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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

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

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

anna.toso@libero.it

First Name & Middle Initial & Last Name or Official Title & Degree

Mario Leoncini, MD

Phone

0039 574 803732

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

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

marco.comeglio@uslcentro.toscana.it

First Name & Middle Initial & Last Name & Degree

Francesco Biagini, MD

Phone

0039 573351027

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

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

Learn more about this trial

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

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