Comparing anti-inflammatory therapies for recurrent in-stent restenosis
Safety and Efficacy of Low Dose Colchicine or Prednisone Combining With Standard Drug in Patients With Recurrent In-stent Restenosis: a Prospective, Randomized, Open-label Trial
This study is testing whether adding low-dose colchicine or prednisone to standard drug therapy can help people with recurrent in-stent restenosis feel better and avoid heart problems after coronary treatment.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fu Wai Hospital, Beijing, China Academic / other |
| Drugs / interventions | prednisone |
| Locations | 4 sites (Beijing, Beijing Municipality and 3 other locations) |
| Trial ID | NCT06090890 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with coronary artery disease and recurrent in-stent restenosis requiring intervention.
Not a fit: Patients with known vascular inflammatory diseases or those who have had unclear previous interventional treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from recurrent in-stent restenosis.
How similar studies have performed: Other studies have explored anti-inflammatory therapies in cardiovascular conditions, but this specific approach is novel in the context of recurrent in-stent restenosis.
Eligibility criteria
Show full inclusion / exclusion 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. 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 this trial is running
Beijing, Beijing Municipality and 3 other locations
- Beijing Anzhen Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Friendship Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
- Beijing Luhe Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Haiyan Qian — Fuwai Hospital, Beijing, China
- Study coordinator: Haiyan Qian
- Email: ahqhy712@163.com
- Phone: +8613811386143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.