Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Recruiting now · Phase 4
Conditions studied: In-stent Restenosis
In brief
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).
Key facts
- Study ID
- NCT06090890
- Run by
- Fu Wai Hospital, Beijing, China
- People needed
- 252
- Starts
- 2023-10-30
- Expected to finish
- 2027-10-29
- Last updated by the study team
- 2025-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
- Beijing Luhe Hospital — Beijing, Beijing Municipality, China (enrolling)
- Fuwai Hospital — Beijing, Beijing Municipality, China (enrolling)
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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