Overview

Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Status:
Not yet recruiting

Trial end date:
2026-10-29

Target enrollment:
0

Participant gender:
All

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 standard drug combined with prednisone therapy (prednisone group) in patients with coronary heart disease who suffered from recurrent In-stent restenosis (RISR).

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Fu Wai Hospital, Beijing, China

Treatments:

Aspirin
Colchicine
Hypolipidemic Agents
Prednisone
Purinergic P2Y Receptor Antagonists

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