NCT06025071

Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Efficacy and Safety of Residual Inflammatory Risk-Guided Low-dose Colchicine Therapy in Elderly Patients With Multivessel Coronary Artery Disease: A Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2023-09-06
• Last updated: 2023-09-06

Locations

1 site across 1 country: China