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This study aims to evaluate whether daily low-dose colchicine (0.5 mg), administered in addition to the standard secondary prevention regimen recommended in clinical guidelines after coronary artery bypass grafting (CABG), can further prevent graft failure after CABG through a prospective, randomized, double-blind, placebo-controlled clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine group | Experimental | Patients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus colchicine (0.5 mg qd) starting as soon as possible (within 24 hours) and continuing for 24 months. |
|
| Placebo group | Placebo Comparator | Patients are randomized within 3 days after successful isolated CABG, and on the day of randomization, eligible patients receive guideline-directed standard secondary prevention therapy plus matching placebo (1 tablet qd) starting as soon as possible (within 24 hours) and continuing for 24 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine Pill | Drug | Colchicine 0.5 mg once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| graft failure rate | At 24 months postoperatively, all patients who complete the study will undergo coronary computed tomographic angiography (CCTA) to assess graft patency, calculated as 1 minus graft failure rate, where graft failure rate = (number of grafts graded B or O according to the Fitzgibbon classification / total number of grafts) × 100%. | 2 year after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE | Major adverse cardiovascular and cerebrovascular events include cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operating-related) myocardial infarction, readmission for acute coronary syndrome, and Coronary revascularization | 2 year after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoli Liu, PhD, MD | Contact | 8613581633895 | liuxiaoli@ccmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Beijing | Beijing Municipality | 100029 | China |
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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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|
| Placebo | Drug | Placebo one tablet once daily will be given on the basis of guideline-recommended standard secondary prevention therapy after CABG for 24 months. |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |