Last updated: December 12, 2023
Sponsor: Wuhan Union Hospital, China
Overall Status: Completed
Phase
4
Condition
Chest Pain
Angina
Coronary Artery Disease
Treatment
Placebo
Colchicine
Clinical Study ID
NCT04848857
CTACS202001
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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% byvisual estimation on coronary angiography (CAG) after completing any plannedpercutaneous revascularization.
- the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).
Exclusion
Exclusion Criteria:
- 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 treatmentssuch as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory andchemotherapeutic drugs.
- History of surgery or interventional therapy within 6 months prior to the screeningperiod.
- A history of coronary artery bypass grafting or a plan for coronary artery bypassgrafting within 1 year.
- Left main coronary disease (≥50% reduction in lumen diameter by angiographic visualestimation).
- 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 effectivecontraceptive methods.
- Participated in other clinical trials within 3 months before the screening period.
- Do not receive standardized treatment after being diagnosed with coronary heartdisease.
- The life expectancy of the subjects is less than 1 year.
- The researchers determined that other conditions in which the patient was not suitableto participate in the clinical trial.
Study Design
Total Participants: 128
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
May 03, 2021
Estimated Completion Date:
October 05, 2023
Study Description
Connect with a study center
Wuhan Union Hospital
Wuhan, Hubei
ChinaSite Not Available

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