Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)
NCT ID: NCT04848857
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2021-05-03
2023-10-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment Group
colchicine (0.5mg), one pill a day, oral intake
Colchicine
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.
Control Group
placebo, one pill a day, oral intake
Placebo
the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.
Interventions
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Colchicine
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
the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
3. hospitalized patients diagnosed with acute coronary syndrome within 1 month.
4. 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.
5. the lesion shown by OCT was lipid-rich plaque (Lipid pool arc \> 90 °).
Exclusion Criteria
2. Colchicine was taken within 10 days before randomization.
3. Abnormal liver function (ALT \> 3 times the upper limit of normal value).
4. Abnormal renal function (creatinine clearance rate \< 45 ml/min).
5. Thrombocytopenia (PLT \< 100G/L).
6. Uncontrolled infectious diseases during the screening period.
7. Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.
8. Pre-existing or plan for the administration of systemic anti-inflammatory treatments such as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs.
9. History of surgery or interventional therapy within 6 months prior to the screening period.
10. A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.
11. Left main coronary disease (≥50% reduction in lumen diameter by angiographic visual estimation).
12. Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
13. Diagnosed with mental disorders such as anxiety or depression.
14. Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.
15. Participated in other clinical trials within 3 months before the screening period.
16. Do not receive standardized treatment after being diagnosed with coronary heart disease.
17. The life expectancy of the subjects is less than 1 year.
18. The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Xiang Cheng
professor, director
Locations
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Wuhan Union Hospital
Wuhan, Hubei, China
Countries
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References
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Yu M, Yang Y, Dong SL, Zhao C, Yang F, Yuan YF, Liao YH, He SL, Liu K, Wei F, Jia HB, Yu B, Cheng X. Effect of Colchicine on Coronary Plaque Stability in Acute Coronary Syndrome as Assessed by Optical Coherence Tomography: The COLOCT Randomized Clinical Trial. Circulation. 2024 Sep 24;150(13):981-993. doi: 10.1161/CIRCULATIONAHA.124.069808. Epub 2024 Aug 21.
Other Identifiers
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CTACS202001
Identifier Type: -
Identifier Source: org_study_id