The Effect of Colchicine on Inflammation in ACS Patients

• Status: Completed
• Trial end date: 2022-05-20
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• male or female

• >18 yrs

• STEMI patients who were successfully treated with PCI.

Exclusion Criteria:

• 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