RecruitingPhase 3ACTRN12621001408875

The effect of Colchicine on Cardiovascular Outcomes in Stroke Study (The CASPER Study)

Colchicine After Stroke Event to Prevent Event Recurrence (CASPER): A randomised trial to evaluate the efficacy of oral Colchicine in high-risk patients with atherosclerosis-associated inflammation post-Stroke


Sponsor

University of Sydney

Enrollment

1,500 participants

Start Date

Mar 3, 2023

Study Type

Interventional

Conditions

Summary

Inflammation is a key component in the cause of ischemic stroke. 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 literature supporting a beneficial role of long-term colchicine therapy in prevention of cardiovascular disease. Low-dose colchicine use has also been proven to be safe, well tolerated and is inexpensive and readily available. The aim of this trial is to assess the effect of low-dose colchicine (0.5mg/daily) in addition to optimal medical therapy of cardiovascular outcomes in stroke patients with evidence of persistent coronary inflammation (based on hs-CRP). We hypothesise that addition of colchicine to optimal medical therapy in patients post-stroke, who have biomarker evidence of persistent inflammation will reduce recurrent cardiovascular events.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is exploring whether a common anti-inflammatory medication called colchicine — already used for gout and other conditions — can help prevent future heart attacks and strokes in people who have recently had a stroke. Researchers believe that ongoing inflammation in the body plays a key role in causing strokes to recur, and colchicine's ability to calm that inflammation may offer protection. The CASPER study is testing a low daily dose of colchicine (0.5mg) on top of standard stroke medications. To be eligible, participants must have had an ischemic stroke or a TIA (mini-stroke) within the past year, have only mild disability, and show a blood marker indicating their body still has elevated inflammation. The treatment is taken as a once-daily tablet, and the trial follows participants over time to measure whether they have fewer cardiovascular events compared to those not taking colchicine. Colchicine is inexpensive, widely available, and has a well-established safety record. This trial could open the door to a simple, affordable way to protect stroke survivors from suffering another event. You may be eligible if you are 18 or older, have had a recent ischemic stroke or TIA with evidence of inflammation in your blood, and do not have severe kidney or liver problems.

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. 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.


Locations(9)

Royal Prince Alfred Hospital - Camperdown

NSW, Australia

The Alfred - Melbourne

NSW, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW, Australia

Prince of Wales Hospital - Randwick

NSW, Australia

Box Hill Hospital - Box Hill

NSW, Australia

John Hunter Hospital - New Lambton

NSW, Australia

Liverpool Hospital - Liverpool

NSW, Australia

Princess Alexandra Hospital - Woolloongabba

NSW, Australia

Royal Brisbane & Womens Hospital - Herston

NSW, Australia

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ACTRN12621001408875


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