Anti-inflammatory therapy for recurrent in-stent restenosis (AI-ISR): study protocol for a prospective, randomised, open-label, multicentre clinical trial.
Miao Yu, Yu Jiang, Zhifeng Song...
https://pubmed.ncbi.nlm.nih.gov/41145262Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06090890
Safety and Efficacy of Low Dose Colchicine or Prednisone Combined With Standard Drugs in Patients With Recurrent In-stent Restenosis: A Prospective, Randomized, Open-label Trial
Led by Fu Wai Hospital, Beijing, China · Updated on 2025-08-08
252
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of different anti-inflammatory treatments in patients with coronary heart disease who have recurrent in-stent restenosis (RISR), a condition where arteries narrow again after stent placement. This prospective, randomized, open-label trial compares standard drug therapy alone to standard therapy combined with low-dose colchicine or prednisone. The study aims to provide new strategies for managing RISR and is conducted at a single center in China with 252 planned participants. Participants are randomly assigned to one of three groups: standard drug therapy including dual antiplatelet therapy (aspirin plus a P2Y12 receptor antagonist), lipid-lowering drugs, and other necessary medications; standard drugs plus low-dose colchicine (0.5 mg daily); or standard drugs plus prednisone starting at 0.5 mg/kg daily with a gradual dose reduction over one year. Treatments are oral and follow the specific dosing schedules, with colchicine started within 48 hours after intervention. Prednisone dosage is tapered monthly and maintained for one year after percutaneous coronary intervention (PCI). During the 12-month study period, participants will be monitored for target lesion in-stent restenosis using coronary angiography, with major adverse cardiovascular events (MACE) such as death, heart attack, stroke, and revascularization also tracked. Safety is assessed by recording adverse reactions to colchicine and prednisone, including medication discontinuation due to side effects. Follow-up includes clinical evaluation and adherence monitoring to understand the impact of these therapies on RISR management. The total participation duration is one year post-randomization.
CONDITIONS
Brief Title
Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Coronary artery disease patients aged 18 years or older
- At least one coronary artery lesion with recurrent in-stent restenosis meeting criteria of 2 or more lesions with 50% or greater narrowing
- Planned treatment for recurrent in-stent restenosis lesions
- Able to receive standard secondary prevention drugs including dual antiplatelet therapy and statins
- Willing to participate in the trial and complete follow-up with signed informed consent
You will not qualify if you...
- Unknown previous interventional treatment history
- Intracavitary imaging mechanism for ISR related to operator issues such as poor stent adhesion or fracture
- Diagnosed vascular inflammatory or connective tissue diseases involving coronary arteries
- Use of immunosuppressive drugs including glucocorticoids within past 30 days
- Contraindications to prednisone or colchicine such as serious infections, active hepatitis B or C, AIDS, blood disorders, uncontrolled diabetes, severe liver or kidney damage, active peptic ulcer or gastrointestinal bleeding, severe osteoporosis, inflammatory bowel disease or chronic diarrhea
- History of malignant tumors within 3 years
- Cognitive impairment
- Unwillingness to participate or follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months after randomization
Participants receive randomized treatment with standard drug therapy alone or combined with low dose colchicine or prednisone, alongside other standard secondary prevention drugs after coronary intervention.
Regular visits as per clinical care and monitoring
Follow-up
Duration - Up to 12 months after treatment
Participants are monitored for efficacy and safety outcomes including major adverse cardiovascular events and adverse reactions to the study drugs for up to 12 months after treatment initiation.
Periodic visits during the 12-month follow-up period
Trial Site Locations
Total: 4 locations
1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 10000
Actively Recruiting
2
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 10000
Not Yet Recruiting
3
Beijing Luhe Hospital
Beijing, Beijing Municipality, China, 10000
Actively Recruiting
4
Fuwai Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
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Research Team
H
Haiyan Qian
Z
Zhiyao Wei
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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