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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06025071
Other study ID # 2023-GSP-GG-40
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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