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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000637-13 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Atorvastatin | Active Comparator | Atorvastatin 80 mg on admission followed by 80 mg/day until discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 1 mg (0.5 mg for patients ≤ 70 Kg) on-admission followed by 0.5 mg/day until discharge. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Delta variation in creatinine value from baseline to peak | Delta variation (absolute and relative) in creatinine value from baseline value to peak value | Creatinine value is measured daily during hospitalization - average 4 days |
| Acute kidney injury incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Toso, MD | Santo Stefano Hospital, Prato, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gaia Chiara Selvaggia Magnaghi | Pescia | 59100 | Italy | |||
| Marco Comeglio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36473121 | Derived | 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. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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Participants are assigned to Colchicine plus standard treatment with Atorvastatin or only standard treatment with Atorvastatin
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| Atorvastatin | Drug | Atorvastatin 80 mg on admission followed by 80 mg/day until discharge. |
|
Creatinine increase >= 0.3 mg/dl within 48 hours after angiography |
| Creatinine value is measured daily during hospitalization - average 4 days |
| CK-MB peak value | Comparison of CK-MB peak values in the two arms | 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 | 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 | Approximately 30 days |
| Tolerance to colchicine | Percentage of patients who do not manifest side effects to colchicine treatment | From admission to discharge - Approximately 4 days |
| Pistoia |
| 51100 |
| Italy |
| Anna Toso | Prato | 59100 | Italy |
| D051437 |
| Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |