Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial
1 other identifier
interventional
252
1 country
4
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2023
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedStudy Start
First participant enrolled
October 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 29, 2027
August 8, 2025
September 1, 2024
3 years
October 15, 2023
August 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
target lesion ISR
target lesion ISR confirmed by coronary angiography for 12 months
12 months after randomization
Secondary Outcomes (3)
Major Adverse Cardiovascular Events
12 months after randomization
target lesion revascularization
12 months after randomization
other coronary artery disease revascularization
12 months after randomization
Study Arms (3)
control group
ACTIVE COMPARATORDAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary)
Colchicine group
EXPERIMENTALDAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally)
Prednisone group
EXPERIMENTALDAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally)
Interventions
Add 0.5mg QD orally and start using it within 48 hours after intervention.
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.
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.
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.
Formulate the lipid-lowering drug regimen with LDL-C\<1.4mmol/L as the target on the basis of moderate intensity or above statins.
Eligibility Criteria
You may qualify if:
- CAD patients over 18 years old;
- 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%);
- Intended intervention treatment for RISR lesions;
- Acceptable for standard secondary prevention drug therapy for coronary heart disease, including dual antiplatelet therapy (DAPT) and statins;
- Willing to participate in the trial and complete follow-up, signing an informed consent form approved by the ethics committee
You may not qualify if:
- The previous interventional treatment situation is unknown;
- The mechanism of intracavitary imaging to clarify ISR is operator-related (poor stent adhesion, incomplete dilation, and stent fracture);
- Clearly diagnose vascular inflammatory diseases or connective tissue diseases (including arteritis, Behcet's disease, systemic lupus erythematosus, etc.) involving the coronary artery;
- Immunosuppressive drugs, including glucocorticoids, have been used in the past 30 days;
- 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;
- A history of malignant tumors within 3 years;
- Cognitive impairment;
- Not willing to participate or follow up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, 10000, China
Beijing Luhe Hospital
Beijing, Beijing Municipality, 10000, China
Fuwai Hospital
Beijing, Beijing Municipality, China
Related Publications (1)
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.
PMID: 41145262DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haiyan Qian
Fuwai Hospital, Beijing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director，Clinical Professor
Study Record Dates
First Submitted
October 15, 2023
First Posted
October 19, 2023
Study Start
October 30, 2023
Primary Completion (Estimated)
October 29, 2026
Study Completion (Estimated)
October 29, 2027
Last Updated
August 8, 2025
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Access Criteria
- De-identified individual participant data will be available only upon reasonable request and with approval from the study investigators, in accordance with BMJ Open's data-sharing policy.
De-identified individual participant data will be securely stored and will be available only upon reasonable request and with approval from the study investigators, in accordance with BMJ Open's data-sharing policy.