A Phase 4 interventional study of Colchicine and Prednisone in In-stent Restenosis, sponsored by Fu Wai Hospital, Beijing, China. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Fu Wai Hospital, Beijing, China · Phase 4, Interventional, and Treatment
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).
This is a prospective, randomized, open-label, blinded-endpoint evaluation, single-center Study. A total of 252 RISR patients are planned to be enrolled in Fuwai Hospital, China. Then those included subjects will be randomized to standard drug therapy (control group), standard drugs combined with lose-dose colchicine therapy (colchicine group) and standard drug combined with prednisone therapy (prednisone group). The primary endpoint of the current study is target lesion ISR confirmed by coronary angiography for 12 months, and the secondary endpoint is Major adverse cardiovascular events (MACE: a composite of death, non-fatal myocardial infarction, non-fatal stroke, and target vascular revascularization) and each MACE component, target lesion revascularization, or other coronary artery disease revascularization for 12 months. The safety endpoint is adverse reactions to colchicine, adverse reactions of prednisone, or discontinued medication due to adverse reactions. In summary, the present study is to provide new evidence and strategy about anti-inflammatory therapy for recurrent In-stent restenosis after coronary intervention.
Fu Wai Hospital, Beijing, China is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary)
Drug: Aspirin · Drug: P2Y12 Receptor Antagonist · Drug: Lipid-lowering drug
DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally)
Drug: Colchicine · Drug: Aspirin · Drug: P2Y12 Receptor Antagonist · Drug: Lipid-lowering drug
DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally)
Drug: Prednisone · Drug: Aspirin · Drug: P2Y12 Receptor Antagonist · Drug: Lipid-lowering drug
Add 0.5mg QD orally and start using it within 48 hours after intervention.
0.5mg/kg QD orally and the dosage was reduced at a rate of 5mg/d per month until 5-10mg/d, maintained for 1 year after PCI.
Patients who have re-implanted DES should receive aspirin for at least 1 year after intervention; Patients who have underwent DEB expansion should apply aspirin for at least 3 months after intervention.
Also known as: Acetylsalicylic Acid
Patients who have re-implanted DES should receive 1 P2Y12 receptor antagonist for at least 1 year after intervention; Patients who have underwent DEB expansion should apply the P2Y12 receptor antagonist for at least 3 months after intervention.
Formulate the lipid-lowering drug regimen with LDL-C\<1.4mmol/L as the target on the basis of moderate intensity or above statins.
target lesion ISR
target lesion ISR confirmed by coronary angiography for 12 months
Time frame: 12 months after randomization
Major Adverse Cardiovascular Events
a composite of mortality, non-fatal myocardial infarction, non-fatal stroke and target vascular revascularization
Time frame: 12 months after randomization
target lesion revascularization
incidence of revascularization due to target lesion
Time frame: 12 months after randomization
other coronary artery disease revascularization
incidence of revascularization due to other coronary artery disease
Time frame: 12 months after randomization
Plan to share: Yes — De-identified individual participant data will be securely stored and will be available only upon reasonable request and with approval from the study investigators, in accordance with BMJ Open's data-sharing policy.
Supporting information: Study protocol, Sap
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Fu Wai Hospital, Beijing, China