Since colchicine is known to have anti-inflammatory effects and inflammation is an early component of acute coronary syndrome (ACS), this study aims to evaluate the acute effects of low-dose colchicine, in addition to atorvastatin, administered on-admission to statin-naive patients with non-ST elevation ACS scheduled for early invasive strategy.
On-admission all statin naive NSTEACS patients are randomized to receive either standard treatment of atorvastatin 80 mg or standard treatment plus colchicine (1 mg loading dose followed by 0.5 mg/day). Inflammatory biomarker high sensitivity C reactive protein (hs-CRP) is measured in all patients on-admission and every 24 hours thereafter until discharge. Cardiac and renal function parameters are evaluated to evidence the possible beneficial effects of the administration of colchicine in addition to atorvastatin alone both short- and medium-term (up to 30 days). Colchicine tolerance is also investigated through monitoring for clinical side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge.
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
Gaia Chiara Selvaggia Magnaghi
Pescia, Italy
Marco Comeglio
Pistoia, Italy
Anna Toso
Prato, Italy
hsCRP change between admission and discharge
Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone
Time frame: Average 4 days: from admission to discharge
Delta variation in creatinine value from baseline to peak
Delta variation (absolute and relative) in creatinine value from baseline value to peak value
Time frame: Creatinine value is measured daily during hospitalization - average 4 days
Acute kidney injury incidence
Creatinine increase \>= 0.3 mg/dl within 48 hours after angiography
Time frame: Creatinine value is measured daily during hospitalization - average 4 days
CK-MB peak value
Comparison of CK-MB peak values in the two arms
Time frame: CK-MB value is measured daily during hospitalization - average 4 days
Glomerular filtration rate changes at 30 days after discharge
Delta variation in the glomerular filtration rate from baseline to 30 days after discharge
Time frame: Approximately 30 days
Adverse clinical events from admission to 30 days after discharge
Myocardial infarction, glomerular filtration rate deterioration or all-cause death from admission to 30 days after discharge
Time frame: Approximately 30 days
Tolerance to colchicine
Percentage of patients who do not manifest side effects to colchicine treatment
Time frame: From admission to discharge - Approximately 4 days
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