NCT05250596CompletedPhase 2
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome (COLOR-ACS)
On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 182 (actual)
- First submitted
- 8 Feb 2022
- Start date
- 24 Feb 2022
- Primary completion date
- 24 Feb 2024
- Lead sponsor
- Azienda USL Toscana Centro
- Diseases
- Coronary artery disease
- NCT number
- NCT05250596
- EudraCT number
- 2021-000637-13
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 182
- From 24 Feb 2022 to the primary completion date, 24 Feb 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior statin therapy and/or colchicine treatment;
- 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;
Other illness
- known allergy or hypersensitivity to colchicine or statins;
- known active malignancy;
- 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);
- current COVID-19 or other infectious disease;
Lab values
- 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);
Other
- pregnancy or lactation;
- refusal of consent.
Who the study is looking for
- non-ST elevation acute coronary syndrome;
- ≥ 18 years;
- statin-naive.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gaia Chiara Selvaggia Magnaghi Coordinator of this site? Confirm its status | Pescia | Italy | Unknown status |
| Marco Comeglio Coordinator of this site? Confirm its status | Pistoia | Italy | Unknown status |
| Anna Toso Coordinator of this site? Confirm its status | Prato | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.