Non ST Segment Elevation Acute Coronary SyndromePhase 2COLOR-ACSNCT05250596
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
A Phase 2 study testing Colchicine and Atorvastatin in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Azienda USL Toscana Centro at 3 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non ST Segment Elevation Acute Coronary Syndrome
- What is being tested?
- Colchicine and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 3 sitesItaly
- Study dates
- 24 Feb 2022to 30 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-ST elevation acute coronary syndrome;
- ≥ 18 years;
- statin-naive.
Who cannot join
- 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)
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- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Gaia Chiara Selvaggia Magnaghi
Pescia, 59100
Marco Comeglio
Pistoia, 51100
Anna Toso
Prato, 59100
About this study
Official title: On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
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.
Read the 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.
- Being tested
- Colchicine, Atorvastatin
- Keywords
- Colchicine, Atorvastatin, Acute Coronary Syndrome, C reactive protein, Acute Kidney Injury
- Medical subject headings
- Acute Coronary Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge.
AtorvastatinDrug
Atorvastatin 80 mg on admission followed by 80 mg/day until discharge.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Colchicine; Drug: Atorvastatin |
| Atorvastatin | Active comparator | Atorvastatin 80 mg on admission followed by 80 mg/day until discharge. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
hsCRP change between admission and discharge
Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone
Measured: Average 4 days: from admission to discharge
Secondary outcomes (6)
Delta variation in creatinine value from baseline to peak
Delta variation (absolute and relative) in creatinine value from baseline value to peak value
Measured: Creatinine value is measured daily during hospitalization - average 4 days
Acute kidney injury incidence
Creatinine increase >= 0.3 mg/dl within 48 hours after angiography
Measured: Creatinine value is measured daily during hospitalization - average 4 days
CK-MB peak value
Comparison of CK-MB peak values in the two arms
Measured: CK-MB value is measured daily during hospitalization - average 4 days
Glomerular filtration rate changes at 30 days after discharge
Delta variation in the glomerular filtration rate from baseline to 30 days after discharge
Measured: Approximately 30 days
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
Measured: Approximately 30 days
Tolerance to colchicine
Percentage of patients who do not manifest side effects to colchicine treatment
Measured: From admission to discharge - Approximately 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start24 Feb 2022
- Primary completion24 Feb 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non ST Segment Elevation Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Centro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Toso, Azienda USL Toscana Centro
- Investigators
- Anna Toso, MD, Principal investigator, Santo Stefano Hospital, Prato, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250596
- Sponsor's protocol ID
- ID 20426
- Other IDs
- 2021-000637-13
- Acronym
- COLOR-ACS
- Status last verified
- Jul 2024
- First submitted
- 8 Feb 2022
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36473121
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT05250596
- Acronym / sponsor ID
- COLOR-ACS / ID 20426
- Keywords
- Colchicine, Atorvastatin, Acute Coronary Syndrome, C reactive protein, Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Azienda USL Toscana CentroUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 24 Feb 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin
| Arm | Type | Receives |
|---|---|---|
| Colchicine and Atorvastatin | Experimental | Drug: Colchicine, Drug: AtorvastatinColchicine 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 | Active comparator | Drug: AtorvastatinAtorvastatin 80 mg on admission followed by 80 mg/day until discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-ST elevation acute coronary syndrome;
- ≥ 18 years;
- statin-naive.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge. | Drug | Colchicine and Atorvastatin |
| AtorvastatinAtorvastatin 80 mg on admission followed by 80 mg/day until discharge. | Drug | Atorvastatin, Colchicine and Atorvastatin |
Primary outcome
hsCRP change between admission and discharge
Time frame: Average 4 days: from admission to discharge
Effect of colchicine plus atorvastatin in limiting hsCRP changes compared to atorvastatin alone
6 secondary outcomes
Delta variation in creatinine value from baseline to peak
Time frame: Creatinine value is measured daily during hospitalization - average 4 days
Acute kidney injury incidence
Time frame: Creatinine value is measured daily during hospitalization - average 4 days
CK-MB peak value
Time frame: CK-MB value is measured daily during hospitalization - average 4 days
Glomerular filtration rate changes at 30 days after discharge
Time frame: Approximately 30 days
Adverse clinical events from admission to 30 days after discharge
Time frame: Approximately 30 days
Tolerance to colchicine
Time frame: From admission to discharge - Approximately 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Derived from this study: PubMed 36473121Toso 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Toso, MD principal investigator
Santo Stefano Hospital, Prato, Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine and Atorvastatin in people with Non ST Segment Elevation Acute Coronary Syndrome, run by Azienda USL Toscana Centro at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hsCRP change between admission and discharge (time frame: Average 4 days: from admission to discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05250596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.