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Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

NCT06025071 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-09-06

No results posted yet for this study

Summary

The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no specific intervention in selected elderly patients (60-80 years old) with residual inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions it aims to answer are:

* Whether the intervention is effective in reducing ischemic events
* Whether the intervention is effective in reducing inflammatory biomarkers' level
* Whether the intervention is safe for elderly patients

Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no specific intervention for one year. Patients enrolled should complete one-year follow-up in the form of clinic visit or telephone call.

Conditions

  • Percutaneous Coronary Intervention
  • Multivessel Coronary Artery Disease
  • Elderly Patients
  • C-Reactive Protein

Interventions

DRUG

colchicine

Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    lead OTHER

Principal Investigators

  • Xueyan Zhao, M.D. · Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2025-09-30
Completion
2025-10-31

Countries

  • China

Study Locations

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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 NCT06025071 on ClinicalTrials.gov