Using low-dose colchicine to treat acute coronary syndromes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of low-dose colchicine in addition to standard treatment for patients with acute coronary syndromes (ACS). It is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to determine if colchicine can further reduce the risk of major adverse cardiovascular events. Patients aged 18 and older with a definite diagnosis of ACS will be randomly assigned to receive either colchicine or a placebo for one year. The primary endpoint is a composite of serious cardiovascular events, including death and non-fatal heart attacks.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xiaoteng Ma, MD — Beijing Anzhen Hospital
• Study coordinator: Yujie Zhou, PhD, MD
• Email: azzyj12@163.com
• Phone: 8613901330652

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.