COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS) (COLOR-ACS)
Primary Purpose
Non ST Segment Elevation Acute Coronary Syndrome
Status
Recruiting
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Colchicine
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Non ST Segment Elevation Acute Coronary Syndrome focused on measuring Colchicine, Atorvastatin, Acute Coronary Syndrome, C reactive protein, Acute Kidney Injury
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.
Sites / Locations
- Gaia Chiara Selvaggia MagnaghiRecruiting
- Marco ComeglioRecruiting
- Anna TosoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Colchicine and Atorvastatin
Atorvastatin
Arm 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.
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
Outcomes
Primary Outcome Measures
hsCRP change between admission and discharge
Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone
Secondary Outcome Measures
Delta variation in creatinine value from baseline to peak
Delta variation (absolute and relative) in creatinine value from baseline value to peak value
Acute kidney injury incidence
Creatinine increase >= 0.3 mg/dl within 48 hours after angiography
CK-MB peak value
Comparison of CK-MB peak values in the two arms
Glomerular filtration rate changes at 30 days after discharge
Delta variation in the glomerular filtration rate from baseline to 30 days after discharge
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
Tolerance to colchicine
Percentage of patients who do not manifest side effects to colchicine treatment
Full Information
NCT ID
NCT05250596
First Posted
February 8, 2022
Last Updated
March 7, 2023
Sponsor
Azienda USL Toscana Centro
1. Study Identification
Unique Protocol Identification Number
NCT05250596
Brief Title
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
Acronym
COLOR-ACS
Official Title
On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
September 24, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda USL Toscana Centro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non ST Segment Elevation Acute Coronary Syndrome
Keywords
Colchicine, Atorvastatin, Acute Coronary Syndrome, C reactive protein, Acute Kidney Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colchicine and Atorvastatin
Arm Type
Experimental
Arm 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.
Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Description
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
Primary Outcome Measure Information:
Title
hsCRP change between admission and discharge
Description
Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone
Time Frame
Average 4 days: from admission to discharge
Secondary Outcome Measure Information:
Title
Delta variation in creatinine value from baseline to peak
Description
Delta variation (absolute and relative) in creatinine value from baseline value to peak value
Time Frame
Creatinine value is measured daily during hospitalization - average 4 days
Title
Acute kidney injury incidence
Description
Creatinine increase >= 0.3 mg/dl within 48 hours after angiography
Time Frame
Creatinine value is measured daily during hospitalization - average 4 days
Title
CK-MB peak value
Description
Comparison of CK-MB peak values in the two arms
Time Frame
CK-MB value is measured daily during hospitalization - average 4 days
Title
Glomerular filtration rate changes at 30 days after discharge
Description
Delta variation in the glomerular filtration rate from baseline to 30 days after discharge
Time Frame
Approximately 30 days
Title
Adverse clinical events from admission to 30 days after discharge
Description
Myocardial infarction, glomerular filtration rate deterioration or all-cause death from admission to 30 days after discharge
Time Frame
Approximately 30 days
Title
Tolerance to colchicine
Description
Percentage of patients who do not manifest side effects to colchicine treatment
Time Frame
From admission to discharge - Approximately 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Toso, MD
Phone
0039 574 803732
Email
anna.toso@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Leoncini, MD
Phone
0039 574 803732
Email
leoncini.mario@tiscali.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Toso, MD
Organizational Affiliation
Santo Stefano Hospital, Prato, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaia Chiara Selvaggia Magnaghi
City
Pescia
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaia CS Magnaghi, MD
Phone
0039 572460254
Email
gaiachiaraselvaggia.magnaghi@uslcentro.toscana.it
First Name & Middle Initial & Last Name & Degree
Duccio Rossini, MD
Facility Name
Marco Comeglio
City
Pistoia
ZIP/Postal Code
51100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Comeglio, MD
Phone
0039 5733521
Email
marco.comeglio@uslcentro.toscana.it
First Name & Middle Initial & Last Name & Degree
Francesco Biagini, MD
Phone
0039 573351027
Email
francesco.biagini@uslcentro.toscana.it
First Name & Middle Initial & Last Name & Degree
Francesco Biagini, MD
Facility Name
Anna Toso
City
Prato
ZIP/Postal Code
59100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Toso, MD
Phone
0039 574803732
Email
anna.toso@libero.it
First Name & Middle Initial & Last Name & Degree
Mario Leoncini, MD
First Name & Middle Initial & Last Name & Degree
Mauro Maioli, MD
First Name & Middle Initial & Last Name & Degree
Elisa Vignini, MD
First Name & Middle Initial & Last Name & Degree
Francesco Pestelli, MD
First Name & Middle Initial & Last Name & Degree
Gabriele Grippo, MD
First Name & Middle Initial & Last Name & Degree
Massimiliano Nieri, MD
First Name & Middle Initial & Last Name & Degree
Francesco Bellandi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
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