Clinical trial NCT05250596: COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
Official title: On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non ST Segment Elevation Acute Coronary Syndrome
Keywords: Colchicine
Atorvastatin
Acute Coronary Syndrome
C reactive protein
Acute Kidney Injury
Lead sponsor: Azienda USL Toscana Centro
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: hsCRP change between admission and discharge
timeFrame: Average 4 days: from admission to discharge
Secondary outcomes:
measure: Delta variation in creatinine value from baseline to peak
timeFrame: Creatinine value is measured daily during hospitalization - average 4 days
measure: Acute kidney injury incidence
timeFrame: Creatinine value is measured daily during hospitalization - average 4 days
measure: CK-MB peak value
timeFrame: CK-MB value is measured daily during hospitalization - average 4 days
measure: Glomerular filtration rate changes at 30 days after discharge
timeFrame: Approximately 30 days
measure: Adverse clinical events from admission to 30 days after discharge
timeFrame: Approximately 30 days
measure: Tolerance to colchicine
timeFrame: From admission to discharge - Approximately 4 days
Other outcomes:
Locations:
city: Pescia
country: Italy
facility: Gaia Chiara Selvaggia Magnaghi
city: Pistoia
country: Italy
facility: Marco Comeglio
city: Prato
country: Italy
facility: Anna Toso
Study officials:
affiliation: Santo Stefano Hospital, Prato, Italy
name: Anna Toso, MD
role: PRINCIPAL_INVESTIGATOR
References: