Coronary Atherosclerotic Heart Disease
Conditions
Interventions
Control Group:Blank control
Intervention Group:Postoperative colchicine treatment
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old; 2. Any sex; 3. Signed informed consent; 4. Within 3 days after a successful isolated CABG.
Exclusion criteria
Exclusion criteria: 1. Allergic or intolerant to colchicine: including allergies to active ingredients or excipients; Active diarrhea; 2. Combine the use of P-glycoprotein inhibitors or potent CYP3A4 inhibitors; a) P-glycoprotein inhibitors: cyclosporine, ranolazine; b) Strong CYP3A4 inhibitors: Azanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazone, nefinavir, ritonavir, saquinamivir, telicamycin, telanavir/ritonavir; 3. Due to other indications requiring the use of colchicine, such as during the acute phase of gouty arthritis; 4. Severe liver and kidney dysfunction: serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal by three times and/or glomerular filtration rate (eGFR)<30ml/(min × 1.73m ²); 5. Hematopoietic system abnormalities: leukopenia (white blood cell count<4.0 × 10 ?/L), thrombocytopenia (platelet count<100 × 10 ?/L), etc; 6. Women of childbearing age who are pregnant, breastfeeding, or not using contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Graft lesion rate at 1 year after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the first occurrence of Major Adverse Cardiovascular Events (MACE-5);Incidence of serious adverse events of special interest;within 1 year after surgery;Incidence of new-onset perioperative atrial fibrillation (POAF); | — |
Countries
China
Contacts
Public ContactQiang Zhao
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed