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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | colchicine (0.5mg), one pill a day, oral intake |
|
| Control Group | Placebo Comparator | placebo, one pill a day, oral intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes of the Thickness of fibrous cap of coronary artery plaque | changes of the thickness of fibrous cap of coronary artery plaque measured by OCT | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| changes of the Average lipid arc of coronary artery plaque | changes of the average lipid arc of coronary artery plaque measured by OCT | 12 months |
| changes of the Macrophage accumulation in coronary artery plaque |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuhan Union Hospital | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39166327 | Derived | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine. |
|
changes of the macrophage accumulation in coronary artery plaque measured by OCT
| 12 months |
| changes of the Incidence of thin-cap fibroatheroma (TCFA) | changes of the incidence of TCFA measured by OCT | 12 months |
| changes of the Minimum lumen area (MLA) | changes of the MLA measured by OCT | 12 months |
| changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO) | changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO) | 12 months |
| major adverse cardiovascular and cerebrovascular events (MACCEs) | A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization due to ischemia | 12 months |