Clinical trial
On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
Name
ID 20426
Description
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.
Trial arms
Trial start
2022-02-24
Estimated PCD
2023-09-24
Trial end
2023-12-30
Status
Recruiting
Phase
Early phase I
Treatment
Colchicine
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge.
Arms:
Colchicine and Atorvastatin
Atorvastatin
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
Arms:
Atorvastatin, Colchicine and Atorvastatin
Size
175
Primary endpoint
hsCRP change between admission and discharge
Average 4 days: from admission to discharge
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 175, 'type': 'ESTIMATED'}}
Updated at
2023-03-08
1 organization
1 product
1 drug
1 indication
Organization
Azienda USL Toscana CentroProduct
ColchicineDrug
Atorvastatin