Anti-inflammatory Therapy for Recurrent In-stent Restenosis
NCT ID: NCT06090890
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
252 participants
INTERVENTIONAL
2023-10-30
2027-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control group
DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary)
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.
Colchicine group
DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally)
Colchicine
Add 0.5mg QD orally and start using it within 48 hours after intervention.
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.
Prednisone group
DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally)
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.
Interventions
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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
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Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fu Wai Hospital, Beijing, China
OTHER
Responsible Party
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Qian Haiyan
Director，Clinical Professor
Principal Investigators
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Haiyan Qian
Role: PRINCIPAL_INVESTIGATOR
Fuwai Hospital, Beijing, China
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
Beijing Luhe Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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Yu M, Jiang Y, Song Z, Wei ZY, Tan F, Liu X, Zhang X, Zhu F, Shi Y, Huang J, Yang WX, Qian HY. Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial. BMJ Open. 2025 Oct 27;15(10):e092235. doi: 10.1136/bmjopen-2024-092235.
Other Identifiers
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2023-GSP-GG-32
Identifier Type: -
Identifier Source: org_study_id
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