Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Phase 4

Not yet recruiting

• Conditions: Elderly Patients; Percutaneous Coronary Intervention; C-Reactive Protein; Multivessel Coronary Artery Disease
• Interventions: Drug: colchicine

• Registration Number: NCT06025071
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-02
• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted QC: 2023-09-01
• Last Update Submitted: 2023-09-01
• Study First Posted: 2023-09-06
• Last Update Posted: 2023-09-06
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Aged 60-80 years old
• Baseline plasma hs-CRP≥2 mg/L
• Hospitalized patients with coronary artery disease with multi-vessel lesions (multi-vessel lesions are defined as at least 2 major epicardial coronary arteries with ≥50% stenosis in their main branch diameter confirmed by coronary CT or coronary angiography, with or without left main artery disease)
• Patients with myocardial ischemia-related symptoms or objective evidence are successfully treated with PCI, and the condition is relatively stable
• Received standard drug therapies based on their condition at baseline (including antiplatelet, lipid-lowering, blood pressure control, blood glucose control, and other treatments recommended by guidelines)
• Subjects or legal representatives have signed informed consent.

Exclusion Criteria

• Patients who have acute myocardial infarction within 30 days
• Patients who have taken colchicine and have a clear history of allergy or intolerance
• Patients with renal insufficiency, eGFR <30 ml/min/1.73 m^2 (calculated by MDRD formula) or blood creatinine levels exceeding 2 times the upper normal limit
• Patients with cirrhosis, chronic active hepatitis, liver function impairment (alanine aminotransferase exceeding 3 times the upper normal limit or total bilirubin exceeding 2 times the upper normal limit) or cholestasis
• Patients with a known history of hypomyelodysplasia
• Patients with heart failure (NYHA Class III-IV) or severe valvular disease
• Patients with concomitant neoplastic or cancer disease
• Patients with chronic obstructive pulmonary disease or other chronic pulmonary disease
• Patients with poorly controlled disease, such as current cardiogenic shock, hemodynamic instability, heart failure (NYHA Class III-IV), left ventricular ejection fraction less than 35%, recent stroke (within the past 3 months), or any other condition in which the investigator believes that participation in this study puts the patient at risk
• Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
• Patients with hemoglobin less than 115 g/L, white blood cell count less than 4.0*10^9/L, or platelet count less than 110*10^9/L
• Patients are currently using or plan to begin chronic systemic steroid therapy (oral or intravenous) during the study period (topical or inhaled steroids are allowed)
• Patients with acute inflammation or viral infection
• Female patients who are currently pregnant, planning to become pregnant, or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine group	colchicine	Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	From randomization to occurence of first event, assessed up to one year	Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death	From randomization to occurence of first event, assessed up to one year	Number of participants with cardiovascular death.
Spontaneous (nonprocedural) myocardial infarction	From randomization to occurence of first event, assessed up to one year	Number of participants with spontaneous (nonprocedural) myocardial infarction.
Ischemic stroke	From randomization to occurence of first event, assessed up to one year	Number of participants having had a ischemic stroke.
Change of white blood cell count	From randomization to treatment at one month and one year	Change of white blood cell count comparing to the baseline
Change of monocyte count	From randomization to the end of treatment at one year	Change of monocyte count comparing to the baseline
Ischemia-driven coronary revascularization	From randomization to occurence of first event, assessed up to one year	Number of participants with ischemia-driven coronary revascularization.
Change of hs-CRP	From randomization to treatment at one month and one year	Change of hs-CRP comparing to the baseline
Change of neutrophil count	From randomization to treatment at one month and one year	Change of neutrophil count comparing to the baseline

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC; 🇨🇳 Beijing, Beijing, China