💬In plain words
What the trial is, and whether it could suit you
This trial is designed to evaluate whether low-dose colchicine, in addition to standard treatment recommended by guidelines, further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Age ≥ 18 years;
* Definite diagnosis of ACS;
* Ability and willingness to provide written informed consent
Exclusion Criteria:
* Type 2 myocardial infarction (Patients with symptoms or signs of myocardial ischemia and evidence of increased oxygen demand or decreased supply \[for example, tachyarrhythmia, hypotension, or anaemia\] secondary to an alternative pathology and myocardial necrosis are defined as suffering type 2 myocardial infarction. The classification of type 2 myocardial infarction also includes patients with coronary vasospasm, embolism or spontaneous dissection without evidence of atherothrombosis related to coronary artery disease);
* Valvular heart disease that is considered likely to require surgical intervention;
* History of non-skin cancer in the past 3 years;
* Inflammatory bowel disease or chronic diarrhea;
* History of gastric ulcer or previous gastric bleeding;
* Neuromuscular diseases or non-transient (At least 2 laboratory tests) creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);
* Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities(Hemoglobin \<100g/L or hematocrit \< 30% or \> 52% or white blood cell count \< 3×109/L or platelet count \< 100×109/L);
* Estimated glomerular filtration rate (eGFR)\<30mL/min/1.73m2 (based on CKD-EPI formula);
* Serum alanine aminotransferase and/or aspartate aminotransferase levels greater than 2 times the upper limit of the normal range accompanied by serum total bilirubin levels greater than 2 times the upper limit of the normal range or severe liver disease with coagulation disorders(INR\>1.5)(except for elevated glutamic oxalacetic transaminase associated with myocardial infarction);
* Decline in cognitive function due to inability to perform basic activities of daily living independently;
* Drug or alcohol abuse;
* Other immunosuppressive therapies already in existence or planned;
* Other causes require long-term colchicine treatment;
* History of clear or suspected colchicine allergy;
* Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.
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