Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Percutaneous Coronary Intervention Clinical Trial

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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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06025071
• Other study ID #: 2023-GSP-GG-40
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 2023
• Est. completion date: October 2025

Study information

• Verified date: September 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Xueyan Zhao, M.D.
• Phone: 86-10-88322051
• Email: zhao_xueyan[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• C-Reactive Protein
• Coronary Artery Disease
• Coronary Disease
• Elderly Patients
• Multivessel Coronary Artery Disease
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nausea	Treatment-related adverse events as nausea	From randomization to treatment at one month and one year
Other	Vomiting	Treatment-related adverse events as vomiting	From randomization to treatment at one month and one year
Other	Diarrhea	Treatment-related adverse events as diarrhea	From randomization to treatment at one month and one year
Other	Abdominal pain	Treatment-related adverse events as abdominal pain	From randomization to treatment at one month and one year
Other	Muscle pain	Treatment-related adverse events as muscle pain	From randomization to treatment at one month and one year
Other	Neuritis	Treatment-related adverse events as neuritis	From randomization to treatment at one month and one year
Other	Rash	Treatment-related adverse events as rash	From randomization to treatment at one month and one year
Other	Gout	Treatment-related adverse events as gout	From randomization to treatment at one month and one year
Other	Hospitalization for infections	Treatment-related adverse events as hospitalization for infections	From randomization to treatment at one month and one year
Other	New tumors	Treatment-related adverse events as new tumors	From randomization to treatment at one month and one year
Other	Blood pressure	Both systolic and diastolic blood pressure	From randomization to treatment at one month and one year
Other	Heart rate		From randomization to treatment at one month and one year
Other	White blood cell count		From randomization to treatment at one month and one year
Other	Neutrophil count		From randomization to treatment at one month and one year
Other	Monocyte count		From randomization to treatment at one month and one year
Other	Hematocrit		From randomization to treatment at one month and one year
Other	Hemoglobin level		From randomization to treatment at one month and one year
Other	Platelet count		From randomization to treatment at one month and one year
Other	Alanine aminotransferase		From randomization to treatment at one month and one year
Other	Aspartate aminotransferase		From randomization to treatment at one month and one year
Other	Gamma-glutamyltransferase		From randomization to treatment at one month and one year
Other	Total bilirubin		From randomization to treatment at one month and one year
Other	Direct bilirubin		From randomization to treatment at one month and one year
Other	Serum albumin		From randomization to treatment at one month and one year
Other	Total serum protein		From randomization to treatment at one month and one year
Other	Serum creatinine		From randomization to treatment at one month and one year
Other	Blood urea nitrogen		From randomization to treatment at one month and one year
Other	Creatine Kinase		From randomization to treatment at one month and one year
Primary	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	Cardiovascular death	Number of participants with cardiovascular death.	From randomization to occurence of first event, assessed up to one year
Secondary	Spontaneous (nonprocedural) myocardial infarction	Number of participants with spontaneous (nonprocedural) myocardial infarction.	From randomization to occurence of first event, assessed up to one year
Secondary	Ischemia-driven coronary revascularization	Number of participants with ischemia-driven coronary revascularization.	From randomization to occurence of first event, assessed up to one year
Secondary	Ischemic stroke	Number of participants having had a ischemic stroke.	From randomization to occurence of first event, assessed up to one year
Secondary	Change of hs-CRP	Change of hs-CRP comparing to the baseline	From randomization to treatment at one month and one year
Secondary	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
Secondary	Change of neutrophil count	Change of neutrophil count comparing to the baseline	From randomization to treatment at one month and one year
Secondary	Change of monocyte count	Change of monocyte count comparing to the baseline	From randomization to the end of treatment at one year