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
University of Sydney
1,500 participants
Mar 3, 2023
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
Plain Language Summary
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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 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)
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ACTRN12621001408875