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Anti-inflammatory Therapy for Recurrent In-stent Restenosis

NCT06090890 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-08-08

No results posted yet for this study

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).

Conditions

  • In-stent Restenosis

Interventions

DRUG

Colchicine

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

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.

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.

Sponsors & Collaborators

  • Fu Wai Hospital, Beijing, China

    lead OTHER

Principal Investigators

  • Haiyan Qian · Fuwai Hospital, Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2026-10-29
Completion
2027-10-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06090890 on ClinicalTrials.gov