A Phase 4 interventional study of colchicine in Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease and Elderly Patients, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 1 site in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-06.
Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Phase 4, Interventional, and Treatment
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:
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.
Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 146 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
Drug: colchicine
No intervention
Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke
Time frame: From randomization to occurence of first event, assessed up to one year
Cardiovascular death
Number of participants with cardiovascular death.
Time frame: From randomization to occurence of first event, assessed up to one year
Spontaneous (nonprocedural) myocardial infarction
Number of participants with spontaneous (nonprocedural) myocardial infarction.
Time frame: From randomization to occurence of first event, assessed up to one year
Ischemia-driven coronary revascularization
Number of participants with ischemia-driven coronary revascularization.
Time frame: From randomization to occurence of first event, assessed up to one year
Ischemic stroke
Number of participants having had a ischemic stroke.
Time frame: From randomization to occurence of first event, assessed up to one year
Change of hs-CRP
Change of hs-CRP comparing to the baseline
Time frame: From randomization to treatment at one month and one year
Change of white blood cell count
Change of white blood cell count comparing to the baseline
Time frame: From randomization to treatment at one month and one year
Change of neutrophil count
Change of neutrophil count comparing to the baseline
Time frame: From randomization to treatment at one month and one year
Change of monocyte count
Change of monocyte count comparing to the baseline
Time frame: From randomization to the end of treatment at one year
Nausea
Treatment-related adverse events as nausea
Time frame: From randomization to treatment at one month and one year
Vomiting
Treatment-related adverse events as vomiting
Time frame: From randomization to treatment at one month and one year
Diarrhea
Treatment-related adverse events as diarrhea
Time frame: From randomization to treatment at one month and one year
Abdominal pain
Treatment-related adverse events as abdominal pain
Time frame: From randomization to treatment at one month and one year
Muscle pain
Treatment-related adverse events as muscle pain
Time frame: From randomization to treatment at one month and one year
Neuritis
Treatment-related adverse events as neuritis
Time frame: From randomization to treatment at one month and one year
Rash
Treatment-related adverse events as rash
Time frame: From randomization to treatment at one month and one year
Gout
Treatment-related adverse events as gout
Time frame: From randomization to treatment at one month and one year
Hospitalization for infections
Treatment-related adverse events as hospitalization for infections
Time frame: From randomization to treatment at one month and one year
New tumors
Treatment-related adverse events as new tumors
Time frame: From randomization to treatment at one month and one year
Blood pressure
Both systolic and diastolic blood pressure
Time frame: From randomization to treatment at one month and one year
Heart rate
Time frame: From randomization to treatment at one month and one year
White blood cell count
Time frame: From randomization to treatment at one month and one year
Neutrophil count
Time frame: From randomization to treatment at one month and one year
Monocyte count
Time frame: From randomization to treatment at one month and one year
Hematocrit
Time frame: From randomization to treatment at one month and one year
Hemoglobin level
Time frame: From randomization to treatment at one month and one year
Platelet count
Time frame: From randomization to treatment at one month and one year
Alanine aminotransferase
Time frame: From randomization to treatment at one month and one year
Aspartate aminotransferase
Time frame: From randomization to treatment at one month and one year
Gamma-glutamyltransferase
Time frame: From randomization to treatment at one month and one year
Total bilirubin
Time frame: From randomization to treatment at one month and one year
Direct bilirubin
Time frame: From randomization to treatment at one month and one year
Serum albumin
Time frame: From randomization to treatment at one month and one year
Total serum protein
Time frame: From randomization to treatment at one month and one year
Serum creatinine
Time frame: From randomization to treatment at one month and one year
Blood urea nitrogen
Time frame: From randomization to treatment at one month and one year
Creatine Kinase
Time frame: From randomization to treatment at one month and one year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Colchicine
Chinese Academy of Medical Sciences, Fuwai Hospital →