RIGHT: Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06025071

Collaborator

(none)

800

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Coronary Intervention Multivessel Coronary Artery Disease Elderly Patients C-Reactive Protein	Drug: colchicine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

800 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open-label, Two-arm, Randomized, Superiority TrialOpen-label, Two-arm, Randomized, Superiority Trial

Masking:

Single (Outcomes Assessor)

Masking Description:

This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control group No intervention

Arm

Intervention/Treatment

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.

No Intervention: Control group

No intervention

Outcome Measures

Primary Outcome Measures

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

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.
Ischemia-driven coronary revascularization [From randomization to occurence of first event, assessed up to one year]
Number of participants with ischemia-driven coronary revascularization.
Ischemic stroke [From randomization to occurence of first event, assessed up to one year]
Number of participants having had a ischemic stroke.
Change of hs-CRP [From randomization to treatment at one month and one year]
Change of hs-CRP comparing to the baseline
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 neutrophil count [From randomization to treatment at one month and one year]
Change of neutrophil 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

Other Outcome Measures

Nausea [From randomization to treatment at one month and one year]
Treatment-related adverse events as nausea
Vomiting [From randomization to treatment at one month and one year]
Treatment-related adverse events as vomiting
Diarrhea [From randomization to treatment at one month and one year]
Treatment-related adverse events as diarrhea
Abdominal pain [From randomization to treatment at one month and one year]
Treatment-related adverse events as abdominal pain
Muscle pain [From randomization to treatment at one month and one year]
Treatment-related adverse events as muscle pain
Neuritis [From randomization to treatment at one month and one year]
Treatment-related adverse events as neuritis
Rash [From randomization to treatment at one month and one year]
Treatment-related adverse events as rash
Gout [From randomization to treatment at one month and one year]
Treatment-related adverse events as gout
Hospitalization for infections [From randomization to treatment at one month and one year]
Treatment-related adverse events as hospitalization for infections
New tumors [From randomization to treatment at one month and one year]
Treatment-related adverse events as new tumors
Blood pressure [From randomization to treatment at one month and one year]
Both systolic and diastolic blood pressure
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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 4.010^9/L, or platelet count less than 11010^9/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