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

NCT ID: NCT05250596

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2024-05-30

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.

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colchicine and Atorvastatin

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.

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

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

Atorvastatin

Intervention Type: DRUG

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

Atorvastatin

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

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

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

Interventions

Colchicine

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

Intervention Type: DRUG

Atorvastatin

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Toscana Centro

OTHER

Sponsor Role: lead

Responsible Party

Anna Toso

Cardiologist at the Santo Stefano Hospital, Prato, Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anna Toso, MD

Role: PRINCIPAL_INVESTIGATOR

Santo Stefano Hospital, Prato, Italy

Locations

Gaia Chiara Selvaggia Magnaghi

Pescia, , Italy

Marco Comeglio

Pistoia, , Italy

Anna Toso

Prato, , Italy

Countries

Italy

References

Toso A, Leoncini M, Magnaghi G, Biagini F, Martini O, Maioli M, Villani S, Comeglio M, Bellandi F. Rationale and design of COLchicine On-admission to Reduce inflammation in Acute Coronary Syndrome (COLOR-ACS) study. J Cardiovasc Med (Hagerstown). 2023 Jan 1;24(1):52-58. doi: 10.2459/JCM.0000000000001389. Epub 2022 Nov 29.

Reference Type: DERIVED

PMID: 36473121 (View on PubMed)

Other Identifiers

2021-000637-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID 20426

Identifier Type: -

Identifier Source: org_study_id