C-Reactive Protein, Elderly Patients, Multivessel Coronary Artery Disease, Percutaneous Coronary Intervention
Conditions
Keywords
multivessel coronary artery disease, percutaneous coronary intervention, elderly patients, colchicine, high sensitive-C reactive protein, efficacy and safety
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.
Interventions
DRUGcolchicine
Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
Sponsors
Chinese Academy of Medical Sciences, Fuwai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
Intervention model description
Open-label, Two-arm, Randomized, Superiority Trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | From randomization to occurence of first event, assessed up to one year | Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous (nonprocedural) myocardial infarction | From randomization to occurence of first event, assessed up to one year | Number of participants with spontaneous (nonprocedural) myocardial infarction. |
| Ischemia-driven coronary revascularization | From randomization to occurence of first event, assessed up to one year | Number of participants with ischemia-driven coronary revascularization. |
| Ischemic stroke | From randomization to occurence of first event, assessed up to one year | Number of participants having had a ischemic stroke. |
| Cardiovascular death | From randomization to occurence of first event, assessed up to one year | Number of participants with cardiovascular death. |
| Change of white blood cell count | From randomization to treatment at one month and one year | Change of white blood cell count comparing to the baseline |
| Change of neutrophil count | From randomization to treatment at one month and one year | Change of neutrophil count comparing to the baseline |
| Change of monocyte count | From randomization to the end of treatment at one year | Change of monocyte count comparing to the baseline |
| Change of hs-CRP | From randomization to treatment at one month and one year | Change of hs-CRP comparing to the baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| New tumors | From randomization to treatment at one month and one year | Treatment-related adverse events as new tumors |
| Blood pressure | From randomization to treatment at one month and one year | Both systolic and diastolic blood pressure |
| Heart rate | From randomization to treatment at one month and one year | — |
| White blood cell count | From randomization to treatment at one month and one year | — |
| Neutrophil count | From randomization to treatment at one month and one year | — |
| Monocyte count | From randomization to treatment at one month and one year | — |
| Hematocrit | From randomization to treatment at one month and one year | — |
| Hemoglobin level | From randomization to treatment at one month and one year | — |
| Platelet count | From randomization to treatment at one month and one year | — |
| Nausea | From randomization to treatment at one month and one year | Treatment-related adverse events as nausea |
| Aspartate aminotransferase | From randomization to treatment at one month and one year | — |
| Gamma-glutamyltransferase | From randomization to treatment at one month and one year | — |
| Total bilirubin | From randomization to treatment at one month and one year | — |
| Direct bilirubin | From randomization to treatment at one month and one year | — |
| Serum albumin | From randomization to treatment at one month and one year | — |
| Total serum protein | From randomization to treatment at one month and one year | — |
| Serum creatinine | From randomization to treatment at one month and one year | — |
| Blood urea nitrogen | From randomization to treatment at one month and one year | — |
| Creatine Kinase | From randomization to treatment at one month and one year | — |
| Alanine aminotransferase | From randomization to treatment at one month and one year | — |
| Vomiting | From randomization to treatment at one month and one year | Treatment-related adverse events as vomiting |
| Diarrhea | From randomization to treatment at one month and one year | Treatment-related adverse events as diarrhea |
| Abdominal pain | From randomization to treatment at one month and one year | Treatment-related adverse events as abdominal pain |
| Muscle pain | From randomization to treatment at one month and one year | Treatment-related adverse events as muscle pain |
| Neuritis | From randomization to treatment at one month and one year | Treatment-related adverse events as neuritis |
| Rash | From randomization to treatment at one month and one year | Treatment-related adverse events as rash |
| Gout | From randomization to treatment at one month and one year | Treatment-related adverse events as gout |
| Hospitalization for infections | From randomization to treatment at one month and one year | Treatment-related adverse events as hospitalization for infections |
Countries
China
Contacts
Primary ContactXueyan Zhao, M.D.
Outcome results
None listed