Treatment of ACuTe Coronary Syndromes With Low-dose colchICine

Launched by BEIJING ANZHEN HOSPITAL · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at whether taking low-dose colchicine, along with the usual treatments for acute coronary syndrome (ACS), can help lower the chances of serious heart problems. ACS includes conditions like unstable angina and different types of heart attacks. The trial is currently recruiting participants aged 18 and older who have been diagnosed with ACS and are willing to give their consent to join the study.

If you decide to participate, you will be randomly assigned to either receive colchicine or a placebo (a harmless pill that looks the same but has no active ingredients). Throughout the trial, you will be monitored for any changes in your health and any serious heart events. It's important to note that certain health conditions may prevent you from joining, such as recent cancer, severe heart issues, or specific gastrointestinal diseases. This trial aims to see if colchicine can provide additional benefits for heart health, and your involvement could contribute to valuable research in this area.

Gender

ALL

Eligibility criteria

• 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.