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OpenTrials
Completed

NCT Number: NCT06054100

The Effect of Colchicine on Inflammation in ACS Patients

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine Tablets

Drug

Colchicine oral tablets loading dose of 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months

Other names: Colchicine

Primary outcomes

  1. Effect of colchicine therapy on sST2 levels in ACS patients

    Time frame: 3 months

    sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months

Secondary outcomes

  1. Effect of colchicine therapy on occurrence of ischemic events in ACS patients

    Time frame: 3 months

    Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period

  2. Change in left ventricular ejection fraction

    Time frame: 3 months

    Effect of colchicine therapy on left ventricular ejection fraction percentage (%)

  3. Change in serum levels of IL-1beta

    Time frame: 3 months

    Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L

  4. Lipid profile parameters and TG/HDL-C ratio

    Time frame: 3 months

    Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 26, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.