The Effect of Colchicine on Inflammation in ACS Patients

Acute Coronary Syndrome Clinical Trial

Official title:

The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06054100
• Other study ID #: 2511
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2020
• Est. completion date: May 20, 2022

Study information

• Verified date: September 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 20, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Inflammation
• STEMI
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of colchicine therapy on sST2 levels in ACS patients	sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months	3 months
Secondary	Effect of colchicine therapy on occurrence of ischemic events in ACS patients	Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period	3 months
Secondary	Change in left ventricular ejection fraction	Effect of colchicine therapy on left ventricular ejection fraction percentage (%)	3 months
Secondary	Change in serum levels of IL-1beta	Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L	3 months
Secondary	Lipid profile parameters and TG/HDL-C ratio	Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio	3 months