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RECRUITING
NCT06090890
PHASE4

Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Sponsor: Fu Wai Hospital, Beijing, China

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

252

Start Date

2023-10-30

Completion Date

2027-10-29

Last Updated

2025-08-08

Healthy Volunteers

No

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.

Locations (4)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing Friendship Hospital

Beijing, Beijing Municipality, China

Beijing Luhe Hospital

Beijing, Beijing Municipality, China

Fuwai Hospital

Beijing, Beijing Municipality, China