Residual Inflammatory Risk-Guided colcHicine in Elderly Trial (RIGHT)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase

Not yet enrolling

Phase 4

Conditions

Multivessel Coronary Artery Disease

Percutaneous Coronary Intervention

C-Reactive Protein

Elderly Patients

Treatments

Drug: colchicine

Study type

Interventional

Funder types

Other

Identifiers

NCT06025071

2023-GSP-GG-40

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

60 to 80 years old

Volunteers

No Healthy Volunteers

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