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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Percutaneous Coronary Intervention; Elderly Patients; Multivessel Coronary Artery Disease; C-Reactive Protein
• Intervention / Treatment: Drug: colchicine

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xueyan Zhao, M.D.; Phone Number: 86-10-88322051; Email: zhao_xueyan@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
      • Contact: Xueyan Zhao, M.D.; Phone Number: 86-10-88322051; Email: zhao_xueyan@sina.com
      • Principal Investigator: Xueyan Zhao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: Colchicine group; Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.	Drug: colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	Treatment-related adverse events as nausea	From randomization to treatment at one month and one year
Vomiting	Treatment-related adverse events as vomiting	From randomization to treatment at one month and one year
Diarrhea	Treatment-related adverse events as diarrhea	From randomization to treatment at one month and one year
Abdominal pain	Treatment-related adverse events as abdominal pain	From randomization to treatment at one month and one year
Muscle pain	Treatment-related adverse events as muscle pain	From randomization to treatment at one month and one year
Neuritis	Treatment-related adverse events as neuritis	From randomization to treatment at one month and one year
Rash	Treatment-related adverse events as rash	From randomization to treatment at one month and one year
Gout	Treatment-related adverse events as gout	From randomization to treatment at one month and one year
Hospitalization for infections	Treatment-related adverse events as hospitalization for infections	From randomization to treatment at one month and one year
New tumors	Treatment-related adverse events as new tumors	From randomization to treatment at one month and one year
Blood pressure	Both systolic and diastolic blood pressure	From randomization to treatment at one month and one year
Heart rate		From randomization to treatment at one month and one year
White blood cell count		From randomization to treatment at one month and one year
Neutrophil count		From randomization to treatment at one month and one year
Monocyte count		From randomization to treatment at one month and one year
Hematocrit		From randomization to treatment at one month and one year
Hemoglobin level		From randomization to treatment at one month and one year
Platelet count		From randomization to treatment at one month and one year
Alanine aminotransferase		From randomization to treatment at one month and one year
Aspartate aminotransferase		From randomization to treatment at one month and one year
Gamma-glutamyltransferase		From randomization to treatment at one month and one year
Total bilirubin		From randomization to treatment at one month and one year
Direct bilirubin		From randomization to treatment at one month and one year
Serum albumin		From randomization to treatment at one month and one year
Total serum protein		From randomization to treatment at one month and one year
Serum creatinine		From randomization to treatment at one month and one year
Blood urea nitrogen		From randomization to treatment at one month and one year
Creatine Kinase		From randomization to treatment at one month and one year

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Investigators: Principal Investigator: Xueyan Zhao, M.D., Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 2, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Estimated): September 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 1, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; efficacy and safety; colchicine; elderly patients; multivessel coronary artery disease; high sensitive-C reactive protein
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: 2023-GSP-GG-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No