Status:
RECRUITING
Treatment of ACuTe Coronary Syndromes With Low-dose colchICine
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Acute Coronary Syndrome
Unstable Angina
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Background: Colchicine is a cheap and potent oral anti-inflammatory drug that can exert its anti-inflammatory effect on the pathogenesis of ACS. The 2023 updated guidelines for the management of chron...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Definite diagnosis of ACS;
- Ability and willingness to provide written informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
September 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
6574 Patients enrolled
Trial Details
Trial ID
NCT06215989
Start Date
September 2 2024
End Date
June 1 2028
Last Update
October 30 2024
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029