The aim is to determine whether giving a daily low dose colchicine on top of standard medical care reduces the rate of repeat cardiac events.

 

Trial Summary:

One Australian dies from an acute coronary syndrome (ACS) every 51 minutes; it is the leading cause of death worldwide, and of disease burden in high income countries. Despite current best treatments many people remain at high risk of future heart attacks, predominantly because current therapies do not specifically target the inflammatory component of atherosclerosis. The landmark CANTOS study showed Canakinumab (a drug targeting this inflammation around the heart) reduced repeat cardiovascular events in high risk patients, however Canakinumab is expensive to produce and not well tolerated. Colchicine is an approved anti-inflammatory treatment for gout and is also commonly used in treating pericarditis. It is inexpensive, well tolerated and readily available.

The COLCARDIO-ACS study lead by Professor Anthony Keech and Associate Professor Sanjay Patel at the NHMRC Clinical Trials Centre, University of Sydney will investigate the role of colchicine in secondary prevention of cardiac events after an Acute Coronary Syndrome (ACS) event. The aim is to determine whether giving daily low dose colchicine on top of standard medical care reduces the rate of repeat cardiac events.  The study will be conducted in 3000 adults from Australia and overseas who have experienced an ACS event and have persistently high levels of inflammatory marker by hs-CRP>2mg/L at 4-6 weeks after the initial ACS event. These individuals are at highest risk of having another cardiac event and who are expected to get the most benefit from colchicine. Participants will receive either oral colchicine 0.5mg or matched placebo tablet taken daily for 3 years. All participants will be followed up regularly for an average of 3 years and information about cardiac events will be collected.   

The results of this trial will contribute a major addition to the evidence about treating this high risk group, over and above ongoing trials, and will provide a cheap and effective therapy option to those with the greatest need.

Supported By:

National Health and Medical Research Council (NHMRC)

Eligibility:

Adults (aged ≥ 18 years) who have experienced an ACS event (defined as acute myocardial infarction, with or without electrocardiographic evidence of ST-segment elevation, or high-risk unstable angina) and hs-CRP >2 mg/L at 4-6 weeks post event.

Registration ID:

ACTRN12616000400460

Participation:

A target population of 3000 participants who have experienced an Acute Coronary S event (defined as acute myocardial infarction, with or without electrocardiographic evidence of ST-segment elevation, or high-risk unstable angina) and hs-CRP >2 mg/L at 4-6 weeks post event.

Australian Lead Group:

CTC

Status:

Study Start Up (not yet recruiting)

Activation Date:

Anticipated 31 Oct 2020

Chairs:

Prof Tony Keech

Contact:

COLCARDIO-ACS@ctc.usyd.edu.au