Status:
COMPLETED
The Effect of Colchicine on Inflammation in ACS Patients
Lead Sponsor:
Ain Shams University
Conditions:
Acute Coronary Syndrome
STEMI
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients
Detailed Description
This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameter...
Eligibility Criteria
Inclusion
- male or female
- \>18 yrs
- STEMI patients who were successfully treated with PCI.
Exclusion
- Pregnant or breast-feeding women or women of childbearing potential.
- Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
- Known hypersensitivity to colchicine or current chronic treatment with colchicine.
- Severe renal failure (estimated creatinine clearance \<30ml/min) or hepatic failure (Child Pugh score B or C )
- Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
- Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT06054100
Start Date
February 1 2020
End Date
May 20 2022
Last Update
September 26 2023
Active Locations (1)
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1
Ain shams university
Cairo, Egypt