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Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine 0.5 MG | Active Comparator | Colchicine 0.5 MG, one pill a day, oral intake |
|
| Colchicine 0.375 MG | Active Comparator | Colchicine 0.375 MG, one pill a day, oral intake |
|
| Colchicine 0.25 MG | Active Comparator | Colchicine 0.25 MG, one pill a day, oral intake |
|
| Placebo | Placebo Comparator | Placebo, one pill a day, oral intake |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine 0.5 MG | Drug | Colchicine 0.5 MG, one pill a day, oral intake |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in hsCRP | The percentage change in hsCRP compared to baseline | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular event (MACCE) | Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia | 4 weeks |
| Bleeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33769515 | Background | Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115. | |
| 37558377 |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Colchicine 0.375 MG |
| Drug |
Colchicine 0.375 MG, one pill a day, oral intake |
|
| Colchicine 0.25 MG | Drug | Colchicine 0.25 MG, one pill a day, oral intake |
|
| Placebo | Drug | Placebo, one pill a day, oral intake |
|
Bleeding defined according to Bleeding Academic Research Consortium
| 4 weeks |
| Plasma inflammatory cytokines level | Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc) | 4 weeks |
| Blood drug concentrations of different doses of colchicine | Blood drug concentrations of different doses of colchicine | 4 weeks |
| Expression of inflammation-related proteins in peripheral blood mononuclear cells | Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc) | 4 weeks |
| Background |
| Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |