Anti-inflammatory Therapy for Recurrent In-stent Restenosis
Recruiting
Phase 4Interventional Study
In-stent Restenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
252 (estimated)
Sponsor
Fu Wai Hospital, Beijing, China · Other
Who this trial is looking for
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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 Locations
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Status
Eligibility Criteria
Inclusion Criteria:
1. CAD patients over 18 years old;
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.…
Inclusion Criteria:
1. CAD patients over 18 years old;
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:
1. The previous interventional treatment situation is unknown;
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
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