The Effect of Colchicine on Inflammation in ACS Patients

Last updated: September 22, 2023
Sponsor: Ain Shams University
Overall Status: Completed

Phase

3

Condition

Inflammation

Heart Disease

Coronary Artery Disease

Treatment

Colchicine Tablets

Clinical Study ID

NCT06054100
2511
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • male or female
  • >18 yrs
  • STEMI patients who were successfully treated with PCI.

Exclusion

Exclusion Criteria:

  • Pregnant or breast-feeding women or women of childbearing potential.
  • Active inflammatory, known malignancy, infectious diseases or current treatment withcorticosteroids 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 myocardialinfarction.
  • Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir,clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gpinhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine,verapamil, ketoconazole, itraconazole) and grape fruit juice

Study Design

Total Participants: 88
Treatment Group(s): 1
Primary Treatment: Colchicine Tablets
Phase: 3
Study Start date:
February 01, 2020
Estimated Completion Date:
May 20, 2022

Study 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.

Connect with a study center

  • Ain shams university

    Cairo,
    Egypt

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.