Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06090890

Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Led by Fu Wai Hospital, Beijing, China · Updated on 2025-08-08

252

Participants Needed

4

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Anti-inflammatory Therapy for Recurrent In-stent Restenosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with coronary artery disease aged 18 years or older
  • At least one coronary artery lesion with recurrent in-stent restenosis (narrowing of 50% or more inside or near a stent, with two or more ISR occurrences)
  • Planned treatment for recurrent in-stent restenosis lesions
  • Able to accept standard secondary prevention drugs including dual antiplatelet therapy and statins
  • Willing to participate, complete follow-up, and sign informed consent approved by the ethics committee
Not Eligible

You will not qualify if you...

  • Unknown previous interventional treatment details
  • ISR caused by poor stent adhesion, incomplete dilation, or stent fracture as determined by intracavitary imaging
  • Diagnosed vascular inflammatory or connective tissue diseases involving coronary arteries (e.g., arteritis, Behcet's disease, lupus)
  • Use of immunosuppressive drugs including glucocorticoids within the past 30 days
  • Contraindications to prednisone or colchicine such as serious infections (active infection, hepatitis B or C, AIDS), blood disorders (thrombocytopenia, severe anemia, leukemia), uncontrolled diabetes, severe liver or kidney damage, active peptic ulcer or gastrointestinal bleeding, severe osteoporosis with past fractures, inflammatory bowel disease or chronic diarrhea
  • History of malignant tumors within past 3 years
  • Cognitive impairment
  • Unwillingness to participate or follow up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 10000

Actively Recruiting

2

Beijing Friendship Hospital

Beijing, Beijing Municipality, China, 10000

Not Yet Recruiting

3

Beijing Luhe Hospital

Beijing, Beijing Municipality, China, 10000

Actively Recruiting

4

Fuwai Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

H

Haiyan Qian

CONTACT

Z

Zhiyao Wei

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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