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The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no specific intervention in selected elderly patients (60-80 years old) with residual inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions it aims to answer are:
Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no specific intervention for one year. Patients enrolled should complete one-year follow-up in the form of clinic visit or telephone call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed. |
|
| Control group | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colchicine | Drug | Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke | From randomization to occurence of first event, assessed up to one year |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | Number of participants with cardiovascular death. | From randomization to occurence of first event, assessed up to one year |
| Spontaneous (nonprocedural) myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea | Treatment-related adverse events as nausea | From randomization to treatment at one month and one year |
| Vomiting | Treatment-related adverse events as vomiting |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueyan Zhao, M.D. | Contact | 86-10-88322051 | zhao_xueyan@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Xueyan Zhao, M.D. | Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC | Beijing | Beijing Municipality | 100037 | China |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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Open-label, Two-arm, Randomized, Superiority Trial
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This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
Number of participants with spontaneous (nonprocedural) myocardial infarction.
| From randomization to occurence of first event, assessed up to one year |
| Ischemia-driven coronary revascularization | Number of participants with ischemia-driven coronary revascularization. | From randomization to occurence of first event, assessed up to one year |
| Ischemic stroke | Number of participants having had a ischemic stroke. | From randomization to occurence of first event, assessed up to one year |
| Change of hs-CRP | Change of hs-CRP comparing to the baseline | From randomization to treatment at one month and one year |
| Change of white blood cell count | Change of white blood cell count comparing to the baseline | From randomization to treatment at one month and one year |
| Change of neutrophil count | Change of neutrophil count comparing to the baseline | From randomization to treatment at one month and one year |
| Change of monocyte count | Change of monocyte count comparing to the baseline | From randomization to the end of treatment at one year |
| From randomization to treatment at one month and one year |
| Diarrhea | Treatment-related adverse events as diarrhea | From randomization to treatment at one month and one year |
| Abdominal pain | Treatment-related adverse events as abdominal pain | From randomization to treatment at one month and one year |
| Muscle pain | Treatment-related adverse events as muscle pain | From randomization to treatment at one month and one year |
| Neuritis | Treatment-related adverse events as neuritis | From randomization to treatment at one month and one year |
| Rash | Treatment-related adverse events as rash | From randomization to treatment at one month and one year |
| Gout | Treatment-related adverse events as gout | From randomization to treatment at one month and one year |
| Hospitalization for infections | Treatment-related adverse events as hospitalization for infections | From randomization to treatment at one month and one year |
| New tumors | Treatment-related adverse events as new tumors | From randomization to treatment at one month and one year |
| Blood pressure | Both systolic and diastolic blood pressure | From randomization to treatment at one month and one year |
| Heart rate | From randomization to treatment at one month and one year |
| White blood cell count | From randomization to treatment at one month and one year |
| Neutrophil count | From randomization to treatment at one month and one year |
| Monocyte count | From randomization to treatment at one month and one year |
| Hematocrit | From randomization to treatment at one month and one year |
| Hemoglobin level | From randomization to treatment at one month and one year |
| Platelet count | From randomization to treatment at one month and one year |
| Alanine aminotransferase | From randomization to treatment at one month and one year |
| Aspartate aminotransferase | From randomization to treatment at one month and one year |
| Gamma-glutamyltransferase | From randomization to treatment at one month and one year |
| Total bilirubin | From randomization to treatment at one month and one year |
| Direct bilirubin | From randomization to treatment at one month and one year |
| Serum albumin | From randomization to treatment at one month and one year |
| Total serum protein | From randomization to treatment at one month and one year |
| Serum creatinine | From randomization to treatment at one month and one year |
| Blood urea nitrogen | From randomization to treatment at one month and one year |
| Creatine Kinase | From randomization to treatment at one month and one year |