The Effect of Colchicine on Inflammation in ACS Patients

September 22, 2023 updated by: Hanan ahmed, Ain Shams University

The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colchicine group
Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months
Drug: Colchicine Tablets
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
No Intervention: STEMI standard treatment group
Control group, STEMI standard treatment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
Change in left ventricular ejection fraction
Time Frame: 3 months
Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
3 months
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Marwa A Ahmed, Phd, Faculty of Pharmacy, Ain Shams University
  • Study Director: Lamia El Wakeel, Phd, Faculty of Pharmacy, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

February 22, 2020

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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