Clinical trial NCT06025071: Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Percutaneous Coronary Intervention
Multivessel Coronary Artery Disease
Elderly Patients
C-Reactive Protein
Keywords: multivessel coronary artery disease
percutaneous coronary intervention
elderly patients
colchicine
high sensitive-C reactive protein
efficacy and safety
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 800
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, Two-arm, Randomized, Superiority Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: From randomization to occurence of first event, assessed up to one year
Secondary outcomes:
measure: Cardiovascular death
timeFrame: From randomization to occurence of first event, assessed up to one year
measure: Spontaneous (nonprocedural) myocardial infarction
timeFrame: From randomization to occurence of first event, assessed up to one year
measure: Ischemia-driven coronary revascularization
timeFrame: From randomization to occurence of first event, assessed up to one year
measure: Ischemic stroke
timeFrame: From randomization to occurence of first event, assessed up to one year
measure: Change of hs-CRP
timeFrame: From randomization to treatment at one month and one year
measure: Change of white blood cell count
timeFrame: From randomization to treatment at one month and one year
measure: Change of neutrophil count
timeFrame: From randomization to treatment at one month and one year
measure: Change of monocyte count
timeFrame: From randomization to the end of treatment at one year
Other outcomes:
measure: Nausea
timeFrame: From randomization to treatment at one month and one year
measure: Vomiting
timeFrame: From randomization to treatment at one month and one year
measure: Diarrhea
timeFrame: From randomization to treatment at one month and one year
measure: Abdominal pain
timeFrame: From randomization to treatment at one month and one year
measure: Muscle pain
timeFrame: From randomization to treatment at one month and one year
measure: Neuritis
timeFrame: From randomization to treatment at one month and one year
measure: Rash
timeFrame: From randomization to treatment at one month and one year
measure: Gout
timeFrame: From randomization to treatment at one month and one year
measure: Hospitalization for infections
timeFrame: From randomization to treatment at one month and one year
measure: New tumors
timeFrame: From randomization to treatment at one month and one year
measure: Blood pressure
timeFrame: From randomization to treatment at one month and one year
measure: Heart rate
timeFrame: From randomization to treatment at one month and one year
measure: White blood cell count
timeFrame: From randomization to treatment at one month and one year
measure: Neutrophil count
timeFrame: From randomization to treatment at one month and one year
measure: Monocyte count
timeFrame: From randomization to treatment at one month and one year
measure: Hematocrit
timeFrame: From randomization to treatment at one month and one year
measure: Hemoglobin level
timeFrame: From randomization to treatment at one month and one year
measure: Platelet count
timeFrame: From randomization to treatment at one month and one year
measure: Alanine aminotransferase
timeFrame: From randomization to treatment at one month and one year
measure: Aspartate aminotransferase
timeFrame: From randomization to treatment at one month and one year
measure: Gamma-glutamyltransferase
timeFrame: From randomization to treatment at one month and one year
measure: Total bilirubin
timeFrame: From randomization to treatment at one month and one year
measure: Direct bilirubin
timeFrame: From randomization to treatment at one month and one year
measure: Serum albumin
timeFrame: From randomization to treatment at one month and one year
measure: Total serum protein
timeFrame: From randomization to treatment at one month and one year
measure: Serum creatinine
timeFrame: From randomization to treatment at one month and one year
measure: Blood urea nitrogen
timeFrame: From randomization to treatment at one month and one year
measure: Creatine Kinase
timeFrame: From randomization to treatment at one month and one year
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
name: Xueyan Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: