Percutaneous Coronary Intervention Clinical Trial
— RIGHTOfficial 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
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-CRPâ„ 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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences, Fuwai Hospital |
China,
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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