RecruitingPhase 3ACTRN12616000400460

The effect of Colchicine on Cardiovascular Outcomes in Acute Coronary Syndrome Study (The COLCARDIO-ACS Study)

The COLCARDIO-ACS Study - Colchicine Cardiovascular Outcomes in Acute Coronary Syndrome Study


Sponsor

University of Sydney

Enrollment

3,000 participants

Start Date

Jan 27, 2022

Study Type

Interventional

Conditions

Summary

COLCARDIO-ACS Main study: Inflammation plays a pivotal role in atherosclerosis, offering new opportunities for the prevention and treatment of coronary artery disease. Colchicine is a commonly used anti-inflammatory medication approved for the treatment of gout, Familial Mediterranean Fever, and acute/recurrent pericarditis. There is an increasing body of evidence in the medical literature supporting a beneficial role of long term colchicine therapy in prevention of cardiovascular disease, via modulation of inflammatory cytokine production and tubulin-mediated mitosis inhibition. This includes both primary prevention in patients treated with colchicine for gout or Familial Mediterranean Fever, and secondary prevention in patients with stable coronary artery disease who are also being treated with statins and anti-platelet agents. Low-dose colchicine use has also been proven to be safe, well tolerated, and is inexpensive and readily available. The aim of this project is to assess the effect of colchicine (0.5 mg/day) in addition to optimal medical therapy on cardiovascular outcomes in ACS patients with evidence of persistent coronary inflammation (based on hsCRP). We hypothesise that addition of colchicine to optimal medical therapy in patients post-ACS, who have biomarker evidence of persistent inflammation will reduce recurrent cardiovascular events. COLCHICINE-COG Sub-study: Dementia affects over 400,000 Australians at a cost to the economy of $30 billion per year and is a Commonwealth Government National Health Priority. It is the third leading cause of death overall and the largest reason for disability in older Australians. Cardiovascular disease (CVD) has been identified as the earliest and strongest pathological marker for dementia. Oxidative stress is characterised by an imbalance in the redox state of cells (either via the overproduction of reactive oxygen species of antioxidant system dysfunction) and is posited to be a key mechanistic pathway underpinning the relationship between CVD and cognitive decline. Importantly, research suggests that the pathology leading to dementia occurs 10-20 years before the onset of clinical symptoms. Therefore, it is critical that interventions target CVD in those ‘at risk’ to prevent onset and reduce cognitive decline. The aim of this study is to examine the effect of long term low-dose colchicine on cognition and brain health patients with established coronary artery disease.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a low-dose anti-inflammatory medication called colchicine — which is already used to treat gout and other conditions — can help prevent a second heart attack or other serious heart events in people who have recently had an acute coronary syndrome (ACS), such as a heart attack or severe unstable angina. Inflammation in the arteries plays a big role in heart disease, and colchicine may be able to lower that inflammation and protect the heart. A sub-study also looks at whether colchicine can protect brain health and slow cognitive (memory/thinking) decline. You may be eligible if: - You are 18 years or older - You have recently been hospitalised for a heart attack or high-risk unstable angina - You are currently on optimal heart medications - You have a blood marker called hs-CRP of 2 mg/L or higher, indicating ongoing inflammation - You are willing to comply with all study visits and requirements You may NOT be eligible if: - You have a known intolerance or allergy to colchicine - You have a serious liver, kidney, or muscle condition - You have an active autoimmune disease or chronic inflammatory bowel disease - You are pregnant, breastfeeding, or not using contraception - You have a life expectancy of less than 3 years - You are taking certain medications that interact with colchicine Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Oral Colchicine 0.5 mg tablet taken daily for median of 3 years. Eligible and consenting participants will be registered and then commenced on Run-In treatment consisting of 1 oral tablet (0.5mg of co

Oral Colchicine 0.5 mg tablet taken daily for median of 3 years. Eligible and consenting participants will be registered and then commenced on Run-In treatment consisting of 1 oral tablet (0.5mg of colchicine) a day for 28 days additional to standard of care medication prescribed by treating physician. The Run-In treatment will be dispensed to participants in a single blinded manner. Upon completion of the Run-In treatment participants will be asked to return to site for a safety and compliance check before being randomised to receive either oral Colchicine 0.5mg taken daily or matched oral Placebo tablet taken daily for a median of 3 years and 600 primary endpoint events have occurred. Ongoing study treatment will be dispensed on a 6 monthly basis and participants will attend annual in clinic visits for clinical assessments and compliance check. Eligible and consenting participants to the COLCHICINE-COG sub study will have additional assessments including 30-minute online neuropsychological assessments (baseline, 12, 24 and 36 months), blood collection performed at the same time as collection for the main study (baseline, 12 and 36 months) and 30-60 minute MRI assessments in a sub-set of participants (n=40) at baseline and 12 months.


Locations(16)

Royal Prince Alfred Hospital - Camperdown

NSW,QLD,WA,VIC, Australia

Concord Repatriation Hospital - Concord

NSW,QLD,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,WA,VIC, Australia

Royal North Shore Hospital - St Leonards

NSW,QLD,WA,VIC, Australia

Royal Perth Hospital - Perth

NSW,QLD,WA,VIC, Australia

Blacktown Hospital - Blacktown

NSW,QLD,WA,VIC, Australia

Cairns Base Hospital - Cairns

NSW,QLD,WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

NSW,QLD,WA,VIC, Australia

Gold Coast University Hospital - Southport

NSW,QLD,WA,VIC, Australia

Gosford Hospital - Gosford

NSW,QLD,WA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,WA,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,QLD,WA,VIC, Australia

Nepean Hospital - Kingswood

NSW,QLD,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,WA,VIC, Australia

Wollongong Hospital - Wollongong

NSW,QLD,WA,VIC, Australia

Santiago, Chile

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ACTRN12616000400460


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