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

NCT05250596 | Completed Phase 2

• 2 other identifiers: ID 204262021-000637-13
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 3

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.

Conditions

Non ST Segment Elevation Acute Coronary Syndrome

Keywords

Colchicine; Atorvastatin; Acute Coronary Syndrome; C reactive protein; Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Delta variation in creatinine value from baseline to peak

  Creatinine value is measured daily during hospitalization - average 4 days

• Acute kidney injury incidence

  Creatinine value is measured daily during hospitalization - average 4 days

• CK-MB peak value

  CK-MB value is measured daily during hospitalization - average 4 days

• Glomerular filtration rate changes at 30 days after discharge

  Approximately 30 days

• Adverse clinical events from admission to 30 days after discharge

  Approximately 30 days

Study Arms (2)

Colchicine and Atorvastatin

EXPERIMENTAL

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.

Drug: Colchicine; Drug: Atorvastatin

Atorvastatin

ACTIVE COMPARATOR

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

Drug: Atorvastatin

Interventions

Colchicine DRUG

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

Colchicine and Atorvastatin

Atorvastatin DRUG

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

Atorvastatin; Colchicine and Atorvastatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-ST elevation acute coronary syndrome;
• ≥ 18 years;
• statin-naive.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda USL Toscana Centro: lead

Study Sites (3)

Gaia Chiara Selvaggia Magnaghi

Pescia, 59100, Italy

Location

Marco Comeglio

Pistoia, 51100, Italy

Location

Anna Toso

Prato, 59100, Italy

Location

Related Publications (1)

• 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.

  PMID: 36473121 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Acute Kidney Injury

Interventions

Colchicine; Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Anna Toso, MD

  Santo Stefano Hospital, Prato, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist at the Santo Stefano Hospital, Prato, Italy

Model Details: Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 22, 2022
• Study Start: February 24, 2022
• Primary Completion: February 24, 2024
• Study Completion: May 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)