Status:
RECRUITING
Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Lead Sponsor:
Fu Wai Hospital, Beijing, China
Conditions:
In-stent Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 standar...
Detailed Description
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. A total of 252 RISR patients are planned to be enrolled in Fuwai Hospital, China. Then those included s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06090890
Start Date
October 30 2023
End Date
October 29 2027
Last Update
August 8 2025
Active Locations (4)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 10000
2
Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 10000
3
Beijing Luhe Hospital
Beijing, Beijing Municipality, China, 10000
4
Fuwai Hospital
Beijing, Beijing Municipality, China