapy within 6 months prior to the screening period.
- A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.
- Left main coronary disease (≥50% reduction in lumen diameter by angiographic visual estimation).
- Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
- Diagnosed with mental disorders such as anxiety or depression.
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.
- Participated in other clinical trials within 3 months before the screening period.
- Do not receive standardized treatment after being diagnosed with coronary heart disease.
- The life expectancy of the subjects is less than 1 year.
- The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
colchicine (0.5mg), one pill a day, oral intake
|
colchicine is a potent anti-inflammatory drug which is currently recommended for the treatment of pericarditis and acute gout attacks, but also familial Mediterranean fever and Behçet disease.
This drug acts on inflammation through inhibition of microtubule polymerization by binding free tubule dimers.
Colchicine blunts monocyte and neutrophil invasion at the site of inflammation and reduces intracellular trafficking and thus the release of cytokine and production of reactive oxygen species and a variety of proteolytic enzymes.
|
Placebo Comparator: Control Group
placebo, one pill a day, oral intake
|
the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of the Thickness of fibrous cap of coronary artery plaque
Time Frame: 12 months
|
changes of the thickness of fibrous cap of coronary artery plaque measured by OCT
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
changes of the Average lipid arc of coronary artery plaque
Time Frame: 12 months
|
changes of the average lipid arc of coronary artery plaque measured by OCT
|
12 months
|
changes of the Macrophage accumulation in coronary artery plaque
Time Frame: 12 months
|
changes of the macrophage accumulation in coronary artery plaque measured by OCT
|
12 months
|
changes of the Incidence of thin-cap fibroatheroma (TCFA)
Time Frame: 12 months
|
changes of the incidence of TCFA measured by OCT
|
12 months
|
changes of the Minimum lumen area (MLA)
Time Frame: 12 months
|
changes of the MLA measured by OCT
|
12 months
|
changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO)
Time Frame: 12 months
|
changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO)
|
12 months
|
major adverse cardiovascular and cerebrovascular events (MACCEs)
Time Frame: 12 months
|
A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization due to ischemia
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
May 3, 2021
Primary Completion (Actual)
August 20, 2023
Study Completion (Actual)
October 5, 2023
Study Registration Dates
First Submitted
April 14, 2021
First Submitted That Met QC Criteria
April 16, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 12, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Disease
- Syndrome
- Acute Coronary Syndrome
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Gout Suppressants
- Colchicine
Other Study ID Numbers
- CTACS202001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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