COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)

Azienda USL Toscana Centro

Status and phase: Completed; Phase 2

Conditions: Non ST Segment Elevation Acute Coronary Syndrome

Treatments: Drug: Atorvastatin; Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05250596

ID 20426

2021-000637-13 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 2 patient groups

Colchicine and Atorvastatin

Experimental group

Description:

Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge plus Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.

Treatment:

Drug: Colchicine

Drug: Atorvastatin

Atorvastatin

Active Comparator group

Description:

Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.

Treatment:

Drug: Atorvastatin