NCT06215989

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6,574 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 chronic stable coronary artery disease (SCAD) by the American Heart Association (AHA)/American College of Cardiology (ACC) have identified colchicine as the drug of choice for secondary preventive treatment in patients with SCAD to reduce the risk of recurrence of adverse cardiovascular events. Despite the current optimal medical therapies, some ACS patients still suffer recurrent adverse cardiovascular events and mortality. Existing clinical studies have not fully clarified whether early use of colchicine to reduce inflammatory responses is associated with greater clinical benefit after ACS. The effect of colchicine on cardiovascular outcomes in the ACS patients needs further elucidation. Methods: Patients aged 18 years and older with a definite diagnosis of ACS are randomly assigned to two groups in a 1:1 ratio after signing the informed consent form. Colchicine group: standard treatment + colchicine (0.5mg qd) from 1st month to 12th month after randomization. Placebo group: standard treatment + placebo (1 tablet qd) from 1st month to 12th month after randomization. The primary endpoint is the composite of cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operation related) myocardial infarction, readmission for ACS, and ischaemia driven (unplanned) revascularization at 1 year after randomization.

Conditions

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

Interventions

Type	Name	Description
DRUG	Colchicine Pill	Colchicine 0.5mg once daily will be given on the basis of standard treatment of ACS recommended by guidelines
DRUG	Placebo	Placebo one tablet once daily will be given on the basis of standard treatment of ACS recommended by guidelines

Timeline

• Start date: 2024-09-02
• Primary completion: 2027-02-01
• Completion: 2028-06-01
• First posted: 2024-01-22
• Last updated: 2024-10-30

Locations

1 site across 1 country: China