Comparing anti-inflammatory therapies for recurrent in-stent restenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of standard drug therapy versus standard therapy combined with low-dose colchicine or prednisone in patients with recurrent in-stent restenosis (RISR) after coronary intervention. It is a prospective, randomized, open-label, blinded-endpoint evaluation conducted at Fuwai Hospital in China, aiming to enroll 252 patients. The primary endpoint is the confirmation of target lesion ISR via coronary angiography over 12 months, while secondary endpoints include major adverse cardiovascular events and safety assessments related to the therapies. The goal is to provide new evidence and strategies for managing RISR.

Why it matters

Who can join: the full rules

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

Where it's running

• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Luhe Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fuwai Hospital
  Beijing, Beijing Municipality, China Recruiting
• Beijing Friendship Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Principal investigator: Haiyan Qian — Fuwai Hospital, Beijing, China
• Study coordinator: Haiyan Qian
• Email: ahqhy712@163.com
• Phone: +8613811386143

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.