ColchicinePrednisoneAspirinP2Y12 Receptor AntagonistLipid-lowering drug
Colchicine: Add 0.5mg QD orally and start using it within 48 hours after intervention.
Prednisone: 0.5mg/kg QD orally and the dosage was reduced at a rate of 5mg/d per month until 5-10mg/d, maintained for 1 year after PCI.
Aspirin: Patients who have re-implanted DES should receive aspirin for at least 1 year after intervention; Patients who have underwent DEB expansion should apply aspirin for at least 3 months after intervention.
P2Y12 Receptor Antagonist: Patients who have re-implanted DES should receive 1 P2Y12 receptor antagonist for at least 1 year after intervention; Patients who have underwent DEB expansion should apply the P2Y12 receptor antagonist for at least 3 months after intervention.
Lipid-lowering drug: Formulate the lipid-lowering drug regimen with LDL-C\<1.4mmol/L as the target on the basis of moderate intensity or above statins.
Study summary
This study is aimed at making a comparison of the safety and efficacy of standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. CAD patients over 18 years old;
2. At least one coronary artery lesion meets the RISR criteria: target lesion ≥ 2 ISRs (stenosis of lumen diameter within the stent segment and within 5mm near and far of the stent ≥ 50%);
3. Intended intervention treatment for RISR lesions;
4. Acceptable for standard secondary prevention drug therapy for coronary heart disease, including dual antiplatelet therapy (DAPT) and statins;
5. Willing to participate in the trial and complete follow-up, signing an informed consent form approved by the ethics committee
Exclusion Criteria:
1. The previous interventional treatment situation is unknown;
2. The mechanism of intracavitary imaging to clarify ISR is operator-related (poor stent adhesion, incomplete dilation, and stent fracture);
3. Clearly diagnose vascular inflammatory diseases or connective tissue diseases (including arteritis, Behcet's disease, systemic lupus erythematosus, etc.) involving the coronary artery;
4. Immunosuppressive drugs, including glucocorticoids, have been used in the past 30 days;
5. There are contraindications to the use of prednisone or colchicine, including: serious infectious diseases, including active infection, hepatitis B, hepatitis C or AIDS patients; Hematological diseases, such as thrombocytopenia, severe anemia, leukemia, etc; Uncontrolled diabetes; Severe liver and kidney function damage; Active peptic ulcer or gastrointestinal bleeding; Severe osteoporosis (with previous pathological fractures); Inflammatory bowel disease or chronic diarrhea;
6. A history of malignant tumors within 3 years;
7. Cognitive impairment;
8. Not willing to participate or follow up
Primary outcome measure(s)
target lesion ISR — 12 months after randomization target lesion ISR confirmed by coronary angiography for 12 months
Trial sites (4)
Facility
City
Region
Status
Beijing Anzhen Hospital, Capital Medical University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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