Status:
COMPLETED
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
Lead Sponsor:
Azienda USL Toscana Centro
Conditions:
Non ST Segment Elevation Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 colchicin...
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...
Eligibility Criteria
Inclusion
- non-ST elevation acute coronary syndrome;
- ≥ 18 years;
- statin-naive.
Exclusion
- 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.
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT05250596
Start Date
February 24 2022
End Date
May 30 2024
Last Update
July 16 2024
Active Locations (3)
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1
Gaia Chiara Selvaggia Magnaghi
Pescia, Italy, 59100
2
Marco Comeglio
Pistoia, Italy, 51100
3
Anna Toso
Prato, Italy, 59100