RecruitingNot ApplicableNCT06215989

Treatment of ACuTe Coronary Syndromes With Low-dose colchICine

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


Sponsor

Beijing Anzhen Hospital

Enrollment

6,574 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

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 with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Age ≥ 18 years;
  • Definite diagnosis of ACS;
  • Ability and willingness to provide written informed consent

Exclusion Criteria15

  • 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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Interventions

DRUGColchicine Pill

Colchicine 0.5mg once daily will be given on the basis of standard treatment of ACS recommended by guidelines

DRUGPlacebo

Placebo one tablet once daily will be given on the basis of standard treatment of ACS recommended by guidelines


Locations(1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

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NCT06215989


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