Anti-inflammatory Therapy for Recurrent In-stent Restenosis

August 5, 2025 updated by: Qian Haiyan, Fu Wai Hospital, Beijing, China

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

252

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Fuwai Hospital
        • Contact:
      • Beijing, Beijing, China, 10000
        • Recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
      • Beijing, Beijing, China, 10000
        • Not yet recruiting
        • Beijing Friendship Hospital
        • Contact:
      • Beijing, Beijing, China, 10000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: 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.
Drug: Colchicine
Add 0.5mg QD orally and start using it within 48 hours after intervention.
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target lesion ISR
Time Frame: 12 months after randomization
target lesion ISR confirmed by coronary angiography for 12 months
12 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: 12 months after randomization
a composite of mortality, non-fatal myocardial infarction, non-fatal stroke and target vascular revascularization
12 months after randomization
target lesion revascularization
Time Frame: 12 months after randomization
incidence of revascularization due to target lesion
12 months after randomization
other coronary artery disease revascularization
Time Frame: 12 months after randomization
incidence of revascularization due to other coronary artery disease
12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fu Wai Hospital, Beijing, China

Investigators

  • Principal Investigator: Haiyan Qian, Fuwai Hospital, Beijing, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2023

Primary Completion (Estimated)

October 29, 2026

Study Completion (Estimated)

October 29, 2027

Study Registration Dates

First Submitted

October 15, 2023

First Submitted That Met QC Criteria

October 15, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-GSP-GG-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

De-identified individual participant data will be available only upon reasonable request and with approval from the study investigators, in accordance with BMJ Open's data-sharing policy.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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