The Effect of Colchicine on Inflammation in ACS Patients

Phase 3

Completed

• Conditions: STEMI; Acute Coronary Syndrome
• Interventions: Drug: Colchicine Tablets

• Registration Number: NCT06054100
• Lead Sponsor: Ain Shams University

Brief Summary

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

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 Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-22
• Primary Completion: 2022-02-15
• Study Completion: 2022-05-20
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-22
• Last Update Submitted: 2023-09-22
• Study First Posted: 2023-09-26
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colchicine group	Colchicine Tablets	Colchicine group, Colchicine oral tablets, loading dose 1mg every 12 hrs for 1 day, followed by 0.5 mg BID for 3 months

Primary Outcome Measures

Name	Time	Method
Effect of colchicine therapy on sST2 levels in ACS patients	3 months	sST2 level in pg/ml is measured using ELISA method before PCI and after 3 months

Secondary Outcome Measures

Name	Time	Method
Effect of colchicine therapy on occurrence of ischemic events in ACS patients	3 months	Effect of colchicine on the occurrence of major adverse cardiovascular events (MACE) during the study period
Change in serum levels of IL-1beta	3 months	Effect of colchicine therapy on the change in IL-1beta serum levels in pg/L
Change in left ventricular ejection fraction	3 months	Effect of colchicine therapy on left ventricular ejection fraction percentage (%)
Lipid profile parameters and TG/HDL-C ratio	3 months	Effect of colchicine therapy on the change in lipid profile parameters and TG/HDL-C ratio

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt