Status:
UNKNOWN
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
Lead Sponsor:
Chinese Academy of Medical Sciences, Fuwai Hospital
Conditions:
Percutaneous Coronary Intervention
Multivessel Coronary Artery Disease
Eligibility:
All Genders
60-80 years
Phase:
PHASE4
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-C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT06025071
Start Date
September 1 2023
End Date
October 1 2025
Last Update
September 6 2023
Active Locations (1)
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1
Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
Beijing, Beijing Municipality, China, 100037