Status:
COMPLETED
Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this ...
Detailed Description
This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliate...
Eligibility Criteria
Inclusion
- Participants who understand and sign the informed consent form voluntarily.
- Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
- hospitalized patients diagnosed with acute coronary syndrome within 1 month.
- at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% by visual estimation on coronary angiography (CAG) after completing any planned percutaneous revascularization.
- the lesion shown by OCT was lipid-rich plaque (Lipid pool arc \> 90 °).
Exclusion
- Allergic to colchicine.
- Colchicine was taken within 10 days before randomization.
- Abnormal liver function (ALT \> 3 times the upper limit of normal value).
- Abnormal renal function (creatinine clearance rate \< 45 ml/min).
- Thrombocytopenia (PLT \< 100G/L).
- Uncontrolled infectious diseases during the screening period.
- Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.
- Pre-existing or plan for the administration of systemic anti-inflammatory treatments such as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs.
- History of surgery or interventional therapy within 6 months prior to the screening period.
- A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.
- Left main coronary disease (≥50% reduction in lumen diameter by angiographic visual estimation).
- Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
- Diagnosed with mental disorders such as anxiety or depression.
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.
- Participated in other clinical trials within 3 months before the screening period.
- Do not receive standardized treatment after being diagnosed with coronary heart disease.
- The life expectancy of the subjects is less than 1 year.
- The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Key Trial Info
Start Date :
May 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT04848857
Start Date
May 3 2021
End Date
October 5 2023
Last Update
December 19 2023
Active Locations (1)
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1
Wuhan Union Hospital
Wuhan, Hubei, China