Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Sponsor

Fu Wai Hospital, Beijing, China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06090890

Collaborator

(none)

252

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
In-stent Restenosis	Drug: Colchicine Drug: Prednisone Drug: Aspirin Drug: P2Y12 Receptor Antagonist Drug: Lipid-lowering drug	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 30, 2023

Anticipated Primary Completion Date :

Oct 29, 2024

Anticipated Study Completion Date :

Oct 29, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control group DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary)	Drug: Aspirin 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. Other Names: Acetylsalicylic Acid Drug: P2Y12 Receptor Antagonist 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. Drug: Lipid-lowering drug Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.
Experimental: Colchicine group DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally)	Drug: Colchicine Add 0.5mg QD orally and start using it within 48 hours after intervention. Drug: Aspirin 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. Other Names: Acetylsalicylic Acid Drug: P2Y12 Receptor Antagonist 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. Drug: Lipid-lowering drug Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.
Experimental: Prednisone group DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally)	Drug: Prednisone 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. Drug: Aspirin 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. Other Names: Acetylsalicylic Acid Drug: P2Y12 Receptor Antagonist 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. Drug: Lipid-lowering drug Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.

Arm

Intervention/Treatment

Active Comparator: control group

DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary)

Drug: Aspirin

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.

Other Names:

Acetylsalicylic Acid

Drug: P2Y12 Receptor Antagonist

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.

Drug: Lipid-lowering drug

Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.

Experimental: Colchicine group

DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Colchicine (0.5mg QD, orally)

Drug: Colchicine

Add 0.5mg QD orally and start using it within 48 hours after intervention.

Drug: Aspirin

Other Names:

Acetylsalicylic Acid

Drug: P2Y12 Receptor Antagonist

Drug: Lipid-lowering drug

Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.

Experimental: Prednisone group

DAPT (aspirin+1 P2Y12 receptor antagonist) + Lipid-lowering drugs + hypoglycemic drugs and hypotensive drugs (if necessary) + Prednisone (0.5mg/kg QD, orally)

Drug: Prednisone

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.

Drug: Aspirin

Other Names:

Acetylsalicylic Acid

Drug: P2Y12 Receptor Antagonist

Drug: Lipid-lowering drug

Formulate the lipid-lowering drug regimen with LDL-C<1.4mmol/L as the target on the basis of moderate intensity or above statins.

Outcome Measures

Primary Outcome Measures

target lesion ISR [12 months after randomization]
target lesion ISR confirmed by coronary angiography for 12 months

Secondary Outcome Measures

Major Adverse Cardiovascular Events [12 months after randomization]
a composite of mortality, non-fatal myocardial infarction, non-fatal stroke and target vascular revascularization
target lesion revascularization [12 months after randomization]
target lesion revascularization
other coronary artery disease revascularization [12 months after randomization]
other coronary artery disease revascularization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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