The Effect of Colchicine on Inflammation in ACS Patients

Ain Shams University

Status and phase

Completed

Phase 3

Conditions

Acute Coronary Syndrome

STEMI

Treatments

Drug: Colchicine Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT06054100

2511

Details and patient eligibility

About

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

Full 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 parameters as well as to examine the drug safety and tolerability in these patients.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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