Non ST Segment Elevation Acute Coronary Syndrome
Conditions
Keywords
Colchicine, Atorvastatin, Acute Coronary Syndrome, C reactive protein, Acute Kidney Injury
Brief summary
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.
Detailed description
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.
Interventions
DRUGColchicine
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge.
DRUGAtorvastatin
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
Sponsors
Azienda USL Toscana Centro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* non-ST elevation acute coronary syndrome; * ≥ 18 years; * statin-naive.
Exclusion criteria
* prior statin therapy and/or colchicine treatment; * known allergy or hypersensitivity to colchicine or statins; * current treatment with potent inhibitors of CYP3A4 or P-glycoprotein (eg., Cyclosporin, antiretroviral drugs, antimycotics, erythromicin and clarythromycin); * previous or scheduled administration of any immunosuppressive therapy; * known active malignancy; * severe kidney disease (creatinine \> 3 mg/dl or dialysis) * severe liver disease (ALT and/or AST, \> double ref. normal values in case of (a) total bilirubin \> double ref. normal values, or (b) alteration in coagulation (INR\> 1,5); * severe heart failure (NYHA class ≥ 3 or cardiogenic shock) at hospital presentation; * severe acute or chronic gastro-intestinal disease (nausea, vomiting, diarrhea, malabsorption disease, malnutrition); * pregnancy or lactation; * current COVID-19 or other infectious disease; * refusal of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hsCRP change between admission and discharge | Average 4 days: from admission to discharge | Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute kidney injury incidence | Creatinine value is measured daily during hospitalization - average 4 days | Creatinine increase \>= 0.3 mg/dl within 48 hours after angiography |
| CK-MB peak value | CK-MB value is measured daily during hospitalization - average 4 days | Comparison of CK-MB peak values in the two arms |
| Delta variation in creatinine value from baseline to peak | Creatinine value is measured daily during hospitalization - average 4 days | Delta variation (absolute and relative) in creatinine value from baseline value to peak value |
| Adverse clinical events from admission to 30 days after discharge | Approximately 30 days | Myocardial infarction, glomerular filtration rate deterioration or all-cause death from admission to 30 days after discharge |
| Tolerance to colchicine | From admission to discharge - Approximately 4 days | Percentage of patients who do not manifest side effects to colchicine treatment |
| Glomerular filtration rate changes at 30 days after discharge | Approximately 30 days | Delta variation in the glomerular filtration rate from baseline to 30 days after discharge |
Countries
Italy
Outcome results
None listed