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The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG.
The main questions it aims to answer is:
Researchers will compare colchicine to none to see if colchicine works.
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Oral Colchicine 0.5mg qd for 1 year |
|
| Blank control | No Intervention | No Oral Colchicine therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Oral Colchicine 0.5mg qd for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Graft Failure Rate at 1 year | A protocol-driven CCTA will be used to evaluate the graft outcome at 1 year after CABG. Fitzgibbon Grade B/S/O is definned as graft failure. | at 1 year post-CABG |
| Measure | Description | Time Frame |
|---|---|---|
| The time to first 5-point Major Adverse Cardiovascular Event (MACE-5) | MACE-5 is a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and rehospitalization due to unstable angina. | within 1 year post-CABG |
| The rate of new perioperative atrial fibrillationat (PAF) within 1 week after CABG |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunpeng Zhu, MD | Contact | 02164370045 | zyp12220@rjh.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Qiang Zhao, MD | Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China | Study Chair |
| Yunpeng Zhu, MD | Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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PAF will be detected through continuous electrocardiographic monitoring. |
| within 7 days post-CABG |