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

Non ST Segment Elevation Acute Coronary Syndrome Clinical Trial

— COLOR-ACS  

Official title:

On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05250596
• Other study ID #: ID 20426
• Secondary ID: 2021-000637-13
• Status: Recruiting
• Phase: Phase 2
• Start date: February 24, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Azienda USL Toscana Centro
• Contact: Anna Toso, MD
• Phone: 0039 574 803732
• Email: anna.toso[@]libero.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 175
• Est. completion date: December 30, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Inflammation
• Non ST Segment Elevation Acute Coronary Syndrome
• Syndrome

Intervention

Drug:
• Colchicine
Colchicine 1 mg (0.5 mg for patients = 70 Kg) on-admission followed by 0.5 mg/day until discharge.
• Atorvastatin
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.

Locations

Country	Name	City	State
Italy	Gaia Chiara Selvaggia Magnaghi	Pescia
Italy	Marco Comeglio	Pistoia
Italy	Anna Toso	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Azienda USL Toscana Centro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hsCRP change between admission and discharge	Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone	Average 4 days: from admission to discharge
Secondary	Delta variation in creatinine value from baseline to peak	Delta variation (absolute and relative) in creatinine value from baseline value to peak value	Creatinine value is measured daily during hospitalization - average 4 days
Secondary	Acute kidney injury incidence	Creatinine increase >= 0.3 mg/dl within 48 hours after angiography	Creatinine value is measured daily during hospitalization - average 4 days
Secondary	CK-MB peak value	Comparison of CK-MB peak values in the two arms	CK-MB value is measured daily during hospitalization - average 4 days
Secondary	Glomerular filtration rate changes at 30 days after discharge	Delta variation in the glomerular filtration rate from baseline to 30 days after discharge	Approximately 30 days
Secondary	Adverse clinical events from admission to 30 days after discharge	Myocardial infarction, glomerular filtration rate deterioration or all-cause death from admission to 30 days after discharge	Approximately 30 days
Secondary	Tolerance to colchicine	Percentage of patients who do not manifest side effects to colchicine treatment	From admission to discharge - Approximately 4 days