Using low-dose colchicine to treat acute coronary syndromes

Treatment of ACuTe Coronary Syndromes With Low-dose colchICine (TACTIC): a Randomised, Double-blinded, Placebo-controlled, Multicentric Trial

This study tests if adding low-dose colchicine to standard treatment can help people with acute coronary syndromes avoid serious heart problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 6574 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06215989 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of acute coronary syndrome.

Not a fit: Patients with type 2 myocardial infarction or significant valvular heart disease requiring surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of serious cardiovascular events in patients with acute coronary syndromes.

How similar studies have performed: Previous studies have suggested potential benefits of colchicine in cardiovascular conditions, but this specific approach in ACS is still being evaluated.

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.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Xiaoteng Ma, MD — Beijing Anzhen Hospital
• Study coordinator: Yujie Zhou, PhD, MD

Conditions Acute Coronary Syndrome; Unstable Angina; ST Elevation Myocardial Infarction; Non ST Segment Elevation Myocardial Infarction; Colchicine